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CompletedPhase 2Results posted

Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

A Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer's Disease

Lead sponsor

Pfizer

Asset

ACC-001

Listed sites

24

Recruiting sites

-

Enrollment

86

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-26•MRI contraindications excluded

Primary endpoint

•Treatment-emergent AEs or Serious Adverse Events (SAEs)

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

Eudract number2006-002061-39
Org study ID3134K1-200
Secondary IDB2571004Alias Study Number
NCT IDNCT00479557

Timeline

Milestones

Study start2007-05 (month precision)
Study first posted2007-05-28estimated
Primary completion2013-01actual (month precision)
Study completion2013-01actual (month precision)
Last update posted2016-01-01estimated
Results first posted2016-01-01estimated

Assets

Drug assets

ACC-001

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 probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)
•Brain MRI consistent with Alzheimer Disease
•Concurent use of Chloniesterase inhibitor or memantine allowed if stable
•Other inclusion criteria apply

Exclusion criteria

•Significant Neurological Disease other than Alzheimer's disease
•Major psychiatric disorder
•Contraindication to undergo brain MRI
•Clinically significant systemic illness
•Other exclusion criteria apply

Endpoints (8)

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

Other (unclassified)
6
Safety / tolerability / PK
2

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)

Time frame:approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.

threshold achievement, event

Primary/registry result

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)

Time frame:approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.

threshold achievement, event

Posted result

GroupValue (number), percentage of participantsReported bounds
ACC 3 µg+QS-21Percentage of participants with AEsn=36 Participants97.2-
Percentage of participants with SAEsn=36 Participants16.7-
ACC 10 µg+QS-21Percentage of participants with AEsn=60 Participants93.3-
Percentage of participants with SAEsn=60 Participants18.3-
ACC 30 µg+QS-21Percentage of participants with AEsn=40 Participants90.0-
Percentage of participants with SAEsn=40 Participants17.5-
ACC 10 µgPercentage of participants with AEsn=35 Participants91.4-
Percentage of participants with SAEsn=35 Participants14.3-
ACC 30 µgPercentage of participants with AEsn=12 Participants83.3-
Percentage of participants with SAEsn=12 Participants41.7-
QS-21 AlonePercentage of participants with AEsn=44 Participants90.9-
Percentage of participants with SAEsn=44 Participants11.4-
Phosphate Buffered SalinePercentage of participants with AEsn=17 Participants100-
Percentage of participants with SAEsn=17 Participants17.6-

Other (unclassified)

6 endpoints
Secondary/protocol endpoint/low confidence

Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

Time frame:Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

descriptive

Secondary/protocol endpoint/low confidence

GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

Time frame:Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

descriptive

Secondary/protocol endpoint/low confidence

Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)

