← Trials/Trial dossier/NCT00959192
CompletedPhase 2Results posted
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 Withqs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.
Lead sponsor
Asset
ACC-001
Listed sites
9
Recruiting sites
-
Enrollment
32
actual
Study population
Alzheimer’s disease
Key I/E criteria
•mild-to-moderate AD•MMSE 16-26
Primary endpoints
•Treatment-emergent Adverse Events (AEs) by Severity•Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data•Abnormalities in Neurological Examination
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
Org study ID3134K1-2206
Secondary IDB2571009Alias Study Number
NCT IDNCT00959192
Timeline
Milestones
Study start2009-08 (month precision)
Study first posted2009-08-14estimated
Primary completion2013-01actual (month precision)
Study completion2013-01actual (month precision)
Last update posted2016-01-01estimated
Results first posted2016-01-01estimated
Assets
Drug assets
Study populations
Who this study enrolls
Alzheimer’s disease
Eligibility
Who can enroll
Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted
Inclusion criteria
•Diagnosis of mild to moderate Alzheimer's Disease
•Mini-Mental State Examination (MMSE) 16-26
Exclusion criteria
•Significant Neurological Disease other than Alzheimer's disease
•Major psychiatric disorder
•Clinically significant systemic illness
Endpoints (18)
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
Global cognition
6
Other (unclassified)
4
Executive function / language
2
Function / daily living
2
Neuroimaging
2
Safety / tolerability / PK
2
Global cognition
6 endpointsOther/protocol endpoint
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
Time frame:Baseline up to 24 months
ADAS-Cog
concentration, descriptive
Other/protocol endpoint
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
Time frame:Baseline up to 24 months
categorical status, descriptive
Other/protocol endpoint
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Time frame:Baseline up to 24 months
Mini-Mental State Examination (MMSE)
descriptive
Other_pre_specified/registry result
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
Time frame:Baseline up to 24 months
ADAS-Cog
concentration, descriptive
Posted result
| Group | Value (mean), Units on a scale | Standard deviation |
|---|---|---|
| ACC-001 3 Micrograms + QS-21Week 12 (n=6,9,9,8)n=6 Participants | 0.06 | 5.20 |
| Week 26 (n=6,9,9,8)n=6 Participants | 0.39 | 4.38 |
| Week 52 (n=5,9,7,8)n=6 Participants | 1.87 | 8.32 |
| Week 78 (n=4,8,6,7)n=6 Participants | 0.17 | 3.50 |
| Week 104 (n=0,1,1,0)n=6 Participants | NA | NA |
| ACC-001 10 Micrograms + QS-21Week 12 (n=6,9,9,8)n=9 Participants | 0.52 | 4.39 |
| Week 26 (n=6,9,9,8)n=9 Participants | -0.41 | 5.41 |
| Week 52 (n=5,9,7,8)n=9 Participants | 0.15 | 4.82 |
| Week 78 (n=4,8,6,7)n=9 Participants | 3.40 | 7.08 |
| Week 104 (n=0,1,1,0)n=9 Participants | -4.33 | NA |
| ACC-001 30 Micrograms + QS-21Week 12 (n=6,9,9,8)n=9 Participants | 2.93 | 4.10 |
