Skip to main content
Delfa

← Trials/Trial dossier/NCT00955409

CompletedPhase 2Results posted

Long Term Extension 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, LONG -TERM EXTENSION STUDY TO DETERMINE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF ACC-001 WITH QS-21 ADJUVANT IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE

Lead sponsor

Pfizer

Asset

ACC-001

Listed sites

17

Recruiting sites

-

Enrollment

160

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≥10•Brain MRI excludes vasogenic edema

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 number2009-010922-21
Org study ID3134K1-2203
Secondary IDB2571007Alias Study Number
NCT IDNCT00955409

Timeline

Milestones

Study first posted2009-08-10estimated
Study start2009-11-05actual
Primary completion2013-12-17actual
Study completion2013-12-17actual
Last update posted2021-03-25actual
Results first posted2021-03-25actual

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

•Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria
•Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score ≥10

Exclusion criteria

•Significant Neurological Disease other than Alzheimer's disease
•Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
•Clinically significant systemic illness

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:24 months

threshold achievement, event

Primary/registry result

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

Time frame:24 months

threshold achievement, event

Posted result

GroupValue (number), percentage of participantsReported bounds
ACC 3 µg+QS-21 / ACC 3 µg+QS-21Percentage of participants with AEsn=21 Participants100.0-
Percentage of participants with SAEsn=21 Participants28.6-
QS-21 / ACC 3 µg+QS-21Percentage of participants with AEsn=6 Participants100.0-
Percentage of participants with SAEsn=6 Participants0-
Active / ACC 10 µg+QS-21Percentage of participants with AEsn=65 Participants93.8-
Percentage of participants with SAEsn=65 Participants24.6-
Control / ACC 10 µg+QS-21Percentage of participants with AEsn=14 Participants92.9-
Percentage of participants with SAEsn=14 Participants14.3-
Active / ACC 30 µg+QS-21Percentage of participants with AEsn=33 Participants78.8-
Percentage of participants with SAEsn=33 Participants12.1-
Control / ACC 30 μg+QS-21Percentage of participants with AEsn=20 Participants90.0-
Percentage of participants with SAEsn=20 Participants20.0-

Other (unclassified)

6 endpoints
Other/protocol endpoint/low confidence

GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

Time frame:Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

descriptive

Other/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 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)

Time frame:Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

change from baseline, improvement

Other/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 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

Time frame:Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

descriptive

Other_pre_specified/registry result/low confidence

GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

Time frame:Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

descriptive

Other_pre_specified/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 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)

Time frame:Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

change from baseline, improvement

Other_pre_specified/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 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