Time frame:Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

change from baseline, improvement

Secondary/registry result/low confidence

Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

Time frame:Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

descriptive

Posted result

GroupValue (geometric_mean), U/mLReported bounds
ACC 3 µg+QS-21Baseline (N: 36, 59, 40, 35, 12, 44, 17)n=36 Participants50.0-50.0 - 50.0
Week 2 (N: 35, 60, 39, 35, 12, 43, 16)n=36 Participants56.6-49.1 - 65.3
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=36 Participants53.2-48.5 - 58.4
Week 6 (N: 36, 58, 37, 33, 12, 41, 16)n=36 Participants634.8-322.7 - 1248.5
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=36 Participants497.4-253.5 - 976.1
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=36 Participants292.3-156.5 - 546.0
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=36 Participants907.5-474.6 - 1735.6
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=36 Participants996.1-487.1 - 2037.1
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=36 Participants547.8-278.8 - 1076.3
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=36 Participants2011.2-986.9 - 4098.8
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=36 Participants2028.9-1035.8 - 3973.8
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=36 Participants1167.3-609.1 - 2237.1
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=36 Participants937.3-482.0 - 1822.6
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=36 Participants2031.6-1024.2 - 4029.7
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=36 Participants2635.7-1355.5 - 5125.2
Week 66 (N: 31, 54,34, 31, 9, 33, 15)n=36 Participants1372.0-717.1 - 2625.1
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=36 Participants1108.4-585.1 - 2099.4
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=36 Participants1824.6-1063.2 - 3131.2
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=36 Participants1326.1-785.0 - 2240.2
ACC 10 µg+QS-21Baseline (N: 36, 59, 40, 35, 12, 44, 17)n=60 Participants50.0-50.0 - 50.0
Week 2 (N: 35, 60, 39, 35, 12, 43, 16)n=60 Participants69.0-57.4 - 83.0
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=60 Participants77.1-61.9 - 96.0
Week 6 (N: 36, 58, 37, 33, 12, 41, 16)n=60 Participants1089.4-646.0 - 1837.2
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=60 Participants885.2-530.0 - 1478.7
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=60 Participants762.8-468.5 - 1242.2
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=60 Participants2892.3-1705.9 - 4903.8
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=60 Participants3273.2-2083.9 - 5141.4
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=60 Participants1827.6-1145.3 - 2916.1
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=60 Participants4299.6-2843.8 - 6500.8
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=60 Participants4316.8-2900.2 - 6425.2
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=60 Participants2147.2-1407.6 - 3275.3
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=60 Participants1364.4-911.9 - 2041.4
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=60 Participants5744.6-3609.1 - 9143.7
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=60 Participants5906.1-4058.8 - 8594.2
Week 66 (N: 31, 54,34, 31, 9, 33, 15)n=60 Participants2867.4-1835.9 - 4478.5
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=60 Participants1867.5-1197.4 - 2912.5
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=60 Participants2497.0-644.8 - 9670.1
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=60 Participants2212.7-406.4 - 12048.4
ACC 30 µg+QS-21Baseline (N: 36, 59, 40, 35, 12, 44, 17)n=40 Participants50.0-50.0 - 50.0
Week 2 (N: 35, 60, 39, 35, 12, 43, 16)n=40 Participants86.5-65.7 - 113.9
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=40 Participants82.8-63.0 - 108.8
Week 6 (N: 36, 58, 37, 33, 12, 41, 16)n=40 Participants1343.5-716.0 - 2521.1
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=40 Participants1098.2-626.9 - 1924.0
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=40 Participants878.5-531.3 - 1452.6
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=40 Participants3136.8-1877.6 - 5240.7
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=40 Participants3324.7-1959.4 - 5641.3
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=40 Participants1231.3-712.2 - 2128.6
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=40 Participants5407.7-3676.0 - 7955.3
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=40 Participants4713.0-3076.0 - 7221.2
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=40 Participants2292.9-1436.6 - 3659.8
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=40 Participants1262.3-828.5 - 1923.2
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=40 Participants6677.3-3678.7 - 12120.1
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=40 Participants7642.5-5057.9 - 11547.9
Week 66 (N: 31, 54,34, 31, 9, 33, 15)n=40 Participants2882.2-1793.1 - 4632.8
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=40 Participants1338.1-827.3 - 2164.4
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=40 Participants543.0-33.6 - 8767.8
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=40 Participants243.3-28.8 - 2052.4
ACC 10 µgBaseline (N: 36, 59, 40, 35, 12, 44, 17)n=35 Participants50.0-50.0 - 50.0
Week 2 (N: 35, 60, 39, 35, 12, 43, 16)n=35 Participants51.7-48.3 - 55.2
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=35 Participants50.0-50.0 - 50.0
Week 6 (N: 36, 58, 37, 33, 12, 41, 16)n=35 Participants73.4-50.6 - 106.4
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=35 Participants66.3-48.2 - 91.1
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=35 Participants77.0-48.0 - 123.3
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=35 Participants89.6-50.8 - 158.3