| Week 26 (n=6,9,9,8)n=9 Participants | 3.56 | 6.74 |
| Week 52 (n=5,9,7,8)n=9 Participants | 5.05 | 6.68 |
| Week 78 (n=4,8,6,7)n=9 Participants | 5.39 | 3.66 |
| Week 104 (n=0,1,1,0)n=9 Participants | 8.33 | NA |
| QS-21Week 12 (n=6,9,9,8)n=8 Participants | -0.25 | 3.30 |
| Week 26 (n=6,9,9,8)n=8 Participants | -0.63 | 5.76 |
| Week 52 (n=5,9,7,8)n=8 Participants | 1.04 | 7.01 |
| Week 78 (n=4,8,6,7)n=8 Participants | 2.33 | 7.78 |
| Week 104 (n=0,1,1,0)n=8 Participants | NA | NA |
Other_pre_specified/registry result
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
Time frame:Baseline up to 24 months
categorical status, descriptive
Posted result
| Group | Value (mean), Z-score | Standard deviation |
|---|---|---|
| ACC-001 3 Micrograms + QS-21Week 12 (n=6,9,8,8)n=6 Participants | 0.023 | 0.416 |
| Week 26 (n=6,9,9,8)n=6 Participants | 0.114 | 0.423 |
| Week 52 (n=5,9,7,8)n=6 Participants | 0.081 | 0.288 |
| Week 78 (n=4,8,6,7)n=6 Participants | -0.088 | 0.334 |
| Week 104 (n=0,1,1,0)n=6 Participants | NA | NA |
| ACC-001 10 Micrograms + QS-21Week 12 (n=6,9,8,8)n=9 Participants | 0.275 | 0.280 |
| Week 26 (n=6,9,9,8)n=9 Participants | 0.254 | 0.353 |
| Week 52 (n=5,9,7,8)n=9 Participants | 0.211 | 0.285 |
| Week 78 (n=4,8,6,7)n=9 Participants | -0.037 | 0.494 |
| Week 104 (n=0,1,1,0)n=9 Participants | 0.514 | NA |
| ACC-001 30 Micrograms + QS-21Week 12 (n=6,9,8,8)n=9 Participants | -0.028 | 0.282 |
| Week 26 (n=6,9,9,8)n=9 Participants | -0.081 | 0.530 |
| Week 52 (n=5,9,7,8)n=9 Participants | -0.109 | 0.263 |
| Week 78 (n=4,8,6,7)n=9 Participants | -0.120 | 0.442 |
| Week 104 (n=0,1,1,0)n=9 Participants | -0.559 | NA |
| QS-21Week 12 (n=6,9,8,8)n=8 Participants | 0.227 | 0.107 |
| Week 26 (n=6,9,9,8)n=8 Participants | 0.222 | 0.308 |
| Week 52 (n=5,9,7,8)n=8 Participants | 0.213 | 0.416 |
| Week 78 (n=4,8,6,7)n=8 Participants | 0.246 | 0.336 |
| Week 104 (n=0,1,1,0)n=8 Participants | NA | NA |
Other_pre_specified/registry result
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Time frame:Baseline up to 24 months
Mini-Mental State Examination (MMSE)
descriptive
Posted result
| Group | Value (mean), Units on a scale | Standard deviation |
|---|---|---|
| ACC-001 3 Micrograms + QS-21Week 4 (n=6,9,9,8)n=6 Participants | 1.7 | 1.5 |
| Week 8 (n=6,9,9,8)n=6 Participants | 2.2 | 3.1 |
| Week 12 (n=6,9,9,8)n=6 Participants | 0.8 | 2.8 |
| Week 16 (n=6,9,9,8)n=6 Participants | 1.5 | 3.4 |
| Week 26 (n=6,9,8,8)n=6 Participants | 0.3 | 3.8 |
| Week 30 (n=6,9,8,8)n=6 Participants | 0.3 | 3.7 |
| Week 40 (n=4,9,7,8)n=6 Participants | 2.3 | 2.2 |
| Week 52 (n=5,8,7,7)n=6 Participants | 0.4 | 4.5 |
| Week 78 (n=4,8,6,7)n=6 Participants | 1.8 | 2.5 |
| Week 104 (n=0,1,1,0)n=6 Participants | NA | NA |
| ACC-001 10 Micrograms + QS-21Week 4 (n=6,9,9,8)n=9 Participants | 1.3 | 1.7 |
| Week 8 (n=6,9,9,8)n=9 Participants | 0.9 | 3.2 |
| Week 12 (n=6,9,9,8)n=9 Participants | 1.1 | 2.7 |
| Week 16 (n=6,9,9,8)n=9 Participants | 1.3 | 2.3 |
| Week 26 (n=6,9,8,8)n=9 Participants | 0.1 | 2.6 |
