TerminatedPhase 3Results posted

Study Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients

A Phase Iii, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Efficacy And Safety Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Mild To Moderate Alzheimer Disease Who Are Apolipoprotein E 4 Carriers

Lead sponsor

Pfizer

Asset

Bapineuzumab

Listed sites

288

Recruiting sites

Enrollment

1,100

actual

Study population

Alzheimer’s disease

Key I/E criteria

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

Primary endpoints

•ADAS-Cog•Disability Assessment for Dementia (DAD) Total Score

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 number2007-005995-14

Org study ID3133K1-3001

Secondary IDB2521002Alias Study Number

NCT IDNCT00676143

Timeline

Milestones

Study start2008-01 (month precision)

Study first posted2008-05-12estimated

Primary completion2012-10actual (month precision)

Study completion2012-11actual (month precision)

Last update posted2016-06-10estimated

Results first posted2016-06-10estimated

Assets

Drug assets

Bapineuzumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age88 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable AD, with MMSE score of 16-26, and brain MRI consistent with the diagnosis of AD

•Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.

•Caregiver will participate and be able to attend clinic visits with patient

Exclusion criteria

•Significant neurological disease other than AD, or a major psychiatric disorder

•Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal objects in the body)

•Woman of childbearing potential

Endpoints (34)

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

Function / daily living

Amyloid biomarkers

Tau biomarkers

Caregiver / quality of life

Global cognition

18 endpoints

Primary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78

Time frame:Baseline and 78 weeks

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)/11 Subscale Total Score at Week 78

Time frame:Baseline and 78 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Unit on a scale	Standard error
Placebon=300 Participants	7.31	0.47
Bapineuzumabn=414 Participants	7.32	0.39

Mean Difference (Final Values)0.0295% CI-1.18 - 1.22p0.979Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71

Time frame:Baseline and 71 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78

Time frame:Week 39 to Week 78

ADAS-Cog

threshold achievement, improvement

Secondary/protocol endpoint

Divergence of Effect on the DAD Total Scores From Week 39 to Week 78

Time frame:Week 39 to Week 78

ADAS-Cog

threshold achievement, improvement

Secondary/protocol endpoint

Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)

Time frame:Baseline and 78 Weeks

ADAS-Cog

time to event, event

Secondary/protocol endpoint

Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)

Time frame:Baseline and 78 Weeks

ADAS-Cog

time to event, event

Secondary/protocol endpoint

Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)

Time frame:Baseline and 78 Weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)

Time frame:Baseline and 78 Weeks

ADAS-Cog

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78

Time frame:Baseline and 78 Weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Brain Volume, as Assessed by Magnetic Resonance Imaging Brain Boundary Shift Integral (MRI BBSI), at Week 71

Time frame:Baseline and 71 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Milliliter (mL)/year	Standard error
Placebon=131 Participants	17.64	0.69
Bapineuzumabn=197 Participants	17.51	0.56

Mean Difference (Final Values)-0.1395% CI-1.89 - 1.63p0.884Mixed Models Analysis

Secondary/registry result

Divergence of Effect on the ADAS-Cog/11 Total Scores From Week 39 to Week 78

Time frame:Week 39 to Week 78

ADAS-Cog

threshold achievement, improvement

Posted result

Group	Value (least_squares_mean), Units/Year	Standard error
PlaceboWeek 39n=431 Participants	2.95	0.30
Week 52n=431 Participants	4.40	0.34
Week 65n=431 Participants	5.76	0.39
Week 78n=431 Participants	7.31	0.47
Bapineuzumab 0.5 mg/kgWeek 39n=650 Participants	2.68	0.25
Week 52n=650 Participants	4.08	0.29
Week 65n=650 Participants	5.16	0.32
Week 78n=650 Participants	7.32	0.39

Mean Difference (Final Values)0.2495% CI-0.97 - 1.45p0.700Mixed Models Analysis

Treatment Difference: Bapineuzumab - Placebo

Secondary/registry result

Divergence of Effect on the DAD Total Scores From Week 39 to Week 78

Time frame:Week 39 to Week 78

ADAS-Cog

threshold achievement, improvement

Posted result

Group	Value (least_squares_mean), Units/Year	Standard error
PlaceboWeek 39n=431 Participants	-6.60	0.65
Week 52n=431 Participants	-9.34	0.73
Week 65n=431 Participants	-12.14	0.91
Week 78n=431 Participants	-14.94	1.00
Bapineuzumab 0.5 mg/kgWeek 39n=650 Participants	-6.93	0.54
Week 52n=650 Participants	-9.34	0.61
Week 65n=650 Participants	-13.04	0.76
Week 78n=650 Participants	-14.89	0.84

Mean Difference (Final Values)0.0995% CI-2.61 - 2.78p0.949Mixed Models Analysis

Treatment Difference: Bapineuzumab - Placebo

Secondary/registry result

Time to First Median Placebo Deterioration on ADAS-Cog/11 Total Score (European Union [EU] Analysis Plan)