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=35 Participants91.7-55.2 - 152.1
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=35 Participants76.1-52.1 - 111.1
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=35 Participants108.9-61.9 - 191.8
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=35 Participants110.4-64.1 - 190.0
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=35 Participants97.2-62.4 - 151.3
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=35 Participants80.7-54.8 - 118.9
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=35 Participants160.6-69.7 - 370.2
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=35 Participants159.2-74.2 - 341.8
Week 66 (N: 31, 54,34, 31, 9, 33, 15)n=35 Participants166.3-78.8 - 350.9
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=35 Participants142.7-71.5 - 285.1
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=35 Participants76.8-27.8 - 211.9
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=35 Participants98.9-30.7 - 318.3
ACC 30 µgBaseline (N: 36, 59, 40, 35, 12, 44, 17)n=12 Participants50.0-50.0 - 50.0
Week 2 (N: 35, 60, 39, 35, 12, 43, 16)n=12 Participants50.0-50.0 - 50.0
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=12 Participants50.0-50.0 - 50.0
Week 6 (N: 36, 58, 37, 33, 12, 41, 16)n=12 Participants103.7-38.2 - 281.4
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=12 Participants99.8-38.8 - 256.6
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=12 Participants94.9-39.8 - 226.5
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=12 Participants199.4-73.7 - 539.8
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=12 Participants133.9-56.1 - 319.9
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=12 Participants139.1-52.1 - 371.3
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=12 Participants334.1-77.1 - 1448.3
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=12 Participants234.5-65.3 - 842.5
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=12 Participants211.0-53.6 - 830.7
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=12 Participants168.4-52.4 - 541.3
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=12 Participants491.6-85.9 - 2812.2
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=12 Participants463.7-81.1 - 2650.5
Week 66 (N: 31, 54,34, 31, 9, 33, 15)n=12 Participants280.0-56.3 - 1393.9
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=12 Participants256.1-58.2 - 1128.2
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=12 Participants50.0-50.0 - 50.0
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=12 Participants50.0-50.0 - 50.0
QS-21 AloneBaseline (N: 36, 59, 40, 35, 12, 44, 17)n=44 Participants53.1-47.1 - 59.8
Week 2 (N: 35, 60, 39, 35, 12, 43, 16)n=44 Participants52.5-47.5 - 58.1
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=44 Participants51.3-48.7 - 53.9
Week 6 (N: 36, 58, 37, 33, 12, 41, 16)n=44 Participants50.0-50.0 - 50.0
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=44 Participants52.4-47.6 - 57.7
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=44 Participants53.0-47.1 - 59.7
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=44 Participants50.0-50.0 - 50.0
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=44 Participants52.6-47.5 - 58.1
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=44 Participants52.3-47.4 - 57.4
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=44 Participants52.4-47.6 - 57.6
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=44 Participants51.8-48.2 - 55.7
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=44 Participants52.1-47.9 - 56.7
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=44 Participants52.8-47.3 - 58.8
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=44 Participants55.0-45.2 - 66.9
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=44 Participants53.4-46.7 - 60.9
Week 66 (N: 31, 54,34, 31, 9, 33, 15)n=44 Participants63.5-43.7 - 92.3
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=44 Participants53.6-46.5 - 61.6
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=44 Participants50.0-50.0 - 50.0
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=44 Participants50.0-50.0 - 50.0
Phosphate Buffered SalineBaseline (N: 36, 59, 40, 35, 12, 44, 17)n=17 Participants50.0-50.0 - 50.0
Week 2 (N: 35, 60, 39, 35, 12, 43, 16)n=17 Participants50.0-50.0 - 50.0
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=17 Participants50.0-50.0 - 50.0
Week 6 (N: 36, 58, 37, 33, 12, 41, 16)n=17 Participants50.0-50.0 - 50.0
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=17 Participants50.0-50.0 - 50.0
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=17 Participants50.0-50.0 - 50.0
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=17 Participants50.0-50.0 - 50.0
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=17 Participants50.0-50.0 - 50.0
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=17 Participants50.0-50.0 - 50.0
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=17 Participants50.0-50.0 - 50.0
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=17 Participants50.0-50.0 - 50.0
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=17 Participants50.0-50.0 - 50.0
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=17 Participants50.0-50.0 - 50.0
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=17 Participants50.0-50.0 - 50.0
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=17 Participants50.0-50.0 - 50.0
Week 66 (N: 31, 54,34, 31, 9, 33, 15)n=17 Participants50.0-50.0 - 50.0
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=17 Participants50.0-50.0 - 50.0
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=17 Participants50.0-50.0 - 50.0
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=17 Participants50.0-50.0 - 50.0
Secondary/registry result/low confidence

GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

Time frame:Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

descriptive

Posted result

GroupValue (geometric_mean), U/mLReported bounds
ACC 3 µg+QS-21Baseline (N: 36, 59, 40, 35, 12, 44, 17)n=36 Participants32.3-24.6 - 42.4
Week 2 (N: 35, 60, 39, 35, 12,43, 16)n=36 Participants85.1-54.2 - 133.8
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=36 Participants82.3-52.8 - 128.4
Week 6 (M: 36, 58, 37, 33, 12, 41, 16)n=36 Participants626.5-340.5 - 1152.8
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=36 Participants758.9-388.6 - 1482.4
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=36 Participants595.2-310.0 - 1143.0
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=36 Participants770.2-416.1 - 1425.6
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=36 Participants727.3-395.0 - 1339.0
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=36 Participants461.3-260.4 - 817.2
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=36 Participants669.0-388.0 - 1153.6
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=36 Participants717.3-432.6 - 1189.5
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=36 Participants559.0-350.7 - 891.0
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=36 Participants351.3-210.2 - 587.2
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=36 Participants477.7-305.2 - 747.7
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=36 Participants598.7-375.1 - 955.5
Week 66 (N: 31, 54, 34, 31, 9, 33, 15)n=36 Participants457.6-282.2 - 742.1
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=36 Participants368.2-238.4 - 568.7
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=36 Participants391.2-205.6 - 744.2
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=36 Participants299.1-144.2 - 620.8
ACC 10 µg+QS-21Baseline (N: 36, 59, 40, 35, 12, 44, 17)n=60 Participants38.2-30.8 - 47.2
Week 2 (N: 35, 60, 39, 35, 12,43, 16)n=60 Participants127.7-79.5 - 205.0
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=60 Participants123.4-75.9 - 200.7
Week 6 (M: 36, 58, 37, 33, 12, 41, 16)n=60 Participants1283.8-742.6 - 2219.4
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=60 Participants1903.8-1097.7 - 3301.9
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=60 Participants1697.7-980.8 - 2938.6
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=60 Participants2721.0-1608.3 - 4603.4
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=60 Participants3098.3-1904.1 - 5041.2
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=60 Participants1862.5-1137.9 - 3048.3
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=60 Participants1915.3-1256.2 - 2920.0
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=60 Participants2259.4-1524.0 - 3349.6
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=60 Participants1351.6-885.3 - 2063.3
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=60 Participants1049.6-701.4 - 1570.8
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=60 Participants1529.1-1045.4 - 2236.7
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=60 Participants1696.1-1173.6 - 2451.3
Week 66 (N: 31, 54, 34, 31, 9, 33, 15)n=60 Participants1422.0-980.7 - 2061.9
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=60 Participants1204.4-815.6 - 1778.6
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=60 Participants1203.4-399.9 - 3621.9
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=60 Participants1561.8-438.0 - 5569.0
ACC 30 µg+QS-21Baseline (N: 36, 59, 40, 35, 12, 44, 17)n=40 Participants34.2-27.7 - 42.2
Week 2 (N: 35, 60, 39, 35, 12,43, 16)n=40 Participants254.5-133.6 - 484.9
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=40 Participants276.6-143.3 - 533.6
Week 6 (M: 36, 58, 37, 33, 12, 41, 16)n=40 Participants1736.6-906.4 - 3327.1
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=40 Participants2769.5-1407.2 - 5450.9