| Week 30 (n=6,9,8,8)n=9 Participants | 1.2 | 2.4 |
| Week 40 (n=4,9,7,8)n=9 Participants | 0.8 | 3.5 |
| Week 52 (n=5,8,7,7)n=9 Participants | 1.0 | 3.8 |
| Week 78 (n=4,8,6,7)n=9 Participants | -1.4 | 3.9 |
| Week 104 (n=0,1,1,0)n=9 Participants | -2.0 | NA |
| ACC-001 30 Micrograms + QS-21Week 4 (n=6,9,9,8)n=9 Participants | 1.6 | 2.7 |
| Week 8 (n=6,9,9,8)n=9 Participants | 1.3 | 1.7 |
| Week 12 (n=6,9,9,8)n=9 Participants | 1.1 | 2.0 |
| Week 16 (n=6,9,9,8)n=9 Participants | 2.9 | 2.5 |
| Week 26 (n=6,9,8,8)n=9 Participants | 1.0 | 2.8 |
| Week 30 (n=6,9,8,8)n=9 Participants | 1.6 | 2.4 |
| Week 40 (n=4,9,7,8)n=9 Participants | 0.7 | 2.0 |
| Week 52 (n=5,8,7,7)n=9 Participants | 1.1 | 2.1 |
| Week 78 (n=4,8,6,7)n=9 Participants | -0.3 | 1.2 |
| Week 104 (n=0,1,1,0)n=9 Participants | -1.0 | NA |
| QS-21Week 4 (n=6,9,9,8)n=8 Participants | 0.4 | 2.3 |
| Week 8 (n=6,9,9,8)n=8 Participants | 0.9 | 2.6 |
| Week 12 (n=6,9,9,8)n=8 Participants | 1.4 | 2.7 |
| Week 16 (n=6,9,9,8)n=8 Participants | 0.4 | 1.8 |
| Week 26 (n=6,9,8,8)n=8 Participants | -0.1 | 1.6 |
| Week 30 (n=6,9,8,8)n=8 Participants | 0.3 | 3.3 |
| Week 40 (n=4,9,7,8)n=8 Participants | 0.5 | 3.2 |
| Week 52 (n=5,8,7,7)n=8 Participants | 0.6 | 2.5 |
| Week 78 (n=4,8,6,7)n=8 Participants | 0.0 | 3.2 |
| Week 104 (n=0,1,1,0)n=8 Participants | NA | NA |
Executive function / language
2 endpointsPrimary/protocol endpoint
Number of Participants With Abnormalities in Neurological Examination
Time frame:Baseline up to 24 months
event count, event
Primary/registry result
Number of Participants With Abnormalities in Neurological Examination
Time frame:Baseline up to 24 months
event count, event
Posted result
| Group | Value (number), Participants | Reported bounds |
|---|---|---|
| ACC-001 3 Micrograms + QS-21Totaln=6 Participants | 1 | - |
| Mental Statusn=6 Participants | 0 | - |
| Speechn=6 Participants | 0 | - |
| Cranial Nervesn=6 Participants | 0 | - |
| Visual Fieldn=6 Participants | 0 | - |
| Sensoryn=6 Participants | 1 | - |
| Motorn=6 Participants | 0 | - |
| Coordinationn=6 Participants | 0 | - |
| Gaten=6 Participants | 0 | - |
| Primitive reflexesn=6 Participants | 0 | - |
| Tendon reflexesn=6 Participants | 0 | - |
| Rombergn=6 Participants | 0 | - |
| ACC-001 10 Micrograms + QS-21Totaln=9 Participants | 1 | - |
| Mental Statusn=9 Participants | 0 | - |
| Speechn=9 Participants | 0 | - |
| Cranial Nervesn=9 Participants | 0 | - |
| Visual Fieldn=9 Participants | 0 | - |
| Sensoryn=9 Participants | 0 | - |
| Motorn=9 Participants | 0 | - |
| Coordinationn=9 Participants | 0 | - |
| Gaten=9 Participants | 0 | - |
| Primitive reflexesn=9 Participants | 0 | - |
| Tendon reflexesn=9 Participants | 0 | - |
| Rombergn=9 Participants | 1 | - |
| ACC-001 30 Micrograms + QS-21Totaln=9 Participants | 0 | - |
| Mental Statusn=9 Participants | 0 | - |
| Speechn=9 Participants | 0 | - |
| Cranial Nervesn=9 Participants | 0 | - |
| Visual Fieldn=9 Participants | 0 | - |
| Sensoryn=9 Participants | 0 | - |
