← Trials/Trial dossier/NCT01227564
CompletedPhase 2Results posted
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease
A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.
Lead sponsor
Asset
ACC-001
Listed sites
40
Recruiting sites
-
Enrollment
63
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•CDR global 0.5•MMSE ≥25•MRI contraindications excluded
Primary endpoint
•Brain Fibrillar Beta-Amyloid Protein (Aβ)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Secondary ID3134K1-2208Alias Study Number
Org study IDB2571010
SecondaryB2571010
NCT IDNCT01227564
Timeline
Milestones
Study first posted2010-10-25estimated
Study start2011-02 (month precision)
Primary completion2014-02actual (month precision)
Study completion2014-02actual (month precision)
Last update posted2016-02-25estimated
Results first posted2016-02-25estimated
Assets
Drug assets
Study populations
Who this study enrolls
Alzheimer’s disease
Eligibility
Who can enroll
Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Concern about a change in cognition expressed by the subject or by an informant that knows the subject well
•Mini-Mental State Examination (MMSE) score ≥ 25
•Global Clinical Dementia Rating = 0.5.
•General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening.
•Amyloid burden detected on screening brain PET scan.
•Other inclusion criteria apply
Exclusion criteria
•Significant neurological disease other than early Alzheimer's disease
•Major psychiatric disorder or symptom
•Contraindication to undergo brain MRI
•Unstable medical conditions
•Other exclusion criteria apply
Endpoints (70)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Memory
20
Global cognition
10
Neuroimaging
10
Other (unclassified)
10
Function / daily living
4
Behavior / neuropsychiatric
4
Tau biomarkers
4
Fluid / digital biomarkers
4
Amyloid biomarkers
2
Caregiver / quality of life
2
Global cognition
10 endpointsOther/protocol endpoint
Change From Baseline in Neuropsychological Test Battery (NTB)
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB)
Time frame:104 weeks
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in Mini Mental State Examination (MMSE) Total Score
Time frame:104 weeks
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in 13-item Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score
Time frame:104 weeks
ADAS-Cog
change from baseline, improvement
Other/protocol endpoint
Percentage of Participants With a Global CDR Score of Equal to or Greater Than 1 for the First Time
Time frame:104 weeks
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
threshold achievement, improvement
Other_pre_specified/registry result
Change From Baseline in Neuropsychological Test Battery (NTB)
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), z-scores | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 20, 20, 40, 19)n=22 Participants | -0.14 | --0.28 - 0.00 |
| Week 52 (N: 22, 19, 41, 20)n=22 Participants | -0.08 | --0.26 - 0.09 |
| Week 78 (N: 22, 18, 40, 18)n=22 Participants | -0.31 | --0.52 - -0.10 |
| Week 104 (N: 18, 18, 36, 15)n=22 Participants | -0.42 | --0.71 - -0.14 |
| ACC 10 μg+QS-21Week 26 (N: 20, 20, 40, 19)n=20 Participants | -0.07 | --0.21 - 0.08 |
| Week 52 (N: 22, 19, 41, 20)n=20 Participants | -0.08 | --0.27 - 0.11 |
| Week 78 (N: 22, 18, 40, 18)n=20 Participants | 0.01 | --0.22 - 0.23 |
| Week 104 (N: 18, 18, 36, 15)n=20 Participants | -0.12 | --0.42 - 0.18 |
| Overall ACC + QS21Week 26 (N: 20, 20, 40, 19)n=42 Participants | -0.10 | --0.20 - 0.00 |
| Week 52 (N: 22, 19, 41, 20)n=42 Participants | -0.08 | --0.21 - 0.05 |
| Week 78 (N: 22, 18, 40, 18)n=42 Participants | -0.15 | --0.31 - 0.00 |
| Week 104 (N: 18, 18, 36, 15)n=42 Participants | -0.27 | --0.48 - -0.06 |
| PlaceboWeek 26 (N: 20, 20, 40, 19)n=21 Participants | -0.11 | --0.25 - 0.04 |
| Week 52 (N: 22, 19, 41, 20)n=21 Participants | -0.06 | --0.25 - 0.12 |
| Week 78 (N: 22, 18, 40, 18)n=21 Participants | -0.27 | --0.50 - -0.04 |
| Week 104 (N: 18, 18, 36, 15)n=21 Participants | -0.45 | --0.76 - -0.14 |
Mean Difference (Final Values)-0.0395% CI-0.23 - 0.17p0.7687Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.0495% CI-0.16 - 0.24p0.6804Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.0195% CI-0.17 - 0.18p0.9452Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.0295% CI-0.27 - 0.23p0.8825Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.0295% CI-0.28 - 0.24p0.8791Mixed-Effects Model Repeated Measures
Median Difference (Final Values)-0.0295% CI-0.24 - 0.20p0.8628Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.0495% CI-0.35 - 0.26p0.7843Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.2895% CI-0.04 - 0.60p0.0857Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.1295% CI-0.15 - 0.39p0.3878Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.0395% CI-0.39 - 0.45p0.8918Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.3395% CI-0.09 - 0.76p0.1233Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.1895% CI-0.19 - 0.55p0.3302Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB)
Time frame:104 weeks
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), score | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20, 42, 20)n=22 Participants | 0.60 | -0.20 - 1.00 |
| Week 52 (N: 22, 19, 41, 20)n=22 Participants | 1.10 | -0.53 - 1.66 |
| Week 78 (N: 22, 18, 40, 18)n=22 Participants | 1.71 | -1.04 - 2.39 |
| Week 104 (N: 17, 18, 35, 14)n=22 Participants | 2.15 | -1.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20, 42, 20)n=20 Participants | 0.31 | --0.11 - 0.73 |
| Week 52 (N: 22, 19, 41, 20)n=20 Participants | 0.39 | --0.21 - 0.99 |
| Week 78 (N: 22, 18, 40, 18)n=20 Participants | 0.69 | --0.04 - 1.41 |
| Week 104 (N: 17, 18, 35, 14)n=20 Participants | 1.23 | -0.37 - 2.10 |
| Overall ACC + QS21Week 26 (N: 22, 20, 42, 20)n=42 Participants | 0.46 | -0.16 - 0.75 |
| Week 52 (N: 22, 19, 41, 20)n=42 Participants | 0.74 | -0.33 - 1.16 |
| Week 78 (N: 22, 18, 40, 18)n=42 Participants | 1.20 | -0.70 - 1.70 |
| Week 104 (N: 17, 18, 35, 14)n=42 Participants | 1.69 | -1.09 - 2.29 |
| PlaceboWeek 26 (N: 22, 20, 42, 20)n=21 Participants | 0.21 | --0.22 - 0.63 |
| Week 52 (N: 22, 19, 41, 20)n=21 Participants | 0.71 | -0.11 - 1.31 |
| Week 78 (N: 22, 18, 40, 18)n=21 Participants | 1.25 | -0.53 - 1.97 |
| Week 104 (N: 17, 18, 35, 14)n=21 Participants | 1.11 | -0.23 - 2.00 |
Mean Difference (Final Values)0.3995% CI-0.18 - 0.96p0.1796Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.1095% CI-0.49 - 0.69p0.7281Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.2595% CI-0.26 - 0.75p0.3347Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.3995% CI-0.43 - 1.20p0.3425Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.3295% CI-1.16 - 0.52p0.4501Mixed-Effects Model Repeated Measures
Median Difference (Final Values)0.0495% CI-0.68 - 0.75p0.9227Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.4795% CI-0.51 - 1.45p0.3450Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.5695% CI-1.58 - 0.45p0.2740Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.0595% CI-0.92 - 0.82p0.9140Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)1.0395% CI-0.18 - 2.24p0.0923Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.1295% CI-1.11 - 1.35p0.8482Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.5795% CI-0.49 - 1.64p0.2840Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result
Change From Baseline in Mini Mental State Examination (MMSE) Total Score
Time frame:104 weeks
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), score | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20, 42, 20)n=22 Participants | -1.06 | --2.20 - 0.09 |
| Week 52 (N: 22, 19, 41, 20)n=22 Participants | -2.46 | --3.72 - -1.21 |
| Week 78 (N: 22, 18, 40, 18)n=22 Participants | -2.28 | --3.75 - -0.82 |
| Week 104 (N: 19, 18, 37, 15)n=22 Participants | -3.55 | --5.48 - -1.63 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20, 42, 20)n=20 Participants | -1.09 | --2.28 - 0.09 |
| Week 52 (N: 22, 19, 41, 20)n=20 Participants | -1.54 | --2.87 - -0.20 |
| Week 78 (N: 22, 18, 40, 18)n=20 Participants | -1.92 | --3.48 - -0.35 |
| Week 104 (N: 19, 18, 37, 15)n=20 Participants | -1.34 | --3.37 - 0.68 |
| Overall ACC + QS21Week 26 (N: 22, 20, 42, 20)n=42 Participants | -1.08 | --1.90 - -0.25 |
| Week 52 (N: 22, 19, 41, 20)n=42 Participants | -2.00 | --2.92 - -1.08 |
| Week 78 (N: 22, 18, 40, 18)n=42 Participants | -2.10 | --3.17 - -1.03 |
| Week 104 (N: 19, 18, 37, 15)n=42 Participants | -2.45 | --3.85 - -1.05 |
| PlaceboWeek 26 (N: 22, 20, 42, 20)n=21 Participants | -1.10 | --2.29 - 0.09 |
| Week 52 (N: 22, 19, 41, 20)n=21 Participants | -1.30 | --2.62 - -0.01 |
| Week 78 (N: 22, 18, 40, 18)n=21 Participants | -1.42 | --2.97 - -0.13 |
| Week 104 (N: 19, 18, 37, 15)n=21 Participants | -2.53 | --4.62 - -0.44 |
Mean Difference (Final Values)0.0595% CI-1.58 - 1.68p0.9535Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.0195% CI-1.63 - 1.65p0.9914Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.0395% CI-1.39 - 1.44p0.9682Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.1695% CI-2.96 - 0.64p0.2008Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.2395% CI-2.07 - 1.60p0.7988Mixed-Effects Model Repeated Measures
Median Difference (Final Values)-0.7095% CI-2.27 - 0.87p0.3764Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.8695% CI-2.98 - 1.25p0.4177Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.5095% CI-2.67 - 1.68p0.6494Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.6895% CI-2.54 - 1.18p0.4674Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.0295% CI-3.85 - 1.81p0.4709Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)1.1995% CI-1.70 - 4.07p0.4128Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.0895% CI-2.41 - 2.58p0.9478Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result
Change From Baseline in 13-item Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) Total Score
Time frame:104 weeks
ADAS-Cog
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), score | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 54 (N: 22, 19, 41, 29)n=22 Participants | -5.58 | --7.55 - -3.61 |
| Week 86 (N: 19, 18, 37, 17)n=22 Participants | 1.80 | --0.04 - 3.65 |
| ACC 10 μg+QS-21Week 54 (N: 22, 19, 41, 29)n=20 Participants | -6.69 | --8.83 - -4.55 |
| Week 86 (N: 19, 18, 37, 17)n=20 Participants | 0.28 | --1.65 - 2.22 |
| Overall ACC + QS21Week 54 (N: 22, 19, 41, 29)n=42 Participants | -6.14 | --7.61 - -4.67 |
| Week 86 (N: 19, 18, 37, 17)n=42 Participants | 1.04 | --0.31 - 2.39 |
| PlaceboWeek 54 (N: 22, 19, 41, 29)n=21 Participants | -5.05 | --7.21 - -2.90 |
| Week 86 (N: 19, 18, 37, 17)n=21 Participants | 1.56 | --0.43 - 3.55 |
Mean Difference (Final Values)-0.5395% CI-3.40 - 2.35p0.7146Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.6495% CI-4.60 - 1.33p0.2733Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.0895% CI-3.62 - 1.46p0.3969Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.2495% CI-2.43 - 2.92p0.8566Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.2895% CI-3.98 - 1.42p0.3460Mixed-Effects Model Repeated Measures