Time frame:Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

descriptive

Posted result

GroupValue (geometric_mean), U/mlReported bounds
ACC 3 µg+QS-21 / ACC 3 µg+QS-21Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)n=21 Participants50.0-NA - NA
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)n=21 Participants836.5-362.2 - 1932.3
Week 4 (N:21,6,41,24,5,9,27,5,16,4)n=21 Participants4523.7-2070.2 - 9885.0
Week 12 (N:21,6,41,23,4,9,27,5,16,4)n=21 Participants2540.3-1060.5 - 6084.8
Week 24 (N:21,6,39,24,4,9,27,5,15,3)n=21 Participants1466.6-607.2 - 3542.4
Week 30 (N:18,6,38,20,4,6,24,5,14,3)n=21 Participants3780.6-1941.7 - 7360.9
Week 36 (N:18,6,36,20,4,9,25,5,14,3)n=21 Participants2927.8-1368.7 - 6262.8
Week 50 (N:17,6,37,20,4,8,20,5,13,3)n=21 Participants1843.8-776.1 - 4380.0
Week 56 (N:17,6,32,19,4,8,12,4,5,3)n=21 Participants4958.8-2257.8 - 10891.0
Week 66 (N:17,6,30,19,4,7,8,5,3,3)n=21 Participants2765.0-1190.8 - 6420.3
Week 76 (N:14,5,23,19,4,7,5,5,3,3)n=21 Participants2802.1-1334.8 - 5882.6
Week 82 (N:13,5,16,18,3,7,4,4,2,3)n=21 Participants6831.1-3436.2 - 13579.9
Week 104 (N:12,5,14,17,2,5,5,2,2,3)n=21 Participants2951.6-1259.3 - 6918.3
QS-21 / ACC 3 µg+QS-21Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)n=6 Participants50.0-NA - NA
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)n=6 Participants50.0-NA - NA
Week 4 (N:21,6,41,24,5,9,27,5,16,4)n=6 Participants50.0-NA - NA
Week 12 (N:21,6,41,23,4,9,27,5,16,4)n=6 Participants50.0-NA - NA
Week 24 (N:21,6,39,24,4,9,27,5,15,3)n=6 Participants50.0-NA - NA
Week 30 (N:18,6,38,20,4,6,24,5,14,3)n=6 Participants477.1-85.4 - 2664.5
Week 36 (N:18,6,36,20,4,9,25,5,14,3)n=6 Participants267.1-53.6 - 1331.2
Week 50 (N:17,6,37,20,4,8,20,5,13,3)n=6 Participants141.3-24.5 - 813.2
Week 56 (N:17,6,32,19,4,8,12,4,5,3)n=6 Participants1441.4-159.3 - 13045.1
Week 66 (N:17,6,30,19,4,7,8,5,3,3)n=6 Participants701.5-86.0 - 5719.3
Week 76 (N:14,5,23,19,4,7,5,5,3,3)n=6 Participants842.5-107.7 - 6592.3
Week 82 (N:13,5,16,18,3,7,4,4,2,3)n=6 Participants5104.3-540.8 - 48180.8
Week 104 (N:12,5,14,17,2,5,5,2,2,3)n=6 Participants1061.0-77.8 - 14476.0
ACC 10 µg+QS-21 / ACC 10 µg+QS-21Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)n=41 Participants50.0-NA - NA
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)n=41 Participants1623.4-1015.3 - 2595.7
Week 4 (N:21,6,41,24,5,9,27,5,16,4)n=41 Participants6219.3-3853.2 - 10038.2
Week 12 (N:21,6,41,23,4,9,27,5,16,4)n=41 Participants4251.0-2709.7 - 6669.2
Week 24 (N:21,6,39,24,4,9,27,5,15,3)n=41 Participants3058.1-1887.1 - 4955.9
Week 30 (N:18,6,38,20,4,6,24,5,14,3)n=41 Participants8682.0-5670.1 - 13293.8
Week 36 (N:18,6,36,20,4,9,25,5,14,3)n=41 Participants5946.6-3807.1 - 9288.6
Week 50 (N:17,6,37,20,4,8,20,5,13,3)n=41 Participants3146.6-1945.8 - 5088.4
Week 56 (N:17,6,32,19,4,8,12,4,5,3)n=41 Participants10412.4-6365.4 - 17032.7
Week 66 (N:17,6,30,19,4,7,8,5,3,3)n=41 Participants6627.7-3946.1 - 11131.5
Week 76 (N:14,5,23,19,4,7,5,5,3,3)n=41 Participants3373.8-1763.5 - 6454.6
Week 82 (N:13,5,16,18,3,7,4,4,2,3)n=41 Participants12261.1-6635.8 - 22655.2
Week 104 (N:12,5,14,17,2,5,5,2,2,3)n=41 Participants6644.4-2583.6 - 17088.1
ACC 10 µg / ACC 10 µg+QS-21Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)n=24 Participants50.0-NA - NA
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)n=24 Participants180.2-76.4 - 425.3