| Motorn=9 Participants | 0 | - |
| Coordinationn=9 Participants | 0 | - |
| Gaten=9 Participants | 0 | - |
| Primitive reflexesn=9 Participants | 0 | - |
| Tendon reflexesn=9 Participants | 0 | - |
| Rombergn=9 Participants | 0 | - |
| QS-21Totaln=8 Participants | 0 | - |
| Mental Statusn=8 Participants | 0 | - |
| Speechn=8 Participants | 0 | - |
| Cranial Nervesn=8 Participants | 0 | - |
| Visual Fieldn=8 Participants | 0 | - |
| Sensoryn=8 Participants | 0 | - |
| Motorn=8 Participants | 0 | - |
| Coordinationn=8 Participants | 0 | - |
| Gaten=8 Participants | 0 | - |
| Primitive reflexesn=8 Participants | 0 | - |
| Tendon reflexesn=8 Participants | 0 | - |
| Rombergn=8 Participants | 0 | - |
Function / daily living
2 endpointsOther/protocol endpoint
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
Time frame:Baseline up to 24 months
descriptive
Other_pre_specified/registry result
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
Time frame:Baseline up to 24 months
descriptive
Posted result
| Group | Value (mean), Units on a scale | Standard deviation |
|---|---|---|
| ACC-001 3 Micrograms + QS-21Week 12 (n=5,9,7,8)n=6 Participants | -4.7 | 9.7 |
| Week 26 (n=6,9,8,8)n=6 Participants | -10.1 | 14.5 |
| Week 52 (n=5,8,6,8)n=6 Participants | -11.2 | 20.9 |
| Week 78 (n=4,8,5,6)n=6 Participants | -0.6 | 3.1 |
| Week 104 (n=0,1,1,0)n=6 Participants | NA | NA |
| ACC-001 10 Micrograms + QS-21Week 12 (n=5,9,7,8)n=9 Participants | 0.7 | 2.6 |
| Week 26 (n=6,9,8,8)n=9 Participants | -0.2 | 11.9 |
| Week 52 (n=5,8,6,8)n=9 Participants | -3.4 | 10.7 |
| Week 78 (n=4,8,5,6)n=9 Participants | -5.4 | 7.7 |
| Week 104 (n=0,1,1,0)n=9 Participants | 0 | NA |
| ACC-001 30 Micrograms + QS-21Week 12 (n=5,9,7,8)n=8 Participants | 1.5 | 5.1 |
| Week 26 (n=6,9,8,8)n=8 Participants | -4.4 | 28.6 |
| Week 52 (n=5,8,6,8)n=8 Participants | -1.8 | 5.1 |
| Week 78 (n=4,8,5,6)n=8 Participants | 0.5 | 6.9 |
| Week 104 (n=0,1,1,0)n=8 Participants | 12.8 | NA |
| QS-21Week 12 (n=5,9,7,8)n=8 Participants | 1.7 | 6.4 |
| Week 26 (n=6,9,8,8)n=8 Participants | -0.6 | 6.5 |
| Week 52 (n=5,8,6,8)n=8 Participants | -3.1 | 9.0 |
| Week 78 (n=4,8,5,6)n=8 Participants | 3.5 | 3.2 |
| Week 104 (n=0,1,1,0)n=8 Participants | NA | NA |
Neuroimaging
2 endpointsPrimary/protocol endpoint
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Time frame:Baseline up to 24 months
event count, event
Primary/registry result
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Time frame:Baseline up to 24 months
event count, event
Posted result
| Group | Value (number), Participants | Reported bounds |
|---|---|---|
| ACC-001 3 Micrograms + QS-21Abnormal - inconsistent with ADn=6 Participants | 1 | - |
| Abnormal - consistent with ADn=6 Participants | 6 | - |
| ACC-001 10 Micrograms + QS-21Abnormal - inconsistent with ADn=9 Participants | 0 | - |
| Abnormal - consistent with ADn=9 Participants | 9 | - |
| ACC-001 30 Micrograms + QS-21Abnormal - inconsistent with ADn=9 Participants | 2 | - |