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=40 Participants2598.1-1382.6 - 4882.0
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=40 Participants5271.3-2904.4 - 9567.3
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=40 Participants5666.4-3264.6 - 9835.3
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=40 Participants2672.4-1553.6 - 4597.0
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=40 Participants3593.2-2050.4 - 6296.9
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=40 Participants4147.2-2423.1 - 7098.1
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=40 Participants1855.9-1074.3 - 3206.1
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=40 Participants1246.4-707.2 - 2196.7
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=40 Participants2479.5-1373.5 - 4476.4
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=40 Participants2681.8-1480.7 - 4857.0
Week 66 (N: 31, 54, 34, 31, 9, 33, 15)n=40 Participants1637.2-961.9 - 2786.6
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=40 Participants1217.7-706.1 - 2100.1
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=40 Participants679.2-28.5 - 16208.4
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=40 Participants620.3-78.8 - 4882.2
ACC 10 µgBaseline (N: 36, 59, 40, 35, 12, 44, 17)n=35 Participants32.9-28.1 - 38.5
Week 2 (N: 35, 60, 39, 35, 12,43, 16)n=35 Participants46.5-32.4 - 66.7
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=35 Participants48.2-33.2 - 70.2
Week 6 (M: 36, 58, 37, 33, 12, 41, 16)n=35 Participants72.3-40.8 - 128.2
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=35 Participants70.8-40.8 - 123.0
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=35 Participants69.9-38.3 - 127.6
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=35 Participants80.8-40.2 - 162.3
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=35 Participants93.4-47.5 - 183.4
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=35 Participants90.8-48.1 - 171.3
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=35 Participants105.5-50.2 - 221.6
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=35 Participants128.4-63.1 - 261.1
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=35 Participants103.9-54.2 - 199.3
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=35 Participants84.7-45.6 - 157.3
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=35 Participants121.1-52.1 - 281.7
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=35 Participants109.8-49.4 - 244.1
Week 66 (N: 31, 54, 34, 31, 9, 33, 15)n=35 Participants114.3-51.6 - 253.1
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=35 Participants107.5-52.2 - 221.4
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=35 Participants98.9-18.4 - 530.4
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=35 Participants176.7-26.1 - 1197.0
ACC 30 µgBaseline (N: 36, 59, 40, 35, 12, 44, 17)n=12 Participants40.3-27.1 - 59.9
Week 2 (N: 35, 60, 39, 35, 12,43, 16)n=12 Participants76.9-40.5 - 146.2
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=12 Participants92.0-46.7 - 181.1
Week 6 (M: 36, 58, 37, 33, 12, 41, 16)n=12 Participants144.1-55.9 - 371.6
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=12 Participants166.4-60.3 - 459.3
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=12 Participants157.1-56.1 - 440.1
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=12 Participants290.7-71.8 - 1177.7
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=12 Participants271.8-70.5 - 1047.5
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=12 Participants296.2-56.3 - 1549.6
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=12 Participants590.9-63.4 - 5511.6
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=12 Participants343.3-49.9 - 2361.4
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=12 Participants311.9-39.1 - 2491.7