Week 4 (N:21,6,41,24,5,9,27,5,16,4)n=24 Participants517.9-166.8 - 1607.6
Week 12 (N:21,6,41,23,4,9,27,5,16,4)n=24 Participants425.4-137.0 - 1320.6
Week 24 (N:21,6,39,24,4,9,27,5,15,3)n=24 Participants280.3-100.2 - 784.4
Week 30 (N:18,6,38,20,4,6,24,5,14,3)n=24 Participants1574.5-568.2 - 4363.1
Week 36 (N:18,6,36,20,4,9,25,5,14,3)n=24 Participants1029.4-346.4 - 3059.1
Week 50 (N:17,6,37,20,4,8,20,5,13,3)n=24 Participants512.4-176.5 - 1487.4
Week 56 (N:17,6,32,19,4,8,12,4,5,3)n=24 Participants4562.2-2233.3 - 9319.8
Week 66 (N:17,6,30,19,4,7,8,5,3,3)n=24 Participants2049.2-852.2 - 4927.5
Week 76 (N:14,5,23,19,4,7,5,5,3,3)n=24 Participants1479.9-575.1 - 3808.2
Week 82 (N:13,5,16,18,3,7,4,4,2,3)n=24 Participants5771.4-3264.4 - 10203.5
Week 104 (N:12,5,14,17,2,5,5,2,2,3)n=24 Participants1565.2-587.2 - 4172.5
QS-21 / ACC 10 µg+QS-21Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)n=5 Participants50.0-NA - NA
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)n=5 Participants50.0-NA - NA
Week 4 (N:21,6,41,24,5,9,27,5,16,4)n=5 Participants50.0-NA - NA
Week 12 (N:21,6,41,23,4,9,27,5,16,4)n=5 Participants50.0-NA - NA
Week 24 (N:21,6,39,24,4,9,27,5,15,3)n=5 Participants50.0-NA - NA
Week 30 (N:18,6,38,20,4,6,24,5,14,3)n=5 Participants552.2-37.8 - 8075.8
Week 36 (N:18,6,36,20,4,9,25,5,14,3)n=5 Participants282.9-43.5 - 1838.7
Week 50 (N:17,6,37,20,4,8,20,5,13,3)n=5 Participants169.6-35.8 - 804.5
Week 56 (N:17,6,32,19,4,8,12,4,5,3)n=5 Participants1720.0-108.1 - 27356.9
Week 66 (N:17,6,30,19,4,7,8,5,3,3)n=5 Participants891.0-32.6 - 24385.5
Week 76 (N:14,5,23,19,4,7,5,5,3,3)n=5 Participants628.5-26.6 - 1478.7
Week 82 (N:13,5,16,18,3,7,4,4,2,3)n=5 Participants2768.5-79.0 - 97040.9
Week 104 (N:12,5,14,17,2,5,5,2,2,3)n=5 Participants1128.4-0.1 - 25253974.1
PBS / ACC 10 μg+QS-21Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)n=9 Participants50.0-NA - NA
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)n=9 Participants50.0-NA - NA
Week 4 (N:21,6,41,24,5,9,27,5,16,4)n=9 Participants60.6-38.9 - 94.4
Week 12 (N:21,6,41,23,4,9,27,5,16,4)n=9 Participants62.0-37.8 - 101.7
Week 24 (N:21,6,39,24,4,9,27,5,15,3)n=9 Participants57.5-41.7 - 79.2
Week 30 (N:18,6,38,20,4,6,24,5,14,3)n=9 Participants317.0-27.5 - 3654.9
Week 36 (N:18,6,36,20,4,9,25,5,14,3)n=9 Participants428.0-83.8 - 2186.8
Week 50 (N:17,6,37,20,4,8,20,5,13,3)n=9 Participants333.6-63.0 - 1767.0
Week 56 (N:17,6,32,19,4,8,12,4,5,3)n=9 Participants3451.0-478.9 - 24871.3
Week 66 (N:17,6,30,19,4,7,8,5,3,3)n=9 Participants1989.2-152.1 - 26014.2
Week 76 (N:14,5,23,19,4,7,5,5,3,3)n=9 Participants1235.3-116.5 - 13096.6
Week 82 (N:13,5,16,18,3,7,4,4,2,3)n=9 Participants4779.6-706.4 - 32339.3
Week 104 (N:12,5,14,17,2,5,5,2,2,3)n=9 Participants832.4-56.5 - 12268.2
ACC 30 µg+QS-21 / ACC 30 µg+QS-21Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)n=27 Participants50.0-NA - NA
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)n=27 Participants1718.3-1101.2 - 2681.3
Week 4 (N:21,6,41,24,5,9,27,5,16,4)n=27 Participants8436.2-5569.8 - 12778.0
Week 12 (N:21,6,41,23,4,9,27,5,16,4)n=27 Participants3604.3-2009.6 - 6464.5
Week 24 (N:21,6,39,24,4,9,27,5,15,3)n=27 Participants2146.4-1309.0 - 3519.7
Week 30 (N:18,6,38,20,4,6,24,5,14,3)n=27 Participants12939.5-8634.4 - 19391.2
Week 36 (N:18,6,36,20,4,9,25,5,14,3)n=27 Participants6228.9-3794.3 - 10225.7
Week 50 (N:17,6,37,20,4,8,20,5,13,3)n=27 Participants2439.0-1369.5 - 4343.8