| Abnormal - consistent with ADn=9 Participants | 9 | - |
| QS-21Abnormal - inconsistent with ADn=8 Participants | 0 | - |
| Abnormal - consistent with ADn=8 Participants | 8 | - |
Safety / tolerability / PK
2 endpointsPrimary/protocol endpoint
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Time frame:Baseline up to 24 months
event count, event
Primary/registry result
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Time frame:Baseline up to 24 months
event count, event
Posted result
| Group | Value (number), Participants | Reported bounds |
|---|---|---|
| ACC-001 3 Micrograms + QS-21Mildn=6 Participants | 4 | - |
| Moderaten=6 Participants | 2 | - |
| Severen=6 Participants | 0 | - |
| ACC-001 10 Micrograms + QS-21Mildn=9 Participants | 7 | - |
| Moderaten=9 Participants | 1 | - |
| Severen=9 Participants | 0 | - |
| ACC-001 30 Micrograms + QS-21Mildn=9 Participants | 7 | - |
| Moderaten=9 Participants | 1 | - |
| Severen=9 Participants | 1 | - |
| QS-21Mildn=8 Participants | 5 | - |
| Moderaten=8 Participants | 2 | - |
| Severen=8 Participants | 0 | - |
Other (unclassified)
4 endpointsSecondary/protocol endpoint/low confidence
Anti-a-beta IgG Titer at Specified Visits
Time frame:Baseline up to 24 months
descriptive
Secondary/protocol endpoint/low confidence
Anti-a-beta IgM Titer at Specified Visits
Time frame:Baseline up to 24 months
descriptive
Secondary/registry result/low confidence
Anti-a-beta IgG Titer at Specified Visits
Time frame:Baseline up to 24 months
descriptive
Posted result
| Group | Value (geometric_mean), Units/mL | Reported bounds |
|---|---|---|
| ACC-001 3 Micrograms + QS-21Pre-study (n=6,9,9,8)n=6 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=6,9,9,8)n=6 Participants | 62.2 | -35.5 - 109.3 |
| Week 4 (n=6,9,9,8)n=6 Participants | 107.9 | -30.3 - 384.4 |
| Week 6 (n=6,9,9,8)n=6 Participants | 2106.5 | -141.7 - 31312.7 |
| Week 8 (n=6,9,9,8)n=6 Participants | 1143.3 | -108.0 - 12104.3 |
| Week 10 (n=6,9,9,8)n=6 Participants | 979.2 | -96.8 - 9903.1 |
| Week 14 (n=6,9,9,8)n=6 Participants | 6088.4 | -714.5 - 51878.2 |
| Week 16 (n=6,9,9,8)n=6 Participants | 3860.4 | -342.5 - 43507.1 |
| Week 24 (n=6,9,9,8)n=6 Participants | 1151.5 | -165.8 - 7998.4 |
| Week 28 (n=6,9,7,8)n=6 Participants | 8216.5 | -1550.5 - 43541.2 |
| Week 30 (n=6,9,7,8)n=6 Participants | 7218.7 | -1438.9 - 36213.5 |
| Week 40 (n=5,9,8,8)n=6 Participants | 3136.4 | -651.2 - 15106.7 |
| Week 50 (n=6,8,7,8)n=6 Participants | 1854.5 | -558.3 - 6159.4 |
| Week 54 (n=5,8,7,7)n=6 Participants | 2873.6 | -264.8 - 31178.1 |
| Week 56 (n=4,8,7,7)n=6 Participants | 11006.2 | -1617.8 - 74878.3 |
| Week 66 (n=4,8,7,7)n=6 Participants | 7407.9 | -1127.0 - 48693.5 |
| Week 78 (n=4,8,6,7)n=6 Participants | 5108.6 | -1013.9 - 25739.1 |
| Week 91 (n=0,1,1,0)n=6 Participants | NA | -NA - NA |
| Week 104 (n=0,1,1,0)n=6 Participants | NA | -NA - NA |
| ACC-001 10 Micrograms + QS-21Pre-study (n=6,9,9,8)n=9 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=6,9,9,8)n=9 Participants | 65.0 | -35.5 - 118.9 |