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=12 Participants294.6-41.2 - 2104.6
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=12 Participants436.9-52.1 - 3662.2
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=12 Participants438.5-51.5 - 3734.3
Week 66 (N: 31, 54, 34, 31, 9, 33, 15)n=12 Participants342.1-41.2 - 2839.9
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=12 Participants346.0-31.2 - 3832.0
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=12 Participants25.0-25.0 - 25.0
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=12 Participants25.0-25.0 - 25.0
QS-21 AloneBaseline (N: 36, 59, 40, 35, 12, 44, 17)n=44 Participants30.8-26.4 - 36.0
Week 2 (N: 35, 60, 39, 35, 12,43, 16)n=44 Participants31.5-26.6 - 37.3
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=44 Participants33.2-28.0 - 39.3
Week 6 (M: 36, 58, 37, 33, 12, 41, 16)n=44 Participants31.1-26.6 - 36.3
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=44 Participants31.0-26.1 - 36.8
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=44 Participants36.6-28.0 - 47.9
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=44 Participants31.0-25.5 - 37.8
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=44 Participants34.5-27.6 - 43.0
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=44 Participants30.9-26.1 - 36.7
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=44 Participants31.3-26.1 - 37.5
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=44 Participants37.8-27.7 - 51.6
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=44 Participants34.2-28.1 - 41.6
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=44 Participants32.2-27.1 - 38.3
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=44 Participants36.2-28.4 - 46.3
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=44 Participants34.3-27.2 - 43.2
Week 66 (N: 31, 54, 34, 31, 9, 33, 15)n=44 Participants36.1-26.5 - 49.1
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=44 Participants34.6-27.9 - 43.0
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=44 Participants28.3-20.5 - 39.1
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=44 Participants25.0-25.0 - 25.0
Phosphate Buffered SalineBaseline (N: 36, 59, 40, 35, 12, 44, 17)n=17 Participants25.0-25.0 - 25.0
Week 2 (N: 35, 60, 39, 35, 12,43, 16)n=17 Participants26.5-23.4 - 29.9
Week 4 (N: 35, 57, 38, 31, 12, 43, 16)n=17 Participants27.3-24.0 - 30.9
Week 6 (M: 36, 58, 37, 33, 12, 41, 16)n=17 Participants25.0-25.0 - 25.0
Week 8 (N: 33, 57, 39, 33, 12, 41, 17)n=17 Participants26.3-23.6 - 29.4
Week 10 (N: 34, 59, 40, 33, 12, 43, 17)n=17 Participants27.3-24.0 - 31.1
Week 14 (N: 33, 52, 39, 31, 11, 33, 14)n=17 Participants25.0-25.0 - 25.0
Week 16 (N: 33, 59, 38, 34, 12, 41, 16)n=17 Participants25.0-25.0 - 25.0
Week 24 (N: 34, 58, 37, 33, 10, 40, 16)n=17 Participants26.6-23.3 - 30.2
Week 28 (N: 31, 51, 33, 29, 8, 36, 16)n=17 Participants25.0-25.0 - 25.0
Week 30 (N: 33, 56, 36, 32, 10, 38, 16)n=17 Participants25.0-25.0 - 25.0
Week 40 (N: 32, 54, 33, 33, 9, 37, 15)n=17 Participants25.0-25.0 - 25.0
Week 50 (N: 29, 53, 33, 33, 9, 36, 16)n=17 Participants25.0-25.0 - 25.0
Week 54 (N: 27, 51, 30, 29, 9, 29, 14)n=17 Participants27.2-22.7 - 32.5
Week 56 (N: 31, 52, 34, 32, 9, 34, 15)n=17 Participants29.5-22.6 - 38.6
Week 66 (N: 31, 54, 34, 31, 9, 33, 15)n=17 Participants27.8-23.8 - 32.6
Week 78 (N: 31, 52, 32, 32, 8, 32, 14)n=17 Participants28.9-23.4 - 35.8
Week 91 (N: 15, 9, 3, 8, 2, 6, 2)n=17 Participants25.0-25.0 - 25.0
Week 104 (N: 15, 9, 4, 7, 1, 6, 2)n=17 Participants25.0-25.0 - 25.0
Secondary/registry result/low confidence

Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)

Time frame:Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

change from baseline, improvement

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

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.