Median Difference (Final Values)-0.5295% CI-2.86 - 1.82p0.6582Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result
Percentage of Participants With a Global CDR Score of Equal to or Greater Than 1 for the First Time
Time frame:104 weeks
Clinical Dementia Rating-Sum of Boxes (CDR-SB)
threshold achievement, improvement
Posted result
| Group | Value (number), percentage of participants | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26n=22 Participants | 86.4 | - |
| Week 52n=22 Participants | 0.0 | - |
| Week 78n=22 Participants | 13.6 | - |
| Week 104n=22 Participants | 0.0 | - |
| ACC 10 μg+QS-21Week 26n=20 Participants | 70.0 | - |
| Week 52n=20 Participants | 15.0 | - |
| Week 78n=20 Participants | 0.0 | - |
| Week 104n=20 Participants | 10.0 | - |
| Overall ACC + QS21Week 26n=42 Participants | 78.6 | - |
| Week 52n=42 Participants | 7.1 | - |
| Week 78n=42 Participants | 7.1 | - |
| Week 104n=42 Participants | 4.8 | - |
| PlaceboWeek 26n=21 Participants | 80.0 | - |
| Week 52n=21 Participants | 10.0 | - |
| Week 78n=21 Participants | 0.0 | - |
| Week 104n=21 Participants | 0.0 | - |
Memory
20 endpointsOther/protocol endpoint
Change From Baseline in Perceived Deficits Questionnaire (PDQ) - Subject - Attention/Concentration Domain Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in PDQ - Subject - Retrospective Memory Domain Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in PDQ - Subject - Prospective Memory Domain Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in PDQ - Subject - Planning/Organization Domain Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in PDQ - Subject - Total Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in PDQ-R - Relative - Attention/Concentration Domain Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in PDQ-R - Relative - Retrospective Memory Domain Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in PDQ-R - Relative - Prospective Memory Domain Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in PDQ-R - Relative - Planning/Organization Domain Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in PDQ-R - Relative - Total Score
Time frame:104 weeks
change from baseline, improvement
Other_pre_specified/registry result
Change From Baseline in Perceived Deficits Questionnaire (PDQ) - Subject - Attention/Concentration Domain Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Reported spread / bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 0.5 | 3.070.20 - 1.00 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | 0.7 | 2.410.53 - 1.66 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 0.7 | 3.271.04 - 2.39 |
| Week 104 (N: 18, 18,15)n=22 Participants | 1.6 | 3.541.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | 0.1 | 2.95-0.11 - 0.73 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | -0.1 | 2.91-0.21 - 0.99 |
| Week 78 (N: 22, 18, 18)n=20 Participants | -0.1 | 2.83-0.04 - 1.41 |
| Week 104 (N: 18, 18,15)n=20 Participants | 1.1 | 3.140.37 - 2.10 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | 0.5 | 3.49-0.22 - 0.63 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | 0.7 | 3.340.11 - 1.31 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 1.4 | 3.660.53 - 1.97 |
| Week 104 (N: 18, 18,15)n=21 Participants | 1.3 | 3.790.23 - 2.00 |
Other_pre_specified/registry result
Change From Baseline in PDQ - Subject - Retrospective Memory Domain Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Reported spread / bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 0.5 | 3.110.20 - 1.00 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | 0.0 | 2.820.53 - 1.66 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 1.0 | 3.781.04 - 2.39 |
| Week 104 (N: 18, 18,15)n=22 Participants | 1.6 | 3.471.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | -1.2 | 2.89-0.11 - 0.73 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | 0.2 | 2.52-0.21 - 0.99 |
| Week 78 (N: 22, 18, 18)n=20 Participants | 0.1 | 2.61-0.04 - 1.41 |
| Week 104 (N: 18, 18,15)n=20 Participants | -0.3 | 2.590.37 - 2.10 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | 0.4 | 4.21-0.22 - 0.63 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | 0.5 | 4.120.11 - 1.31 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 1.2 | 4.140.53 - 1.97 |
| Week 104 (N: 18, 18,15)n=21 Participants | 1.4 | 5.030.23 - 2.00 |
Other_pre_specified/registry result
Change From Baseline in PDQ - Subject - Prospective Memory Domain Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Reported spread / bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 0.1 | 2.650.20 - 1.00 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | 0.4 | 2.940.53 - 1.66 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 0.3 | 2.511.04 - 2.39 |
| Week 104 (N: 18, 18,15)n=22 Participants | 0.5 | 2.661.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | -0.1 | 2.17-0.11 - 0.73 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | 0.1 | 1.73-0.21 - 0.99 |
| Week 78 (N: 22, 18, 18)n=20 Participants | -0.1 | 1.43-0.04 - 1.41 |
| Week 104 (N: 18, 18,15)n=20 Participants | 0.6 | 1.940.37 - 2.10 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | -0.7 | 3.48-0.22 - 0.63 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | -0.1 | 2.700.11 - 1.31 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 0.9 | 2.800.53 - 1.97 |
| Week 104 (N: 18, 18,15)n=21 Participants | 1.3 | 3.880.23 - 2.00 |
Other_pre_specified/registry result
Change From Baseline in PDQ - Subject - Planning/Organization Domain Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Reported spread / bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 0.3 | 3.390.20 - 1.00 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | 0.3 | 2.910.53 - 1.66 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 1.0 | 3.731.04 - 2.39 |
| Week 104 (N: 18, 18,15)n=22 Participants | 1.6 | 3.351.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | -0.4 | 2.08-0.11 - 0.73 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | -0.1 | 2.53-0.21 - 0.99 |
| Week 78 (N: 22, 18, 18)n=20 Participants | 1.2 | 1.80-0.04 - 1.41 |
| Week 104 (N: 18, 18,15)n=20 Participants | 1.0 | 2.450.37 - 2.10 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | -0.4 | 3.05-0.22 - 0.63 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | 0.3 | 3.260.11 - 1.31 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 0.9 | 4.340.53 - 1.97 |
| Week 104 (N: 18, 18,15)n=21 Participants | 1.3 | 3.790.23 - 2.00 |
Other_pre_specified/registry result
Change From Baseline in PDQ - Subject - Total Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Standard deviation |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 1.4 | 10.72 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | 1.5 | 8.60 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 3.0 | 11.03 |
| Week 104 (N: 18, 18,15)n=22 Participants | 5.2 | 10.76 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | -1.6 | 7.54 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | 0.2 | 7.83 |
| Week 78 (N: 22, 18, 18)n=20 Participants | 1.2 | 6.53 |
| Week 104 (N: 18, 18,15)n=20 Participants | 2.4 | 8.36 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | -0.3 | 12.95 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | 1.5 | 11.60 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 4.4 | 13.74 |
| Week 104 (N: 18, 18,15)n=21 Participants | 5.3 | 15.63 |
Other_pre_specified/registry result
Change From Baseline in PDQ-R - Relative - Attention/Concentration Domain Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Reported spread / bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 2.0 | 3.370.20 - 1.00 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | 2.0 | 3.430.53 - 1.66 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 2.9 | 3.381.04 - 2.39 |
| Week 104 (N: 17, 18,15)n=22 Participants | 3.9 | 3.521.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | -0.1 | 3.85-0.11 - 0.73 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | -0.1 | 3.85-0.21 - 0.99 |
| Week 78 (N: 22, 18, 18)n=20 Participants | 0.9 | 3.77-0.04 - 1.41 |
| Week 104 (N: 17, 18,15)n=20 Participants | 1.1 | 3.160.37 - 2.10 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | 0.9 | 2.83-0.22 - 0.63 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | 1.8 | 2.750.11 - 1.31 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 2.0 | 3.140.53 - 1.97 |
| Week 104 (N: 17, 18,15)n=21 Participants | 1.1 | 4.160.23 - 2.00 |
Other_pre_specified/registry result
Change From Baseline in PDQ-R - Relative - Retrospective Memory Domain Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Reported spread / bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 1.3 | 3.490.20 - 1.00 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | 1.7 | 2.950.53 - 1.66 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 2.3 | 2.551.04 - 2.39 |
| Week 104 (N: 18, 18,15)n=22 Participants | 3.1 | 3.031.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | 0.0 | 2.83-0.11 - 0.73 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | 0.4 | 2.55-0.21 - 0.99 |
| Week 78 (N: 22, 18, 18)n=20 Participants | 1.2 | 2.57-0.04 - 1.41 |
| Week 104 (N: 18, 18,15)n=20 Participants | 1.7 | 2.890.37 - 2.10 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | 1.8 | 2.57-0.22 - 0.63 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | 1.4 | 2.410.11 - 1.31 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 2.2 | 2.090.53 - 1.97 |
| Week 104 (N: 18, 18,15)n=21 Participants | 1.7 | 3.990.23 - 2.00 |
Other_pre_specified/registry result
Change From Baseline in PDQ-R - Relative - Prospective Memory Domain Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Reported spread / bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 1.0 | 2.130.20 - 1.00 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | 0.6 | 2.220.53 - 1.66 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 1.5 | 2.371.04 - 2.39 |
| Week 104 (N: 18, 18,15)n=22 Participants | 2.6 | 2.481.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | -0.4 | 2.08-0.11 - 0.73 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | 0.3 | 2.51-0.21 - 0.99 |
| Week 78 (N: 22, 18, 18)n=20 Participants | 0.2 | 2.53-0.04 - 1.41 |
| Week 104 (N: 18, 18,15)n=20 Participants | 0.9 | 2.310.37 - 2.10 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | 1.1 | 2.19-0.22 - 0.63 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | 1.0 | 2.860.11 - 1.31 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 0.8 | 2.920.53 - 1.97 |
| Week 104 (N: 18, 18,15)n=21 Participants | 0.5 | 3.760.23 - 2.00 |
Other_pre_specified/registry result
Change From Baseline in PDQ-R - Relative - Planning/Organization Domain Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Reported spread / bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 1.9 | 3.070.20 - 1.00 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | 1.7 | 3.280.53 - 1.66 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 2.5 | .361.04 - 2.39 |