| Week 4 (n=6,9,9,8)n=9 Participants | 94.2 | -40.1 - 221.1 |
| Week 6 (n=6,9,9,8)n=9 Participants | 4793.2 | -1261.0 - 18220.0 |
| Week 8 (n=6,9,9,8)n=9 Participants | 2331.4 | -512.2 - 10612.3 |
| Week 10 (n=6,9,9,8)n=9 Participants | 1674.9 | -369.5 - 7592.9 |
| Week 14 (n=6,9,9,8)n=9 Participants | 6286.2 | -3923.5 - 10071.6 |
| Week 16 (n=6,9,9,8)n=9 Participants | 4170.4 | -2641.8 - 6583.4 |
| Week 24 (n=6,9,9,8)n=9 Participants | 1455.0 | -936.2 - 2261.1 |
| Week 28 (n=6,9,7,8)n=9 Participants | 8929.3 | -4466.9 - 17849.8 |
| Week 30 (n=6,9,7,8)n=9 Participants | 7017.4 | -3510.7 - 14026.7 |
| Week 40 (n=5,9,8,8)n=9 Participants | 2706.5 | -1358.1 - 5393.9 |
| Week 50 (n=6,8,7,8)n=9 Participants | 1255.8 | -656.3 - 2402.9 |
| Week 54 (n=5,8,7,7)n=9 Participants | 9636.4 | -4558.5 - 20370.7 |
| Week 56 (n=4,8,7,7)n=9 Participants | 7582.4 | -3143.9 - 18286.8 |
| Week 66 (n=4,8,7,7)n=9 Participants | 3942.5 | -1539.4 - 10096.9 |
| Week 78 (n=4,8,6,7)n=9 Participants | 2465.3 | -961.9 - 6318.5 |
| Week 91 (n=0,1,1,0)n=9 Participants | 546.0 | -NA - NA |
| Week 104 (n=0,1,1,0)n=9 Participants | 414.0 | -NA - NA |
| ACC-001 30 Micrograms + QS-21Pre-study (n=6,9,9,8)n=9 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=6,9,9,8)n=9 Participants | 67.0 | -34.1 - 131.8 |
| Week 4 (n=6,9,9,8)n=9 Participants | 79.0 | -27.5 - 227.1 |
| Week 6 (n=6,9,9,8)n=9 Participants | 5702.6 | -1181.1 - 17288.0 |
| Week 8 (n=6,9,9,8)n=9 Participants | 3423.9 | -1182.1 - 9917.0 |
| Week 10 (n=6,9,9,8)n=9 Participants | 2012.4 | -643.4 - 6294.9 |
| Week 14 (n=6,9,9,8)n=9 Participants | 9983.5 | -2820.9 - 35333.3 |
| Week 16 (n=6,9,9,8)n=9 Participants | 9228.0 | -2930.5 - 29058.2 |
| Week 24 (n=6,9,9,8)n=9 Participants | 3903.1 | -1151.8 - 13226.8 |
| Week 28 (n=6,9,7,8)n=9 Participants | 7429.5 | -3925.7 - 14060.5 |
| Week 30 (n=6,9,7,8)n=9 Participants | 6162.2 | -3062.2 - 12400.6 |
| Week 40 (n=5,9,8,8)n=9 Participants | 3615.5 | -1145.5 - 11411.2 |
| Week 50 (n=6,8,7,8)n=9 Participants | 1261.4 | -699.2 - 2275.9 |
| Week 54 (n=5,8,7,7)n=9 Participants | 8604.6 | -4030.7 - 18368.8 |
| Week 56 (n=4,8,7,7)n=9 Participants | 6201.5 | -2921.4 - 13164.5 |
| Week 66 (n=4,8,7,7)n=9 Participants | 2452.5 | -1442.5 - 4169.7 |
| Week 78 (n=4,8,6,7)n=9 Participants | 1316.3 | -645.0 - 2686.1 |
| Week 91 (n=0,1,1,0)n=9 Participants | 389.0 | -NA - NA |
| Week 104 (n=0,1,1,0)n=9 Participants | 285.0 | -NA - NA |
| QS-21Pre-study (n=6,9,9,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 2 (n=6,9,9,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 4 (n=6,9,9,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 6 (n=6,9,9,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 8 (n=6,9,9,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 10 (n=6,9,9,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 14 (n=6,9,9,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 16 (n=6,9,9,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 24 (n=6,9,9,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 28 (n=6,9,7,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 30 (n=6,9,7,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 40 (n=5,9,8,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 50 (n=6,8,7,8)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 54 (n=5,8,7,7)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 56 (n=4,8,7,7)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 66 (n=4,8,7,7)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 78 (n=4,8,6,7)n=8 Participants | 50.0 | -50.0 - 50.0 |
| Week 91 (n=0,1,1,0)n=8 Participants | NA | -NA - NA |
| Week 104 (n=0,1,1,0)n=8 Participants | NA | -NA - NA |
Secondary/registry result/low confidence
Anti-a-beta IgM Titer at Specified Visits
Time frame:Baseline up to 24 months
descriptive
Posted result
| Group | Value (geometric_mean), Units/mL | Reported bounds |
|---|---|---|
| ACC-001 3 Micrograms + QS-21Pre-study (n=6,9,9,8)n=6 Participants | 30.9 | -17.9 - 53.6 |
| Week 2 (n=6,9,9,8)n=6 Participants | 77.1 | -17.1 - 347.0 |
| Week 4 (n=6,9,9,8)n=6 Participants | 108.5 | -19.4 - 605.6 |
| Week 6 (n=6,9,9,8)n=6 Participants | 953.2 | -95.7 - 9493.1 |
| Week 8 (n=6,9,9,8)n=6 Participants | 848.6 | -85.6 - 8414.6 |
| Week 10 (n=6,9,9,8)n=6 Participants | 850.8 | -147.5 - 4907.8 |
| Week 14 (n=6,9,9,8)n=6 Participants | 1487.6 | -288.1 - 7682.0 |
| Week 16 (n=6,9,9,8)n=6 Participants | 1503.2 | -254.5 - 8880.8 |
| Week 24 (n=6,9,9,8)n=6 Participants | 898.5 | -222.1 - 3634.1 |
| Week 28 (n=6,9,7,8)n=6 Participants | 885.9 | -240.0 - 3270.2 |
| Week 30 (n=6,9,7,8)n=6 Participants | 859.5 | -273.2 - 2704.0 |
| Week 40 (n=5,9,8,8)n=6 Participants | 449.0 | -110.4 - 1825.7 |
| Week 50 (n=6,8,7,8)n=6 Participants | 354.2 | -75.6 - 1659.4 |
| Week 54 (n=5,8,7,7)n=6 Participants | 680.7 | -120.0 - 3861.3 |
| Week 56 (n=4,8,7,7)n=6 Participants | 1768.3 | -342.4 - 9132.4 |
| Week 66 (n=4,8,7,7)n=6 Participants | 1213.0 | -244.1 - 6027.2 |
| Week 78 (n=4,8,6,7)n=6 Participants | 952.8 | -251.0 - 3617.1 |
| Week 91 (n=0,1,1,0)n=6 Participants | NA | -NA - NA |
| Week 104 (n=0,1,1,0)n=6 Participants | NA | -NA - NA |
| ACC-001 10 Micrograms + QS-21Pre-study (n=6,9,9,8)n=9 Participants | 28.2 | -21.3 - 37.4 |
| Week 2 (n=6,9,9,8)n=9 Participants | 92.0 | -31.7 - 266.6 |
| Week 4 (n=6,9,9,8)n=9 Participants | 141.5 | -41.6 - 481.5 |
| Week 6 (n=6,9,9,8)n=9 Participants | 2988.4 | -879.2 - 10157.9 |
| Week 8 (n=6,9,9,8)n=9 Participants | 2940.1 | -812.5 - 10639.6 |
| Week 10 (n=6,9,9,8)n=9 Participants | 2432.1 | -661.4 - 8943.5 |
| Week 14 (n=6,9,9,8)n=9 Participants | 2231.0 | -728.6 - 6831.2 |
| Week 16 (n=6,9,9,8)n=9 Participants | 2484.8 | -797.6 - 7740.9 |
| Week 24 (n=6,9,9,8)n=9 Participants | 1421.8 | -442.7 - 4565.8 |
| Week 28 (n=6,9,7,8)n=9 Participants | 3395.8 | -1356.5 - 8500.9 |
| Week 30 (n=6,9,7,8)n=9 Participants | 3729.9 | -1286.6 - 10812.9 |
| Week 40 (n=5,9,8,8)n=9 Participants | 2480.5 | -760.2 - 8093.8 |