Week 56 (N:17,6,32,19,4,8,12,4,5,3)n=27 Participants5241.2-2459.3 - 11170.1
Week 66 (N:17,6,30,19,4,7,8,5,3,3)n=27 Participants4341.1-1677.8 - 11232.1
Week 76 (N:14,5,23,19,4,7,5,5,3,3)n=27 Participants2030.7-576.9 - 7147.4
Week 82 (N:13,5,16,18,3,7,4,4,2,3)n=27 Participants1902.0-35.0 - 103340.7
Week 104 (N:12,5,14,17,2,5,5,2,2,3)n=27 Participants1447.6-548.5 - 3820.9
ACC 30 µg / ACC 30 µg+QS-21Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)n=6 Participants50.0-NA - NA
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)n=6 Participants424.2-70.9 - 2539.4
Week 4 (N:21,6,41,24,5,9,27,5,16,4)n=6 Participants4223.0-185.0 - 96408.3
Week 12 (N:21,6,41,23,4,9,27,5,16,4)n=6 Participants761.6-33.2 - 17472.9
Week 24 (N:21,6,39,24,4,9,27,5,15,3)n=6 Participants541.1-31.3 - 9362.1
Week 30 (N:18,6,38,20,4,6,24,5,14,3)n=6 Participants1374.9-54.4 - 34722.9
Week 36 (N:18,6,36,20,4,9,25,5,14,3)n=6 Participants706.7-33.6 - 14852.3
Week 50 (N:17,6,37,20,4,8,20,5,13,3)n=6 Participants527.7-33.4 - 8348.8
Week 56 (N:17,6,32,19,4,8,12,4,5,3)n=6 Participants2216.1-38.0 - 129086.9
Week 66 (N:17,6,30,19,4,7,8,5,3,3)n=6 Participants1315.8-117.1 - 14780.6
Week 76 (N:14,5,23,19,4,7,5,5,3,3)n=6 Participants875.0-94.7 - 8083.3
Week 82 (N:13,5,16,18,3,7,4,4,2,3)n=6 Participants3736.1-594.2 - 23491.3
Week 104 (N:12,5,14,17,2,5,5,2,2,3)n=6 Participants3654.5-11.3 - 1181935.3
QS-21 / ACC 30 µg+QS-21Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)n=16 Participants58.8-41.6 - 83.3
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)n=16 Participants59.5-41.0 - 86.3
Week 4 (N:21,6,41,24,5,9,27,5,16,4)n=16 Participants144.7-67.9 - 308.0
Week 12 (N:21,6,41,23,4,9,27,5,16,4)n=16 Participants89.3-43.7 - 182.5
Week 24 (N:21,6,39,24,4,9,27,5,15,3)n=16 Participants78.9-42.6 - 146.1
Week 30 (N:18,6,38,20,4,6,24,5,14,3)n=16 Participants1889.4-570.8 - 6254.5
Week 36 (N:18,6,36,20,4,9,25,5,14,3)n=16 Participants1018.5-297.8 - 3483.6
Week 50 (N:17,6,37,20,4,8,20,5,13,3)n=16 Participants651.3-189.9 - 2233.5
Week 56 (N:17,6,32,19,4,8,12,4,5,3)n=16 Participants578.3-26.6 - 12559.5
Week 66 (N:17,6,30,19,4,7,8,5,3,3)n=16 Participants968.4-43.0 - 21784.1
Week 76 (N:14,5,23,19,4,7,5,5,3,3)n=16 Participants494.1-1.2 - 198416.2
Week 82 (N:13,5,16,18,3,7,4,4,2,3)n=16 Participants1617.1-3.0 - 868223.9
Week 104 (N:12,5,14,17,2,5,5,2,2,3)n=16 Participants321.9-0.0 - 12636639.8
PBS / ACC 30 μg+QS-21Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)n=4 Participants50.0-NA - NA
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)n=4 Participants50.0-NA - NA
Week 4 (N:21,6,41,24,5,9,27,5,16,4)n=4 Participants100.1-11.0 - 912.6
Week 12 (N:21,6,41,23,4,9,27,5,16,4)n=4 Participants87.9-14.6 - 529.8
Week 24 (N:21,6,39,24,4,9,27,5,15,3)n=4 Participants50.0-NA - NA
Week 30 (N:18,6,38,20,4,6,24,5,14,3)n=4 Participants4360.1-30.3 - 627361.8
Week 36 (N:18,6,36,20,4,9,25,5,14,3)n=4 Participants1164.2-23.4 - 57811.5
Week 50 (N:17,6,37,20,4,8,20,5,13,3)n=4 Participants401.4-4.5 - 35461.1
Week 56 (N:17,6,32,19,4,8,12,4,5,3)n=4 Participants8033.5-584.5 - 110404.7
Week 66 (N:17,6,30,19,4,7,8,5,3,3)n=4 Participants5403.5-171.1 - 170698.5
Week 76 (N:14,5,23,19,4,7,5,5,3,3)n=4 Participants2042.8-107.4 - 38841.8
Week 82 (N:13,5,16,18,3,7,4,4,2,3)n=4 Participants9922.5-2059.8 - 47798.6
Week 104 (N:12,5,14,17,2,5,5,2,2,3)n=4 Participants1340.5-421.5 - 4263.3

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.