| Week 104 (N: 18, 18,15)n=22 Participants | 2.7 | 3.871.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | -0.2 | 2.76-0.11 - 0.73 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | 0.3 | 4.27-0.21 - 0.99 |
| Week 78 (N: 22, 18, 18)n=20 Participants | -0.1 | 3.39-0.04 - 1.41 |
| Week 104 (N: 18, 18,15)n=20 Participants | 1.1 | 3.900.37 - 2.10 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | 1.7 | 2.80-0.22 - 0.63 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | 1.7 | 2.740.11 - 1.31 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 1.9 | 2.910.53 - 1.97 |
| Week 104 (N: 18, 18,15)n=21 Participants | 1.0 | 3.630.23 - 2.00 |
Other_pre_specified/registry result
Change From Baseline in PDQ-R - Relative - Total Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Reported spread / bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 6.2 | 10.690.20 - 1.00 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | 6.0 | 9.910.53 - 1.66 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 9.2 | 9.501.04 - 2.39 |
| Week 104 (N: 17, 18,15)n=22 Participants | 12.8 | 10.591.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | -0.6 | 10.37-0.11 - 0.73 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | 0.9 | 11.65-0.21 - 0.99 |
| Week 78 (N: 22, 18, 18)n=20 Participants | 2.2 | 10.30-0.04 - 1.41 |
| Week 104 (N: 17, 18,15)n=20 Participants | 4.8 | 9.980.37 - 2.10 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | 5.4 | 8.03-0.22 - 0.63 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | 5.7 | 7.890.11 - 1.31 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 6.9 | 8.900.53 - 1.97 |
| Week 104 (N: 17, 18,15)n=21 Participants | 4.3 | 13.680.23 - 2.00 |
Function / daily living
4 endpointsOther/protocol endpoint
Change From Baseline in Functional Activities Questionnaire (FAQ) Total Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in Resource Utilization in Dementia (RUD) (Abbreviated) (RUD-Lite) - Primary Caregiver
Time frame:104 weeks
change from baseline, improvement
Other_pre_specified/registry result
Change From Baseline in Functional Activities Questionnaire (FAQ) Total Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), score | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20, 42, 19)n=22 Participants | 3.45 | -1.89 - 5.02 |
| Week 52 (N: 22, 19, 41, 19)n=22 Participants | 4.63 | -2.71 - 6.55 |
| Week 78 (N: 22, 18, 40, 17)n=22 Participants | 5.36 | -3.03 - 7.69 |
| Week 104 (N: 18, 18, 36, 14)n=22 Participants | 6.90 | -4.25 - 9.55 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20, 42, 19)n=20 Participants | 0.25 | --1.44 - 1.94 |
| Week 52 (N: 22, 19, 41, 19)n=20 Participants | 0.98 | --1.10 - 3.06 |
| Week 78 (N: 22, 18, 40, 17)n=20 Participants | 2.09 | --0.45 - 4.64 |
| Week 104 (N: 18, 18, 36, 14)n=20 Participants | 3.11 | -0.33 - 5.89 |
| Overall ACC + QS21Week 26 (N: 22, 20, 42, 19)n=42 Participants | 1.85 | -0.68 - 3.03 |
| Week 52 (N: 22, 19, 41, 19)n=42 Participants | 2.81 | -1.37 - 4.24 |
| Week 78 (N: 22, 18, 40, 17)n=42 Participants | 3.73 | -1.99 - 5.47 |
| Week 104 (N: 18, 18, 36, 14)n=42 Participants | 5.01 | -3.07 - 6.94 |
| PlaceboWeek 26 (N: 22, 20, 42, 19)n=21 Participants | 1.80 | -0.02 - 3.58 |
| Week 52 (N: 22, 19, 41, 19)n=21 Participants | 2.85 | -0.71 - 4.99 |
| Week 78 (N: 22, 18, 40, 17)n=21 Participants | 4.89 | -2.26 - 7.51 |
| Week 104 (N: 18, 18, 36, 14)n=21 Participants | 4.66 | -1.66 - 7.66 |
Mean Difference (Final Values)1.6595% CI-0.67 - 3.97p0.1597Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.5595% CI-4.01 - 0.91p0.2130Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.0595% CI-2.06 - 2.16p0.9616Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)1.7895% CI-1.06 - 4.62p0.2143Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.8795% CI-4.87 - 1.12p0.2151Mixed-Effects Model Repeated Measures
Median Difference (Final Values)-0.0595% CI-2.61 - 2.51p0.9704Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.4795% CI-3.00 - 3.95p0.7857Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-2.7995% CI-6.45 - 0.87p0.1323Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.1695% CI-4.29 - 1.97p0.4618Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)2.2495% CI-1.74 - 6.22p0.2622Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.5595% CI-5.64 - 2.55p0.4499Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.3595% CI-3.21 - 3.91p0.8454Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result
Change From Baseline in Resource Utilization in Dementia (RUD) (Abbreviated) (RUD-Lite) - Primary Caregiver
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), hours | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20, 20)n=22 Participants | 3.97 | --7.02 - 14.97 |
| Week 52 (N: 22, 19, 20)n=22 Participants | 16.76 | -0.60 - 32.93 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 30.80 | --10.69 - 72.29 |
| Week 104 (N: 18, 18, 15)n=22 Participants | 36.36 | -15.37 - 57.34 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20, 20)n=20 Participants | -6.05 | --17.57 - 5.47 |
| Week 52 (N: 22, 19, 20)n=20 Participants | -7.97 | --25.41 - 9.47 |
| Week 78 (N: 22, 18, 18)n=20 Participants | -3.23 | --49.00 - 42.54 |
| Week 104 (N: 18, 18, 15)n=20 Participants | -5.88 | --27.65 - 15.88 |
| PlaceboWeek 26 (N: 22, 20, 20)n=21 Participants | 6.47 | --5.23 - 18.17 |
| Week 52 (N: 22, 19, 20)n=21 Participants | 21.73 | -4.66 - 38.79 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 61.74 | -15.98 - 107.51 |
| Week 104 (N: 18, 18, 15)n=21 Participants | 20.31 | --2.29 - 42.92 |
Mean Difference (Final Values)-2.5095% CI-18.36 - 13.36p0.7537Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-12.5195% CI-28.86 - 3.65p0.1266Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-4.9695% CI-28.34 - 18.41p0.6724Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-29.7095% CI-53.89 - -5.50p0.0170Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-30.9495% CI-92.67 - 30.78p0.3196Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-64.9795% CI-129.64 - -0.31p0.0490Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)16.0495% CI-14.70 - 46.79p0.2969Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-26.2095% CI-57.42 - 5.03p0.0973Mixed-Effects Model Repeated Measures
Behavior / neuropsychiatric
4 endpointsOther/protocol endpoint
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
Time frame:104 weeks
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in NPI Distress Score (NPI-D)
Time frame:104 weeks
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Other_pre_specified/registry result
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score
Time frame:104 weeks
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), score | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20, 42, 20)n=22 Participants | 1.51 | --0.50 - 3.52 |
| Week 52 (N: 22, 19, 41, 20)n=22 Participants | 1.97 | --0.31 - 4.25 |
| Week 78 (N: 22, 18, 40, 18)n=22 Participants | 2.01 | --0.15 - 4.18 |
| Week 104 (N: 18, 18, 36, 15)n=22 Participants | 1.38 | --0.53 - 3.29 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20, 42, 20)n=20 Participants | -0.76 | --2.87 - 1.35 |
| Week 52 (N: 22, 19, 41, 20)n=20 Participants | 2.44 | --0.00 - 4.89 |
| Week 78 (N: 22, 18, 40, 18)n=20 Participants | 1.17 | --1.19 - 3.53 |
| Week 104 (N: 18, 18, 36, 15)n=20 Participants | 1.31 | --0.61 - 3.22 |
| Overall ACC + QS21Week 26 (N: 22, 20, 42, 20)n=42 Participants | 0.38 | --1.09 - 1.84 |
| Week 52 (N: 22, 19, 41, 20)n=42 Participants | 2.21 | -0.52 - 3.89 |
| Week 78 (N: 22, 18, 40, 18)n=42 Participants | 1.59 | --0.02 - 320 |
| Week 104 (N: 18, 18, 36, 15)n=42 Participants | 1.34 | --0.03 - 2.71 |
| PlaceboWeek 26 (N: 22, 20, 42, 20)n=21 Participants | 3.50 | -1.37 - 5.64 |
| Week 52 (N: 22, 19, 41, 20)n=21 Participants | 2.65 | -0.24 - 5.06 |
| Week 78 (N: 22, 18, 40, 18)n=21 Participants | 3.34 | -0.97 - 5.71 |
| Week 104 (N: 18, 18, 36, 15)n=21 Participants | 2.08 | --0.03 - 4.19 |
Mean Difference (Final Values)-1.9995% CI-4.90 - 0.92p0.1767Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-4.2695% CI-7.23 - -1.29p0.0057Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-3.1395% CI-5.69 - -0.57p0.0176Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.6895% CI-3.98 - 2.61p0.6790Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.2195% CI-3.62 - 3.20p0.9028Mixed-Effects Model Repeated Measures
Median Difference (Final Values)-0.4595% CI-3.36 - 2.47p0.7600Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.3295% CI-4.51 - 1.86p0.4089Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-2.1795% CI-5.49 - 1.15p0.1964Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.7595% CI-4.58 - 1.09p0.2234Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.7095% CI-3.52 - 2.12p0.6186Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.7795% CI-3.60 - 2.06p0.5853Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.7495% CI-3.23 - 1.75p0.5541Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result
Change From Baseline in NPI Distress Score (NPI-D)
Time frame:104 weeks
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), score | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20, 42, 20)n=22 Participants | 1.49 | -0.11 - 2.87 |
| Week 52 (N: 22, 19, 41, 20)n=22 Participants | 1.54 | -0.20 - 2.88 |
| Week 78 (N: 22, 18, 40, 18)n=22 Participants | 1.45 | -0.11 - 2.79 |
| Week 104 (N: 18, 18, 36, 15)n=22 Participants | 1.73 | -0.02 - 3.44 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20, 42, 20)n=20 Participants | 0.42 | --1.03 - 1.86 |
| Week 52 (N: 22, 19, 41, 20)n=20 Participants | 1.24 | --0.20 - 2.68 |
| Week 78 (N: 22, 18, 40, 18)n=20 Participants | 0.44 | --1.01 - 1.90 |
| Week 104 (N: 18, 18, 36, 15)n=20 Participants | 1.76 | -0.03 - 3.48 |
| Overall ACC + QS21Week 26 (N: 22, 20, 42, 20)n=42 Participants | 0.95 | --0.05 - 1.96 |
| Week 52 (N: 22, 19, 41, 20)n=42 Participants | 1.39 | -0.39 - 2.38 |
| Week 78 (N: 22, 18, 40, 18)n=42 Participants | 0.95 | --0.05 - 1.94 |
| Week 104 (N: 18, 18, 36, 15)n=42 Participants | 1.74 | -0.52 - 2.97 |
| PlaceboWeek 26 (N: 22, 20, 42, 20)n=21 Participants | 1.57 | -0.10 - 3.05 |
| Week 52 (N: 22, 19, 41, 20)n=21 Participants | 2.27 | -0.84 - 3.71 |
| Week 78 (N: 22, 18, 40, 18)n=21 Participants | 2.56 | -1.08 - 4.03 |
| Week 104 (N: 18, 18, 36, 15)n=21 Participants | 1.27 | --0.62 - 3.16 |
Mean Difference (Final Values)-0.0895% CI-2.09 - 1.93p0.9370Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.1695% CI-3.19 - 0.88p0.2597Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.6295% CI-2.38 - 1.14p0.4852Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.7395% CI-2.69 - 1.22p0.4542Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.0395% CI-3.04 - 0.97p0.3061Mixed-Effects Model Repeated Measures
Median Difference (Final Values)-0.8895% CI-2.61 - 0.84p0.3082Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.1195% CI-3.09 - 0.87p0.2672Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-2.1195% CI-4.15 - -0.07p0.0427Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.6195% CI-3.37 - 0.15p0.0716Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.4695% CI-2.09 - 3.00p0.7184Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.4995% CI-2.06 - 3.03p0.7004Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.4795% CI-1.77 - 2.71p0.6723Mixed-Effects Model Repeated Measures