| Week 50 (n=6,8,7,8)n=9 Participants | 1330.0 | -388.5 - 4553.3 |
| Week 54 (n=5,8,7,7)n=9 Participants | 2605.4 | -862.1 - 7874.2 |
| Week 56 (n=4,8,7,7)n=9 Participants | 2570.6 | -794.2 - 8320.4 |
| Week 66 (n=4,8,7,7)n=9 Participants | 1872.7 | -523.3 - 6701.7 |
| Week 78 (n=4,8,6,7)n=9 Participants | 1650.3 | -491.4 - 5542.5 |
| Week 91 (n=0,1,1,0)n=9 Participants | 219.0 | -NA - NA |
| Week 104 (n=0,1,1,0)n=9 Participants | 154.0 | -NA - NA |
| ACC-001 30 Micrograms + QS-21Pre-study (n=6,9,9,8)n=9 Participants | 25.0 | -25.0 - 25.0 |
| Week 2 (n=6,9,9,8)n=9 Participants | 53.5 | -22.5 - 127.6 |
| Week 4 (n=6,9,9,8)n=9 Participants | 108.5 | -41.0 - 286.9 |
| Week 6 (n=6,9,9,8)n=9 Participants | 2381.4 | -662.7 - 8556.9 |
| Week 8 (n=6,9,9,8)n=9 Participants | 2776.2 | -622.2 - 12386.2 |
| Week 10 (n=6,9,9,8)n=9 Participants | 2323.9 | -482.5 - 11192.7 |
| Week 14 (n=6,9,9,8)n=9 Participants | 4438.5 | -1000.5 - 19689.6 |
| Week 16 (n=6,9,9,8)n=9 Participants | 4590.6 | -1041.7 - 20230.3 |
| Week 24 (n=6,9,9,8)n=9 Participants | 2396.4 | -643.2 - 8928.8 |
| Week 28 (n=6,9,7,8)n=9 Participants | 3592.8 | -628.7 - 20531.3 |
| Week 30 (n=6,9,7,8)n=9 Participants | 2956.7 | -636.6 - 13732.9 |
| Week 40 (n=5,9,8,8)n=9 Participants | 1967.3 | -421.5 - 9183.1 |
| Week 50 (n=6,8,7,8)n=9 Participants | 1326.8 | -233.3 - 7546.2 |
| Week 54 (n=5,8,7,7)n=9 Participants | 3017.0 | -678.8 - 13408.9 |
| Week 56 (n=4,8,7,7)n=9 Participants | 3051.9 | -618.2 - 15066.0 |
| Week 66 (n=4,8,7,7)n=9 Participants | 1825.1 | -346.2 - 9621.6 |
| Week 78 (n=4,8,6,7)n=9 Participants | 844.9 | -155.4 - 4594.7 |
| Week 91 (n=0,1,1,0)n=9 Participants | 351.0 | -NA - NA |
| Week 104 (n=0,1,1,0)n=9 Participants | 258.0 | -NA - NA |
| QS-21Pre-study (n=6,9,9,8)n=8 Participants | 41.5 | -21.8 - 78.8 |
| Week 2 (n=6,9,9,8)n=8 Participants | 42.4 | -21.6 - 83.3 |
| Week 4 (n=6,9,9,8)n=8 Participants | 43.7 | -21.6 - 88.3 |
| Week 6 (n=6,9,9,8)n=8 Participants | 43.0 | -21.6 - 85.9 |
| Week 8 (n=6,9,9,8)n=8 Participants | 46.9 | -23.7 - 92.9 |
| Week 10 (n=6,9,9,8)n=8 Participants | 36.1 | -19.1 - 68.2 |
| Week 14 (n=6,9,9,8)n=8 Participants | 37.6 | -19.6 - 72.3 |
| Week 16 (n=6,9,9,8)n=8 Participants | 40.5 | -18.4 - 89.5 |
| Week 24 (n=6,9,9,8)n=8 Participants | 40.1 | -18.4 - 87.1 |
| Week 28 (n=6,9,7,8)n=8 Participants | 42.1 | -21.3 - 83.3 |
| Week 30 (n=6,9,7,8)n=8 Participants | 38.9 | -19.4 - 78.2 |
| Week 40 (n=5,9,8,8)n=8 Participants | 37.8 | -19.2 - 74.4 |
| Week 50 (n=6,8,7,8)n=8 Participants | 39.9 | -17.9 - 88.8 |
| Week 54 (n=5,8,7,7)n=8 Participants | 48.3 | -19.2 - 121.1 |
| Week 56 (n=4,8,7,7)n=8 Participants | 40.5 | -16.4 - 100.0 |
| Week 66 (n=4,8,7,7)n=8 Participants | 46.0 | -20.2 - 104.4 |
| Week 78 (n=4,8,6,7)n=8 Participants | 48.3 | -19.0 - 122.8 |
| Week 91 (n=0,1,1,0)n=8 Participants | NA | -NA - NA |
| Week 104 (n=0,1,1,0)n=8 Participants | NA | -NA - NA |
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
- PMID25731629via 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.