Amyloid biomarkers
2 endpointsPrimary/protocol endpoint
Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)
Time frame:104 weeks
change from baseline, improvement
Primary/registry result
Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), ratio | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 52 (N: 22, 19, 41, 20)n=22 Participants | 0.009 | --0.042 - 0.060 |
| Week 78 (N: 21, 18, 39, 16)n=22 Participants | -0.011 | --0.084 - 0.062 |
| Week 104 (N: 14, 15, 29, 13)n=22 Participants | -0.018 | --0.097 - 0.061 |
| ACC 10 μg+QS-21Week 52 (N: 22, 19, 41, 20)n=20 Participants | 0.017 | --0.039 - 0.073 |
| Week 78 (N: 21, 18, 39, 16)n=20 Participants | -0.022 | --0.101 - 0.057 |
| Week 104 (N: 14, 15, 29, 13)n=20 Participants | -0.018 | --0.098 - 0.062 |
| Overall ACC + QS21Week 52 (N: 22, 19, 41, 20)n=42 Participants | 0.013 | --0.025 - 0.051 |
| Week 78 (N: 21, 18, 39, 16)n=42 Participants | -0.017 | --0.071 - 0.038 |
| Week 104 (N: 14, 15, 29, 13)n=42 Participants | -0.018 | --0.075 - 0.038 |
| PlaceboWeek 52 (N: 22, 19, 41, 20)n=21 Participants | 0.011 | --0.043 - 0.065 |
| Week 78 (N: 21, 18, 39, 16)n=21 Participants | -0.014 | --0.096 - 0.068 |
| Week 104 (N: 14, 15, 29, 13)n=21 Participants | 0.032 | --0.052 - 0.115 |
Mean Difference (Final Values)-0.00295% CI-0.075 - 0.071p0.9538Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00695% CI-0.070 - 0.081p0.8787Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00295% CI-0.062 - 0.066p0.9544Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00395% CI-0.106 - 0.112p0.9550Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.00895% CI-0.121 - 0.105p0.8874Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.00295% CI-0.099 - 0.095p0.9595Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.05095% CI-0.164 - 0.064p0.3826Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.04995% CI-0.164 - 0.065p0.3912Mixed-Effects Model Repeated Measures
Median Difference (Final Values)-0.05095% CI-0.149 - 0.050p0.3221Mixed-Effects Model Repeated Measures
Tau biomarkers
4 endpointsOther/protocol endpoint
Change From Baseline in CSF p-Tau
Time frame:Week 80 or Week 104
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in CSF Total Tau
Time frame:Week 80 or Week 104
change from baseline, improvement
Other_pre_specified/registry result
Change From Baseline in CSF p-Tau
Time frame:Week 80 or Week 104
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), μg/ml | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21n=22 Participants | -2.32 | --6.80 - 2.15 |
| ACC 10 μg+QS-21n=18 Participants | -3.47 | --8.43 - 1.49 |
| Overall ACC + QS21n=40 Participants | -2.90 | --6.14 - 0.35 |
| Placebon=17 Participants | 1.03 | --3.89 - 5.96 |
Mean Difference (Final Values)-3.3695% CI-9.94 - 3.22p0.3106ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Mean Difference (Final Values)-4.5195% CI-11.28 - 2.27p0.1876ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Mean Difference (Final Values)-3.9395% CI-9.66 - 1.79p0.1742ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Other_pre_specified/registry result
Change From Baseline in CSF Total Tau
Time frame:Week 80 or Week 104
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), μg/ml | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21n=22 Participants | 25.56 | --24.38 - 75.50 |
| ACC 10 μg+QS-21n=18 Participants | -27.48 | --83.48 - 28.49 |
| Overall ACC + QS21n=40 Participants | -0.96 | --37.23 - 35.31 |
| Placebon=17 Participants | 55.92 | -0.97 - 110.86 |
Mean Difference (Final Values)-30.3695% CI-103.52 - 42.81p0.4089ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Mean Difference (Final Values)-83.4095% CI-159.69 - -7.11p0.0327ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Mean Difference (Final Values)-56.8895% CI-120.82 - 7.06p0.0801ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Neuroimaging
10 endpointsOther/protocol endpoint
Change From Baseline in Volumetric Brain Magnetic Resonance Imaging (MRI) Measurements in Brain Boundary Shift Integral (BBSI)
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in Volumetric Brain MRI Measurements in Ventricular Boundary Shift Integral (VBSI)
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in Volumetric Brain MRI Measurements in Hippocampal Boundary Shift Integral (HBSI), Total
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Left
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Right
Time frame:104 weeks
change from baseline, improvement
Other_pre_specified/registry result
Change From Baseline in Volumetric Brain Magnetic Resonance Imaging (MRI) Measurements in Brain Boundary Shift Integral (BBSI)
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), mL | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 10 (N: 22, 20, 42, 20)n=22 Participants | -4.100 | --6.850 - -1.351 |
| Week 24 (N: 22, 20, 42, 21)n=22 Participants | -6.080 | --8.781 - -3.379 |
| Week 50 (N: 22, 19, 41, 18)n=22 Participants | -12.329 | --15.812 - -8.846 |
| Week 76 (N: 21, 17, 38, 15)n=22 Participants | -16.579 | --21.361 - -11.797 |
| Week 104 (N: 18, 16, 34, 14)n=22 Participants | -20.982 | --26.683 - -15.101 |
| ACC 10 μg+QS-21Week 10 (N: 22, 20, 42, 20)n=20 Participants | -0.952 | --3.840 - 1.935 |
| Week 24 (N: 22, 20, 42, 21)n=20 Participants | -2.357 | --5.193 - 0.480 |
| Week 50 (N: 22, 19, 41, 18)n=20 Participants | -5.926 | --9.640 - -2.213 |
| Week 76 (N: 21, 17, 38, 15)n=20 Participants | -10.802 | --16.022 - -5.582 |
| Week 104 (N: 18, 16, 34, 14)n=20 Participants | -12.662 | --19.008 - -6.316 |
| Overall ACC + QS21Week 10 (N: 22, 20, 42, 20)n=42 Participants | -2.526 | --4.544 - -0.509 |
| Week 24 (N: 22, 20, 42, 21)n=42 Participants | -4.218 | --6.201 - -2.236 |
| Week 50 (N: 22, 19, 41, 18)n=42 Participants | -9.128 | --11.692 - -6.564 |
| Week 76 (N: 21, 17, 38, 15)n=42 Participants | -13.690 | --17.242 - -10.138 |
| Week 104 (N: 18, 16, 34, 14)n=42 Participants | -16.822 | --21.128 - -12.486 |
| PlaceboWeek 10 (N: 22, 20, 42, 20)n=21 Participants | -1.449 | --4.316 - 1.419 |
| Week 24 (N: 22, 20, 42, 21)n=21 Participants | -5.906 | --8.683 - -3.128 |
| Week 50 (N: 22, 19, 41, 18)n=21 Participants | -10.684 | --14.435 - -6.933 |
| Week 76 (N: 21, 17, 38, 15)n=21 Participants | -16.196 | --21.573 - -10.818 |
| Week 104 (N: 18, 16, 34, 14)n=21 Participants | -18.772 | --25.335 - -12.209 |
Mean Difference (Final Values)-2.65295% CI-6.570 - 1.267p0.1807Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.49795% CI-3.515 - 4.508p0.8051Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.07895% CI-4.519 - 2.364p0.5331Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.17495% CI-3.990 - 3.641p0.9274Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)3.54995% CI-0.360 - 7.458p0.0743Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)1.68795% CI-1.656 - 5.031p0.3163Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.64595% CI-6.721 - 3.430p0.5190Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)4.75895% CI-0.476 - 9.991p0.0740Mixed-Effects Model Repeated Measures
Median Difference (Final Values)5.39495% CI-2.937 - 6.049p0.4909Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.38395% CI-7.549 - 6.783p0.9151Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)5.39495% CI-2.069 - 12.857p0.1533Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)2.50695% CI-3.904 - 8.915p0.4371Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-2.21095% CI-10.999 - 6.579p0.6167Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)6.11095% CI-2.993 - 15.212p0.1844Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)1.95095% CI-5.888 - 9.878p0.6205Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result
Change From Baseline in Volumetric Brain MRI Measurements in Ventricular Boundary Shift Integral (VBSI)
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), mL | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 10 (N: 22, 20, 42, 20)n=22 Participants | 0.913 | -0.500 - 1.327 |
| Week 24 (N: 22, 20, 42, 21)n=22 Participants | 1.540 | -1.066 - 2.014 |
| Week 50 (N: 22, 19, 41, 18)n=22 Participants | 3.023 | -2.194 - 3.853 |
| Week 76 (N: 22, 17, 39, 16)n=22 Participants | 4.729 | -3.322 - 6.136 |
| Week 104 (N: 18, 16, 34, 14)n=22 Participants | 6.422 | -4.586 - 8.257 |
| ACC 10 μg+QS-21Week 10 (N: 22, 20, 42, 20)n=20 Participants | 0.643 | -0.209 - 1.076 |
| Week 24 (N: 22, 20, 42, 21)n=20 Participants | 1.229 | -0.732 - 1.726 |
| Week 50 (N: 22, 19, 41, 18)n=20 Participants | 2.242 | -1.364 - 3.120 |
| Week 76 (N: 22, 17, 39, 16)n=20 Participants | 3.445 | -1.923 - 4.967 |
| Week 104 (N: 18, 16, 34, 14)n=20 Participants | 4.970 | -2.999 - 6.941 |
| Overall ACC + QS21Week 10 (N: 22, 20, 42, 20)n=42 Participants | 0.778 | -0.474 - 1.082 |
| Week 24 (N: 22, 20, 42, 21)n=42 Participants | 1.385 | -1.038 - 1.731 |
| Week 50 (N: 22, 19, 41, 18)n=42 Participants | 2.632 | -2.027 - 3.238 |
| Week 76 (N: 22, 17, 39, 16)n=42 Participants | 4.087 | -3.050 - 5.124 |
| Week 104 (N: 18, 16, 34, 14)n=42 Participants | 5.696 | -4.348 - 7.043 |
| PlaceboWeek 10 (N: 22, 20, 42, 20)n=21 Participants | 0.496 | -0.056 - 0.935 |
| Week 24 (N: 22, 20, 42, 21)n=21 Participants | 1.533 | -1.039 - 2.027 |
| Week 50 (N: 22, 19, 41, 18)n=21 Participants | 3.038 | -2.160 - 3.915 |
| Week 76 (N: 22, 17, 39, 16)n=21 Participants | 4.474 | -2.940 - 6.008 |
| Week 104 (N: 18, 16, 34, 14)n=21 Participants | 5.770 | -3.770 - 7.769 |
Mean Difference (Final Values)0.41895% CI-0.183 - 1.018p0.1695Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.14795% CI-0.465 - 0.759p0.6331Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.28295% CI-0.247 - 0.812p0.2907Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00795% CI-0.675 - 0.688p0.9846Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.30495% CI-1.000 - 0.392p0.3845Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.14995% CI-0.748 - 0.450p0.6204Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.01495% CI-1.221 - 1.192p0.9810Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.79695% CI-2.034 - 0.443p0.2034Mixed-Effects Model Repeated Measures
Median Difference (Final Values)-0.40595% CI-1.469 - 0.659p0.4491Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.25595% CI-1.827 - 2.337p0.8074Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-1.02995% CI-3.189 - 1.131p0.3444Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.38795% CI-2.239 - 1.464p0.6772Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.65295% CI-2.063 - 3.367p0.6325Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.80095% CI-3.606 - 2.007p0.5706Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.07495% CI-2.485 - 2.337p0.9513Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result
Change From Baseline in Volumetric Brain MRI Measurements in Hippocampal Boundary Shift Integral (HBSI), Total
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), mL | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 10 (N: 22, 20, 42, 20)n=22 Participants | -0.056 | --0.097 - -0.015 |
| Week 24 (N: 22, 20, 42, 21)n=22 Participants | -0.124 | --0.167 - -0.081 |
| Week 50 (N: 22, 19, 41, 18)n=22 Participants | -0.251 | --0.316 - -0.187 |
| Week 76 (N: 22, 17, 39, 16)n=22 Participants | -0.357 | --0.460 - -0.253 |
| Week 104 (N: 18, 16, 34, 14)n=22 Participants | -0.468 | --0.601 - -0.335 |
| ACC 10 μg+QS-21Week 10 (N: 22, 20, 42, 20)n=20 Participants | -0.016 | --0.059 - 0.027 |
| Week 24 (N: 22, 20, 42, 21)n=20 Participants | -0.065 | --0.110 - -0.020 |
| Week 50 (N: 22, 19, 41, 18)n=20 Participants | -0.159 | --0.228 - -0.090 |
| Week 76 (N: 22, 17, 39, 16)n=20 Participants | -0.255 | --0.368 - -0.142 |
| Week 104 (N: 18, 16, 34, 14)n=20 Participants | -0.329 | --0.472 - -0.185 |
| Overall ACC + QS21Week 10 (N: 22, 20, 42, 20)n=42 Participants | -0.036 | --0.066 - -0.006 |
| Week 24 (N: 22, 20, 42, 21)n=42 Participants | -0.094 | --0.126 - -0.063 |
| Week 50 (N: 22, 19, 41, 18)n=42 Participants | -0.205 | --0.252 - -0.158 |
| Week 76 (N: 22, 17, 39, 16)n=42 Participants | -0.306 | --0.383 - -0.229 |
| Week 104 (N: 18, 16, 34, 14)n=42 Participants | -0.398 | --0.496 - -0.301 |
| PlaceboWeek 10 (N: 22, 20, 42, 20)n=21 Participants | -0.041 | --0.084 - 0.002 |
| Week 24 (N: 22, 20, 42, 21)n=21 Participants | -0.099 | --0.143 - -0.055 |
| Week 50 (N: 22, 19, 41, 18)n=21 Participants | -0.226 | --0.295 - -0.157 |
| Week 76 (N: 22, 17, 39, 16)n=21 Participants | -0.334 | --0.448 - -0.219 |
| Week 104 (N: 18, 16, 34, 14)n=21 Participants | -0.471 | --0.620 - -0.323 |
Mean Difference (Final Values)-0.01595% CI-0.074 - 0.043p0.6054Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.02595% CI-0.035 - 0.084p0.4087Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00595% CI-0.046 - 0.056p0.8518Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.02595% CI-0.085 - 0.036p0.4216Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.03495% CI-0.028 - 0.097p0.2730Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00595% CI-0.048 - 0.058p0.8549Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.02695% CI-0.120 - 0.068p0.5847Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.06795% CI-0.030 - 0.163p0.1740Mixed-Effects Model Repeated Measures
Median Difference (Final Values)0.02095% CI-0.063 - 0.103p0.6255Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.02395% CI-0.177 - 0.131p0.7658Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.07995% CI-0.082 - 0.240p0.3309Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.02895% CI-0.110 - 0.166p0.6872Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00395% CI-0.196 - 0.202p0.9752Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.14395% CI-0.064 - 0.349p0.1715Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.07395% CI-0.105 - 0.250p0.4145Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result
Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Left
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), mL | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 10 (N: 22, 20, 42, 20)n=22 Participants | -0.029 | --0.051 - -0.007 |
| Week 24 (N: 22, 20, 42, 21)n=22 Participants | -0.057 | --0.081 - -0.034 |
| Week 50 (N: 22, 19, 41, 18)n=22 Participants | -0.119 | --0.152 - -0.086 |
| Week 76 (N: 22, 17, 39, 16)n=22 Participants | -0.163 | --0.213 - -0.114 |
| Week 104 (N: 18, 16, 34, 14)n=22 Participants | -0.222 | --0.288 - -0.155 |
| ACC 10 μg+QS-21Week 10 (N: 22, 20, 42, 20)n=20 Participants | -0.010 | --0.034 - 0.014 |
| Week 24 (N: 22, 20, 42, 21)n=20 Participants | -0.037 | --0.062 - -0.012 |
| Week 50 (N: 22, 19, 41, 18)n=20 Participants | -0.080 | --0.115 - -0.045 |
| Week 76 (N: 22, 17, 39, 16)n=20 Participants | -0.117 | --0.171 - -0.064 |
| Week 104 (N: 18, 16, 34, 14)n=20 Participants | -0.158 | --0.230 - -0.086 |
| Overall ACC + QS21Week 10 (N: 22, 20, 42, 20)n=42 Participants | -0.020 | --0.036 - -0.003 |
| Week 24 (N: 22, 20, 42, 21)n=42 Participants | -0.047 | --0.064 - -0.030 |
| Week 50 (N: 22, 19, 41, 18)n=42 Participants | -0.099 | --0.124 - -0.075 |
| Week 76 (N: 22, 17, 39, 16)n=42 Participants | -0.140 | --0.177 - -0.104 |
| Week 104 (N: 18, 16, 34, 14)n=42 Participants | -0.190 | --0.239 - -0.140 |
| PlaceboWeek 10 (N: 22, 20, 42, 20)n=21 Participants | -0.019 | --0.042 - 0.005 |
| Week 24 (N: 22, 20, 42, 21)n=21 Participants | -0.040 | --0.064 - -0.015 |
| Week 50 (N: 22, 19, 41, 18)n=21 Participants | -0.107 | --0.142 - -0.072 |
| Week 76 (N: 22, 17, 39, 16)n=21 Participants | -0.157 | --0.211 - -0.102 |
| Week 104 (N: 18, 16, 34, 14)n=21 Participants | -0.230 | --0.305 - -0.155 |
Mean Difference (Final Values)-0.01195% CI-0.043 - 0.022p0.5134Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00895% CI-0.024 - 0.041p0.6083Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.00195% CI-0.029 - 0.027p0.9401Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.01895% CI-0.051 - 0.016p0.2950Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00395% CI-0.031 - 0.037p0.8817Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.00895% CI-0.037 - 0.022p0.6072Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.01295% CI-0.060 - 0.036p0.6259Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.02795% CI-0.023 - 0.076p0.2807Mixed-Effects Model Repeated Measures
Median Difference (Final Values)0.00895% CI-0.035 - 0.050p0.7224Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.00795% CI-0.080 - 0.067p0.8532Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.03995% CI-0.038 - 0.116p0.3116Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.01695% CI-0.049 - 0.082p0.6246Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00895% CI-0.092 - 0.108p0.8697Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.07295% CI-0.032 - 0.176p0.1707Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.04095% CI-0.049 - 0.129p0.3732Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result
Change From Baseline in Volumetric Brain MRI Measurements in HBSI, Right
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), mL | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 10 (N: 22, 20, 42, 20)n=22 Participants | -0.027 | --0.051 - -0.004 |
| Week 24 (N: 22, 20, 42, 21)n=22 Participants | -0.067 | --0.091 - -0.044 |
| Week 50 (N: 22, 19, 41, 18)n=22 Participants | -0.133 | --0.168 - -0.098 |
| Week 76 (N: 22, 17, 39, 16)n=22 Participants | -0.194 | --0.252 - -0.135 |
| Week 104 (N: 18, 16, 34, 14)n=22 Participants | -0.247 | --0.318 - -0.175 |
| ACC 10 μg+QS-21Week 10 (N: 22, 20, 42, 20)n=20 Participants | -0.005 | --0.030 - 0.020 |
| Week 24 (N: 22, 20, 42, 21)n=20 Participants | -0.027 | --0.052 - -0.002 |
| Week 50 (N: 22, 19, 41, 18)n=20 Participants | -0.078 | --0.116 - -0.041 |
| Week 76 (N: 22, 17, 39, 16)n=20 Participants | -0.136 | --0.199 - -0.072 |
| Week 104 (N: 18, 16, 34, 14)n=20 Participants | -0.170 | --0.247 - -0.093 |
| Overall ACC + QS21Week 10 (N: 22, 20, 42, 20)n=42 Participants | -0.016 | --0.033 - 0.001 |
| Week 24 (N: 22, 20, 42, 21)n=42 Participants | -0.047 | --0.064 - -0.030 |
| Week 50 (N: 22, 19, 41, 18)n=42 Participants | -0.106 | --0.132 - -0.080 |
| Week 76 (N: 22, 17, 39, 16)n=42 Participants | -0.165 | --0.208 - -0.121 |
| Week 104 (N: 18, 16, 34, 14)n=42 Participants | -0.208 | --0.261 - -0.156 |
| PlaceboWeek 10 (N: 22, 20, 42, 20)n=21 Participants | -0.021 | --0.046 - 0.003 |
| Week 24 (N: 22, 20, 42, 21)n=21 Participants | -0.059 | --0.084 - -0.035 |
| Week 50 (N: 22, 19, 41, 18)n=21 Participants | -0.119 | --0.157 - -0.081 |
| Week 76 (N: 22, 17, 39, 16)n=21 Participants | -0.177 | --0.242 - -0.113 |
| Week 104 (N: 18, 16, 34, 14)n=21 Participants | -0.240 | --0.320 - -0.161 |
Mean Difference (Final Values)-0.00695% CI-0.040 - 0.028p0.7259Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.01695% CI-0.018 - 0.051p0.3517Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.00595% CI-0.024 - 0.035p0.7311Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.00895% CI-0.041 - 0.026p0.6446Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.03295% CI-0.002 - 0.066p0.0640Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.01295% CI-0.017 - 0.041p0.4057Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.01595% CI-0.066 - 0.037p0.5742Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.04095% CI-0.013 - 0.093p0.1336Mixed-Effects Model Repeated Measures
Median Difference (Final Values)0.01395% CI-0.033 - 0.058p0.5734Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.01695% CI-0.104 - 0.071p0.7067Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.04295% CI-0.049 - 0.132p0.3600Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.01395% CI-0.065 - 0.090p0.7454Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-0.00695% CI-0.113 - 0.100p0.9037Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.07095% CI-0.040 - 0.181p0.2082Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.03295% CI-0.063 - 0.127p0.5044Mixed-Effects Model Repeated Measures
Fluid / digital biomarkers
4 endpointsOther/protocol endpoint
Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40
Time frame:Week 80 or Week 104
change from baseline, improvement
Other/protocol endpoint
Change From Baseline in CSF Aβ x-42
Time frame:Week 80 or Week 104
change from baseline, improvement
Other_pre_specified/registry result
Change From Baseline in Cerebrospinal Fluid (CSF) Aβ x-40
Time frame:Week 80 or Week 104
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), μg/ml | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21n=22 Participants | 192.93 | --652.96 - 1038.82 |
| ACC 10 μg+QS-21n=18 Participants | 726.74 | --252.11 - 1705.58 |
| Overall ACC + QS21n=40 Participants | 459.83 | --178.24 - 1097.91 |
| Placebon=17 Participants | 144.76 | --816.20 - 1105.71 |
Mean Difference (Final Values)48.1895% CI-1197.07 - 1293.42p0.9384ANCOVA
Analysis of Covariance (ANCOVA) was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Mean Difference (Final Values)581.9895% CI-778.17 - 1942.13p0.3945ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Mean Difference (Final Values)315.0895% CI-812.15 - 1442.30p0.5773ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Other_pre_specified/registry result
Change From Baseline in CSF Aβ x-42
Time frame:Week 80 or Week 104
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), μg/ml | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21n=22 Participants | 15.29 | --43.14 - 73.71 |
| ACC 10 μg+QS-21n=18 Participants | 75.55 | -11.89 - 139.21 |
| Overall ACC + QS21n=40 Participants | 45.42 | -1.56 - 89.28 |
| Placebon=17 Participants | -8.87 | --75.24 - 57.50 |
Mean Difference (Final Values)24.1695% CI-63.31 - 111.62p0.5818ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Mean Difference (Final Values)84.4295% CI-5.37 - 174.21p0.0648ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Mean Difference (Final Values)54.2995% CI-23.47 - 132.05p0.1672ANCOVA
ANCOVA was used with baseline assessment and ApoE4 status as covariates, in addition to treatment included in the ANCOVA model.
Caregiver / quality of life
2 endpointsOther/protocol endpoint
Change From Baseline in RUD (Abbreviated) (RUD-Lite) - Other Caregivers
Time frame:104 weeks
change from baseline, improvement
Other_pre_specified/registry result
Change From Baseline in RUD (Abbreviated) (RUD-Lite) - Other Caregivers
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), hours | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20, 20)n=22 Participants | 0.14 | --4.36 - 4.64 |
| Week 52 (N: 22, 19, 20)n=22 Participants | 0.72 | --2.66 - 4.10 |
| Week 78 (N: 22, 18, 18)n=22 Participants | 0.86 | --0.36 - 2.08 |
| Week 104 (N: 18, 18, 15)n=22 Participants | 2.13 | --9.20 - 13.47 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20, 20)n=20 Participants | 4.03 | --0.69 - 8.76 |
| Week 52 (N: 22, 19, 20)n=20 Participants | 3.03 | --0.52 - 6.59 |
| Week 78 (N: 22, 18, 18)n=20 Participants | 0.79 | --0.51 - 2.10 |
| Week 104 (N: 18, 18, 15)n=20 Participants | 1.58 | --10.12 - 13.27 |
| PlaceboWeek 26 (N: 22, 20, 20)n=21 Participants | 1.56 | --3.17 - 6.28 |
| Week 52 (N: 22, 19, 20)n=21 Participants | 0.01 | --3.54 - 3.55 |
| Week 78 (N: 22, 18, 18)n=21 Participants | 0.06 | --1.25 - 1.36 |
| Week 104 (N: 18, 18, 15)n=21 Participants | 9.64 | --2.67 - 21.96 |
Mean Difference (Final Values)-1.4295% CI-7.94 - 5.10p0.6653Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)2.4895% CI-4.20 - 9.15p0.4613Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.7295% CI-4.18 - 5.61p0.7710Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)3.0295% CI-1.99 - 8.04p0.2328Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.8095% CI-0.97 - 2.58p0.3693Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)0.7495% CI-1.09 - 2.56p0.4220Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-7.5195% CI-24.25 - 9.23p0.3728Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)-8.0795% CI-25.05 - 8.91p0.3452Mixed-Effects Model Repeated Measures
Other (unclassified)
10 endpointsOther/protocol endpoint/low confidence
Change From Baseline in Plasma Aβ x-40
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint/low confidence
Change From Baseline in Dependence Scale (DS) Score
Time frame:104 weeks
change from baseline, improvement
Other/protocol endpoint/low confidence
Geometric Mean Anti-Aβ IgG Enzyme-linked Immunosorbent Assay (ELISA) Titers
Time frame:104 weeks
descriptive
Other/protocol endpoint/low confidence
Geometric Mean Anti-Aβ IgM ELISA Titers
Time frame:104 weeks
descriptive
Other/protocol endpoint/low confidence
Alzheimer's Disease Medication Administration Concerns Questionnaire (AD MACQ)
Time frame:104 weeks
event count, event
Other_pre_specified/registry result/low confidence
Change From Baseline in Plasma Aβ x-40
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), pg/mL | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 12 (N: 22, 19, 41, 20)n=22 Participants | 30.42 | --9.80 - 70.63 |
| Week 26 (N: 22, 18, 40, 19)n=22 Participants | 150.51 | -45.32 - 255.70 |
| Week 52 (N: 22, 18, 40, 19)n=22 Participants | 252.87 | -166.03 - 339.72 |
| Week 78 (N: 22, 17, 39, 17)n=22 Participants | 225.15 | -105.18 - 345.11 |
| Week 104 (N: 18, 17, 35, 13)n=22 Participants | 216.51 | -111.67 - 321.35 |
| ACC 10 μg+QS-21Week 12 (N: 22, 19, 41, 20)n=20 Participants | 61.70 | -18.55 - 104.85 |
| Week 26 (N: 22, 18, 40, 19)n=20 Participants | 276.86 | -162.50 - 391.66 |
| Week 52 (N: 22, 18, 40, 19)n=20 Participants | 313.34 | -218.29 - 408.38 |
| Week 78 (N: 22, 17, 39, 17)n=20 Participants | 344.13 | -210.80 - 477.45 |
| Week 104 (N: 18, 17, 35, 13)n=20 Participants | 279.00 | -164.37 - 393.63 |
| Overall ACC + QS21Week 12 (N: 22, 19, 41, 20)n=42 Participants | 46.06 | -16.49 - 75.63 |
| Week 26 (N: 22, 18, 40, 19)n=42 Participants | 213.68 | -135.80 - 291.57 |
| Week 52 (N: 22, 18, 40, 19)n=42 Participants | 283.11 | -218.68 - 347.53 |
| Week 78 (N: 22, 17, 39, 17)n=42 Participants | 284.64 | -194.93 - 374.35 |
| Week 104 (N: 18, 17, 35, 13)n=42 Participants | 247.76 | -170.03 - 325.48 |
| PlaceboWeek 12 (N: 22, 19, 41, 20)n=21 Participants | 10.64 | --31.24 - 52.52 |
| Week 26 (N: 22, 18, 40, 19)n=21 Participants | 51.22 | --61.16 - 163.60 |
| Week 52 (N: 22, 18, 40, 19)n=21 Participants | 138.74 | -45.73 - 231.75 |
| Week 78 (N: 22, 17, 39, 17)n=21 Participants | 117.31 | --13.47 - 248.08 |
| Week 104 (N: 18, 17, 35, 13)n=21 Participants | 74.60 | --42.18 - 191.37 |
Mean Difference (Final Values)19.7895% CI-37.15 - 76.71p0.4892Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)51.0695% CI-8.51 - 110.63p0.0915Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)35.4295% CI-14.88 - 85.72p0.1638Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)99.2995% CI-54.28 - 252.86p0.2006Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)225.6395% CI65.18 - 386.09p0.0067Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)162.4695% CI26.05 - 298.87p0.0204Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)114.1395% CI-12.63 - 240.89p0.0766Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)226.8295% CI40.23 - 413.41p0.0181Mixed-Effects Model Repeated Measures
Median Difference (Final Values)167.3395% CI9.03 - 325.63p0.0387Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)107.8495% CI-69.29 - 284.97p0.2277Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)226.8295% CI40.23 - 413.41p0.0181Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)167.3395% CI9.03 - 325.63p0.0387Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)141.9295% CI-14.62 - 298.45p0.0747Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)204.4095% CI41.02 - 367.79p0.0151Mixed-Effects Model Repeated Measures
Mean Difference (Final Values)173.1695% CI33.25 - 313.07p0.0161Mixed-Effects Model Repeated Measures
Other_pre_specified/registry result/low confidence
Change From Baseline in Dependence Scale (DS) Score
Time frame:104 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), score | Reported spread / bounds |
|---|---|---|
| ACC 3 μg+QS-21Week 26 (N: 22, 20 , 20)n=22 Participants | 0.1 | 1.440.20 - 1.00 |
| Week 52 (N: 22, 19 , 20)n=22 Participants | -0.2 | 1.600.53 - 1.66 |
| Week 78 (22, 18, 18)n=22 Participants | 0.2 | 1.071.04 - 2.39 |
| Week 104 (N: 18, 18,15)n=22 Participants | 0.9 | 2.211.32 - 2.97 |
| ACC 10 μg+QS-21Week 26 (N: 22, 20 , 20)n=20 Participants | -0.4 | 1.39-0.11 - 0.73 |
| Week 52 (N: 22, 19 , 20)n=20 Participants | 0.2 | 1.96-0.21 - 0.99 |
| Week 78 (22, 18, 18)n=20 Participants | 0.3 | 1.41-0.04 - 1.41 |
| Week 104 (N: 18, 18,15)n=20 Participants | 0.6 | 1.580.37 - 2.10 |
| PlaceboWeek 26 (N: 22, 20 , 20)n=21 Participants | 0.0 | 1.65-0.22 - 0.63 |
| Week 52 (N: 22, 19 , 20)n=21 Participants | 0.1 | 1.860.11 - 1.31 |
| Week 78 (22, 18, 18)n=21 Participants | -0.2 | 1.930.53 - 1.97 |
| Week 104 (N: 18, 18,15)n=21 Participants | -0.1 | 2.070.23 - 2.00 |
Other_pre_specified/registry result/low confidence
Geometric Mean Anti-Aβ IgG Enzyme-linked Immunosorbent Assay (ELISA) Titers
Time frame:104 weeks
descriptive
Posted result
| Group | Value (geometric_mean), U/ml | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Baseline (N: 21, 18, 39, 21)n=22 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (N: 20, 20, 40, 21)n=22 Participants | 61.5 | -48.5 - 78.0 |
| Week 4 (N: 21, 17, 38, 21)n=22 Participants | 59.0 | -50.3 - 69.3 |
| Week 6 (N: 22, 20, 42, 21)n=22 Participants | 1490.0 | -577.0 - 3847.9 |
| Week 10 (N:22, 20, 42, 20)n=22 Participants | 774.8 | -355.7 - 1687.7 |
| Week 12 (N: 22, 18, 40, 20)n=22 Participants | 566.4 | -270.5 - 1186.1 |
| Week 14 (N: 22, 20, 42, 20)n=22 Participants | 5997.5 | -3541.6 - 10156.5 |
| Week 20 (N: 21, 20, 41, 21)n=22 Participants | 3320.9 | -1855.9 - 5942.4 |
| Week 26 (N: 22, 19, 41, 20)n=22 Participants | 1657.0 | -967.3 - 2838.5 |
| Week 28 (N: 22, 20, 42, 20)n=22 Participants | 6482.5 | -4247.1 - 9894.5 |
| Week 34 (N: 22, 20, 42, 20)n=22 Participants | 3731.9 | -2375.7 - 5862.5 |
| Week 52 (N: 20, 18, 38, 19)n=22 Participants | 1322.6 | -800.2 - 2185.9 |
| Week 54 (N: 20, 19, 39, 19)n=22 Participants | 6787.7 | -4892.4 - 9417.2 |
| Week 60 (N: 21, 19, 40, 19)n=22 Participants | 4130.7 | -2948.4 - 5787.2 |
| Week 78 (N: 19, 14, 33, 14)n=22 Participants | 2007.1 | -1357.3 - 2967.9 |
| Week 80 (N: 19, 14, 33, 16)n=22 Participants | 8006.3 | -4636.8 - 13824.2 |
| Week 86 (N: 15, 17, 32, 14)n=22 Participants | 6584.2 | -4090.5 - 10598.3 |
| Week 104 (N: 11, 9, 20, 9)n=22 Participants | 3960.8 | -2704.6 - 5800.7 |
| ACC 10 μg+QS-21Baseline (N: 21, 18, 39, 21)n=20 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (N: 20, 20, 40, 21)n=20 Participants | 81.4 | -53.3 - 124.2 |
| Week 4 (N: 21, 17, 38, 21)n=20 Participants | 86.3 | -53.3 - 139.8 |
| Week 6 (N: 22, 20, 42, 21)n=20 Participants | 1485.3 | -570.0 - 3870.0 |
| Week 10 (N:22, 20, 42, 20)n=20 Participants | 960.3 | -453.5 - 2033.2 |
| Week 12 (N: 22, 18, 40, 20)n=20 Participants | 536.0 | -238.7 - 1204.0 |
| Week 14 (N: 22, 20, 42, 20)n=20 Participants | 2796.3 | -1414.2 - 5529.1 |
| Week 20 (N: 21, 20, 41, 21)n=20 Participants | 2172.9 | -1106.7 - 4266.3 |
| Week 26 (N: 22, 19, 41, 20)n=20 Participants | 1739.1 | -801.9 - 3771.7 |
| Week 28 (N: 22, 20, 42, 20)n=20 Participants | 4668.3 | -2371.1 - 9190.7 |
| Week 34 (N: 22, 20, 42, 20)n=20 Participants | 5329.0 | -2754.6 - 10309.3 |
| Week 52 (N: 20, 18, 38, 19)n=20 Participants | 1920.8 | -983.0 - 3753.2 |
| Week 54 (N: 20, 19, 39, 19)n=20 Participants | 12064.7 | -6642.8 - 21912.2 |
| Week 60 (N: 21, 19, 40, 19)n=20 Participants | 9665.3 | -5448.3 - 17146.1 |
| Week 78 (N: 19, 14, 33, 14)n=20 Participants | 2973.5 | -1283.4 - 6889.1 |
| Week 80 (N: 19, 14, 33, 16)n=20 Participants | 11086.8 | -6331.5 - 19413.8 |
| Week 86 (N: 15, 17, 32, 14)n=20 Participants | 10125.5 | -6528.3 - 15704.9 |
| Week 104 (N: 11, 9, 20, 9)n=20 Participants | 3513.9 | -1395.3 - 8849.1 |
| Overall ACC + QS21Baseline (N: 21, 18, 39, 21)n=42 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (N: 20, 20, 40, 21)n=42 Participants | 70.7 | -55.9 - 89.6 |
| Week 4 (N: 21, 17, 38, 21)n=42 Participants | 70.0 | -55.7 - 87.9 |
| Week 6 (N: 22, 20, 42, 21)n=42 Participants | 1487.7 | -780.5 - 2835.9 |
| Week 10 (N:22, 20, 42, 20)n=42 Participants | 858.1 | -510.3 - 1443.1 |
| Week 12 (N: 22, 18, 40, 20)n=42 Participants | 552.5 | -328.2 - 930.1 |
| Week 14 (N: 22, 20, 42, 20)n=42 Participants | 4170.3 | -2727.9 - 6375.2 |
| Week 20 (N: 21, 20, 41, 21)n=42 Participants | 2700.2 | -1757.7 - 4148.2 |
| Week 26 (N: 22, 19, 41, 20)n=42 Participants | 1694.6 | -1092.4 - 2628.8 |
| Week 28 (N: 22, 20, 42, 20)n=42 Participants | 5544.3 | -3802.5 - 8083.7 |
| Week 34 (N: 22, 20, 42, 20)n=42 Participants | 4421.9 | -3024.7 - 6464.5 |
| Week 52 (N: 20, 18, 38, 19)n=42 Participants | 1578.3 | -1060.8 - 2348.2 |
| Week 54 (N: 20, 19, 39, 19)n=42 Participants | 8982.9 | -6438.2 - 12533.3 |
| Week 60 (N: 21, 19, 40, 19)n=42 Participants | 6185.7 | -4410.2 - 8676.0 |
| Week 78 (N: 19, 14, 33, 14)n=42 Participants | 2371.3 | -1590.2 - 3536.0 |
| Week 80 (N: 19, 14, 33, 16)n=42 Participants | 9192.0 | -6303.8 - 13403.4 |
| Week 86 (N: 15, 17, 32, 14)n=42 Participants | 8275.6 | -6046.9 - 11325.9 |
| Week 104 (N: 11, 9, 20, 9)n=42 Participants | 3753.1 | -2481.5 - 5676.2 |
| PlaceboBaseline (N: 21, 18, 39, 21)n=21 Participants | 53.5 | -46.5 - 61.6 |
| Week 2 (N: 20, 20, 40, 21)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 4 (N: 21, 17, 38, 21)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 6 (N: 22, 20, 42, 21)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 10 (N:22, 20, 42, 20)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 12 (N: 22, 18, 40, 20)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 14 (N: 22, 20, 42, 20)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 20 (N: 21, 20, 41, 21)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 26 (N: 22, 19, 41, 20)n=21 Participants | 60.7 | -40.5 - 90.9 |
| Week 28 (N: 22, 20, 42, 20)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 34 (N: 22, 20, 42, 20)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 52 (N: 20, 18, 38, 19)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 54 (N: 20, 19, 39, 19)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 60 (N: 21, 19, 40, 19)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 78 (N: 19, 14, 33, 14)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 80 (N: 19, 14, 33, 16)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 86 (N: 15, 17, 32, 14)n=21 Participants | 50.0 | -50.0 - 50.0 |
| Week 104 (N: 11, 9, 20, 9)n=21 Participants | 50.0 | -50.0 - 50.0 |
Other_pre_specified/registry result/low confidence
Geometric Mean Anti-Aβ IgM ELISA Titers
Time frame:104 weeks
descriptive
Posted result
| Group | Value (geometric_mean), U/ml | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Baseline (N: 21, 18, 39, 21)n=22 Participants | 31.8 | -25.0 - 40.4 |
| Week 2 (N: 20, 20, 40, 21)n=22 Participants | 69.7 | -37.9 - 128.1 |
| Week 4 (N: 21, 17, 38, 21)n=22 Participants | 75.0 | -41.5 - 135.6 |
| Week 6 (N: 22, 20, 42, 21)n=22 Participants | 840.8 | -387.9 - 1822.8 |
| Week 10 (N:22, 20, 42, 20)n=22 Participants | 723.6 | -318.9 - 1641.8 |
| Week 12 (N: 22, 18, 40, 19)n=22 Participants | 604.2 | -277.5 - 1315.6 |
| Week 14 (N: 22, 20, 42, 20)n=22 Participants | 1232.4 | -632.4 - 2401.8 |
| Week 20 (N: 21, 20, 41, 21)n=22 Participants | 1060.2 | -505.2 - 2224.8 |
| Week 26 (N: 22, 19, 41, 20)n=22 Participants | 684.8 | -361.8 - 1296.3 |
| Week 28 (N: 22, 20, 42, 20)n=22 Participants | 1241.6 | -685.5 - 2248.7 |
| Week 34 (N: 22, 20, 42, 20)n=22 Participants | 953.6 | -519.4 - 1750.8 |
| Week 52 (N: 20, 18, 38, 19)n=22 Participants | 493.8 | -269.2 - 905.8 |
| Week 54 (N: 20, 19, 39, 19)n=22 Participants | 776.5 | -426.1 - 1415.0 |
| Week 60 (N: 21, 19, 40, 19)n=22 Participants | 782.2 | -409.2 - 1495.2 |
| Week 78 (N: 19, 14, 33, 14)n=22 Participants | 635.3 | -306.2 - 1318.2 |
| Week 80 (N: 19, 14, 33, 16)n=22 Participants | 744.8 | -376.0 - 1475.0 |
| Week 86 (N: 15, 17, 32, 14)n=22 Participants | 768.1 | -278.7 - 2117.0 |
| Week 104 (N: 11, 9, 20, 9)n=22 Participants | 602.7 | -221.2 - 1642.1 |
| ACC 10 μg+QS-21Baseline (N: 21, 18, 39, 21)n=20 Participants | 33.9 | -23.6 - 48.8 |
| Week 2 (N: 20, 20, 40, 21)n=20 Participants | 121.0 | -66.1 - 221.6 |
| Week 4 (N: 21, 17, 38, 21)n=20 Participants | 141.3 | -72.8 - 274.0 |
| Week 6 (N: 22, 20, 42, 21)n=20 Participants | 975.8 | -482.0 - 1975.8 |
| Week 10 (N:22, 20, 42, 20)n=20 Participants | 967.3 | -397.4 - 2354.6 |
| Week 12 (N: 22, 18, 40, 19)n=20 Participants | 611.5 | -255.3 - 1464.6 |
| Week 14 (N: 22, 20, 42, 20)n=20 Participants | 1194.6 | -502.6 - 2839.0 |
| Week 20 (N: 21, 20, 41, 21)n=20 Participants | 1070.5 | -456.7 - 2509.4 |
| Week 26 (N: 22, 19, 41, 20)n=20 Participants | 939.4 | -414.8 - 2127.4 |
| Week 28 (N: 22, 20, 42, 20)n=20 Participants | 1117.1 | -497.8 - 2506.7 |
| Week 34 (N: 22, 20, 42, 20)n=20 Participants | 1084.5 | -456.8 - 2574.7 |
| Week 52 (N: 20, 18, 38, 19)n=20 Participants | 522.9 | -211.7 - 1291.4 |
| Week 54 (N: 20, 19, 39, 19)n=20 Participants | 1176.0 | -495.4 - 2791.3 |
| Week 60 (N: 21, 19, 40, 19)n=20 Participants | 1228.4 | -471.9 - 3197.6 |
| Week 78 (N: 19, 14, 33, 14)n=20 Participants | 321.4 | -111.1 - 929.4 |
| Week 80 (N: 19, 14, 33, 16)n=20 Participants | 677.0 | -213.5 - 2174.2 |
| Week 86 (N: 15, 17, 32, 14)n=20 Participants | 1023.7 | -361.0 - 2903.0 |
| Week 104 (N: 11, 9, 20, 9)n=20 Participants | 287.8 | -65.1 - 1271.9 |
| Overall ACC + QS21Baseline (N: 21, 18, 39, 21)n=42 Participants | 32.7 | -26.8 - 40.1 |
| Week 2 (N: 20, 20, 40, 21)n=42 Participants | 91.8 | -60.4 - 139.6 |
| Week 4 (N: 21, 17, 38, 21)n=42 Participants | 99.6 | -64.6 - 153.5 |
| Week 6 (N: 22, 20, 42, 21)n=42 Participants | 902.6 | -545.1 - 1494.5 |
| Week 10 (N:22, 20, 42, 20)n=42 Participants | 830.8 | -465.9 - 1481.5 |
| Week 12 (N: 22, 18, 40, 19)n=42 Participants | 607.5 | -349.0 - 1057.4 |
| Week 14 (N: 22, 20, 42, 20)n=42 Participants | 1214.2 | -724.5 - 2035.0 |
| Week 20 (N: 21, 20, 41, 21)n=42 Participants | 1065.2 | -622.3 - 1823.3 |
| Week 26 (N: 22, 19, 41, 20)n=42 Participants | 792.9 | -485.9 - 1293.8 |
| Week 28 (N: 22, 20, 42, 20)n=42 Participants | 1180.6 | -735.7 - 1894.8 |
| Week 34 (N: 22, 20, 42, 20)n=42 Participants | 1013.9 | -616.6 - 1667.2 |
| Week 52 (N: 20, 18, 38, 19)n=42 Participants | 507.4 | -305.5 - 842.7 |
| Week 54 (N: 20, 19, 39, 19)n=42 Participants | 950.5 | -575.9 - 1568.9 |
| Week 60 (N: 21, 19, 40, 19)n=42 Participants | 969.2 | -561.7 - 1672.4 |
| Week 78 (N: 19, 14, 33, 14)n=42 Participants | 475.8 | -263.4 - 859.5 |
| Week 80 (N: 19, 14, 33, 16)n=42 Participants | 715.2 | -397.0 - 1288.6 |
| Week 86 (N: 15, 17, 32, 14)n=42 Participants | 894.7 | -449.0 - 1782.7 |
| Week 104 (N: 11, 9, 20, 9)n=42 Participants | 432.2 | -195.1 - 957.3 |
| PlaceboBaseline (N: 21, 18, 39, 21)n=21 Participants | 31.6 | -26.0 - 38.4 |
| Week 2 (N: 20, 20, 40, 21)n=21 Participants | 30.2 | -25.1 - 36.3 |
| Week 4 (N: 21, 17, 38, 21)n=21 Participants | 31.0 | -25.8 - 37.1 |
| Week 6 (N: 22, 20, 42, 21)n=21 Participants | 31.5 | -26.0 - 38.3 |
| Week 10 (N:22, 20, 42, 20)n=21 Participants | 32.1 | -25.8 - 39.9 |
| Week 12 (N: 22, 18, 40, 19)n=21 Participants | 32.6 | -26.1 - 40.6 |
| Week 14 (N: 22, 20, 42, 20)n=21 Participants | 32.6 | -26.0 - 40.8 |
| Week 20 (N: 21, 20, 41, 21)n=21 Participants | 31.6 | -25.9 - 38.5 |
| Week 26 (N: 22, 19, 41, 20)n=21 Participants | 32.6 | -26.1 - 40.9 |
| Week 28 (N: 22, 20, 42, 20)n=21 Participants | 31.9 | -25.9 - 39.2 |
| Week 34 (N: 22, 20, 42, 20)n=21 Participants | 32.0 | -25.9 - 39.5 |
| Week 52 (N: 20, 18, 38, 19)n=21 Participants | 29.2 | -24.3 - 35.0 |
| Week 54 (N: 20, 19, 39, 19)n=21 Participants | 29.8 | -24.2 - 36.6 |
| Week 60 (N: 21, 19, 40, 19)n=21 Participants | 31.0 | -24.9 - 38.7 |
| Week 78 (N: 19, 14, 33, 14)n=21 Participants | 28.5 | -23.5 - 34.5 |
| Week 80 (N: 19, 14, 33, 16)n=21 Participants | 30.7 | -23.9 - 39.3 |
| Week 86 (N: 15, 17, 32, 14)n=21 Participants | 32.2 | -23.7 - 43.7 |
| Week 104 (N: 11, 9, 20, 9)n=21 Participants | 29.2 | -20.4 - 41.9 |
Other_pre_specified/registry result/low confidence
Alzheimer's Disease Medication Administration Concerns Questionnaire (AD MACQ)
Time frame:104 weeks
event count, event
Posted result
| Group | Value (number), percentage of participants | Reported bounds |
|---|---|---|
| ACC 3 μg+QS-21Question a: Agreen=22 Participants | 40.9 | - |
| Question a: Slightly Agreen=22 Participants | 13.6 | - |
| Question a: Neither Agree Nor Disagreen=22 Participants | 13.6 | - |
| Question a: Slightly Disagreen=22 Participants | 9.1 | - |
| Question a: Disagreen=22 Participants | 22.7 | - |
| Question b: Agreen=22 Participants | 68.2 | - |
| Question b: Slightly Agreen=22 Participants | 9.1 | - |
| Question b: Neither Agree Nor Disagreen=22 Participants | 22.7 | - |
| Question b: Slightly Disagreen=22 Participants | 0 | - |
| Question b: Disagreen=22 Participants | 0 | - |
| Question c: Agreen=22 Participants | 4.5 | - |
| Question c: Slightly Agreen=22 Participants | 13.6 | - |
| Question c: Neither Agree Nor Disagreen=22 Participants | 22.7 | - |
| Question c: Slightly Disagreen=22 Participants | 4.5 | - |
| Question c: Disagreen=22 Participants | 54.5 | - |
| Question d: Agreen=22 Participants | 27.3 | - |
| Question d: Slightly Agreen=22 Participants | 4.5 | - |
| Question d: Neither Agree Nor Disagreen=22 Participants | 40.9 | - |
| Question d: Slightly Disagreen=22 Participants | 0 | - |
| Question d: Disagreen=22 Participants | 27.3 | - |
| Question e: Agreen=22 Participants | 63.6 | - |
| Question e: Slightly Agreen=22 Participants | 13.6 | - |
| Question e: Neither Agree Nor Disagreen=22 Participants | 22.7 | - |
| Question e: Slightly Disagreen=22 Participants | 0 | - |
| Question e: Disagreen=22 Participants | 0 | - |
| ACC 10 μg+QS-21Question a: Agreen=19 Participants | 42.1 | - |
| Question a: Slightly Agreen=19 Participants | 0 | - |
| Question a: Neither Agree Nor Disagreen=19 Participants | 21.1 | - |
| Question a: Slightly Disagreen=19 Participants | 0 | - |
| Question a: Disagreen=19 Participants | 36.8 | - |
| Question b: Agreen=19 Participants | 68.4 | - |
| Question b: Slightly Agreen=19 Participants | 10.5 | - |
| Question b: Neither Agree Nor Disagreen=19 Participants | 21.1 | - |
| Question b: Slightly Disagreen=19 Participants | 0 | - |
| Question b: Disagreen=19 Participants | 0 | - |
| Question c: Agreen=19 Participants | 26.3 | - |
| Question c: Slightly Agreen=19 Participants | 5.3 | - |
| Question c: Neither Agree Nor Disagreen=19 Participants | 26.3 | - |
| Question c: Slightly Disagreen=19 Participants | 0 | - |
| Question c: Disagreen=19 Participants | 42.1 | - |
| Question d: Agreen=19 Participants | 21.1 | - |
| Question d: Slightly Agreen=19 Participants | 10.5 | - |
| Question d: Neither Agree Nor Disagreen=19 Participants | 31.6 | - |
| Question d: Slightly Disagreen=19 Participants | 5.3 | - |
| Question d: Disagreen=19 Participants | 31.6 | - |
| Question e: Agreen=19 Participants | 84.2 | - |
| Question e: Slightly Agreen=19 Participants | 0 | - |
| Question e: Neither Agree Nor Disagreen=19 Participants | 15.8 | - |
| Question e: Slightly Disagreen=19 Participants | 0 | - |
| Question e: Disagreen=19 Participants | 0 | - |
| PlaceboQuestion a: Agreen=20 Participants | 25 | - |
| Question a: Slightly Agreen=20 Participants | 0 | - |
| Question a: Neither Agree Nor Disagreen=20 Participants | 0 | - |
| Question a: Slightly Disagreen=20 Participants | 10 | - |
| Question a: Disagreen=20 Participants | 65 | - |
| Question b: Agreen=20 Participants | 70 | - |
| Question b: Slightly Agreen=20 Participants | 15 | - |
| Question b: Neither Agree Nor Disagreen=20 Participants | 15 | - |
| Question b: Slightly Disagreen=20 Participants | 0 | - |
| Question b: Disagreen=20 Participants | 0 | - |
| Question c: Agreen=20 Participants | 20 | - |
| Question c: Slightly Agreen=20 Participants | 0 | - |
| Question c: Neither Agree Nor Disagreen=20 Participants | 10 | - |
| Question c: Slightly Disagreen=20 Participants | 10 | - |
| Question c: Disagreen=20 Participants | 60 | - |
| Question d: Agreen=20 Participants | 20 | - |
| Question d: Slightly Agreen=20 Participants | 0 | - |
| Question d: Neither Agree Nor Disagreen=20 Participants | 25 | - |
| Question d: Slightly Disagreen=20 Participants | 15 | - |
| Question d: Disagreen=20 Participants | 40 | - |
| Question e: Agreen=20 Participants | 80 | - |
| Question e: Slightly Agreen=20 Participants | 5 | - |
| Question e: Neither Agree Nor Disagreen=20 Participants | 15 | - |
| Question e: Slightly Disagreen=20 Participants | 0 | - |
| Question e: Disagreen=20 Participants | 0 | - |
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID29210443via DERIVED
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.