Time frame:Baseline and 78 Weeks

ADAS-Cog

time to event, event

Posted result

Group	Value (median), Days	Reported bounds
Placebon=431 Participants	463.0	-455.0 - 546.0
Bapineuzumabn=650 Participants	457.0	-455.0 - 541.0

p0.684Log Rank

Secondary/registry result

Time to First Clinically Meaningful Deterioration on ADAS-Cog/11 Total Score (United States [US] Analysis Plan)

Time frame:Baseline and 78 Weeks

ADAS-Cog

time to event, event

Posted result

Group	Value (median), Days	Reported bounds
Placebon=431 Participants	NA	-546.0 - NA
Bapineuzumabn=650 Participants	546.0	-546.0 - NA

p0.383Log Rank

Secondary/registry result

Percentage of Participants With Worsening From Baseline in ADAS-Cog/11 Total Score at Week 78 (EU Analysis Plan)

Time frame:Baseline and 78 Weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
PlaceboWorsening of 0 pointsn=431 Participants	18.3	-14.8 - 22.3
Worsening of 3 pointsn=431 Participants	30.4	-26.1 - 35.0
Worsening of 7 pointsn=431 Participants	42.5	-37.7 - 47.3
BapineuzumabWorsening of 0 pointsn=650 Participants	15.5	-12.8 - 18.6
Worsening of 3 pointsn=650 Participants	25.5	-22.2 - 29.1
Worsening of 7 pointsn=650 Participants	38.0	-34.3 - 41.9

Secondary/registry result

Percentage of Responders for ADAS-Cog/11 Total Score at Week 78 (US Analysis Plan)

Time frame:Baseline and 78 Weeks

ADAS-Cog

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participant	Reported bounds
Placebon=431 Participants	42.2	-
Bapineuzumabn=650 Participants	37.1	-

p0.086Cochran-Mantel-Haenszel

Secondary/registry result

Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SOB) Total Score at Week 78

Time frame:Baseline and 78 Weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebon=310 Participants	2.59	0.16
Bapineuzumabn=427 Participants	2.44	0.13

Mean Difference (Final Values)-0.1595% CI-0.55 - 0.24p0.448Mixed Models Analysis

Change in CDR-SOB total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.

Function / daily living

10 endpoints

Primary/protocol endpoint

Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78

Time frame:Baseline and 78 weeks

change from baseline, improvement

Primary/registry result

Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 78

Time frame:Baseline and 78 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Unit on a scale	Standard deviation
Placebon=301 Participants	-14.94	1.00
Bapineuzumabn=411 Participants	-14.89	0.84

Mean Difference (Final Values)0.0495% CI-2.51 - 2.60p0.973Mixed Models Analysis

Secondary/protocol endpoint

Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)

Time frame:Baseline and 78 Weeks

time to event, event

Secondary/protocol endpoint

Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)

Time frame:Baseline and 78 Weeks

time to event, event

Secondary/protocol endpoint

Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)

Time frame:Baseline and 78 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)

Time frame:Baseline and 78 Weeks

threshold achievement, improvement

Secondary/registry result

Time to First Median Placebo Deterioration on DAD Total Score (EU Analysis Plan)

Time frame:Baseline and 78 Weeks

time to event, event

Posted result

Group	Value (median), Days	Reported bounds
Placebon=431 Participants	464.0	-455.0 - 546.0
Bapineuzumabn=650 Participants	456.0	-449.0 - 539.0

p0.191Log Rank

Secondary/registry result

Time to First Clinically Meaningful Deterioration on DAD Total Score (US Analysis)

Time frame:Baseline and 78 Weeks

time to event, event

Posted result

Group	Value (median), Days	Reported bounds
Placebon=431 Participants	546.0	-542.0 - 546.0
Bapineuzumabn=650 Participants	546.0	-540.0 - 546.0

p0.478Log Rank

Secondary/registry result

Percentage of Participants With Worsening From Baseline in DAD Total Score at Week 78 (EU Analysis Plan)

Time frame:Baseline and 78 Weeks

change from baseline, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
PlaceboWorsening of 0 pointsn=431 Participants	17.2	-13.7 - 21.1
Worsening of 6 pointsn=431 Participants	29.9	-25.6 - 34.5
Worsening of 12 pointsn=431 Participants	39.7	-35.0 - 44.5
BapineuzumabWorsening of 0 pointsn=650 Participants	18.6	-15.7 - 21.8
Worsening of 6 pointsn=650 Participants	27.4	-24.0 - 31.0
Worsening of 12 pointsn=650 Participants	34.9	-31.3 - 38.7

Secondary/registry result

Percentage of Responders for DAD Total Score at Week 78 (US Analysis Plan)

Time frame:Baseline and 78 Weeks

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participant	Reported bounds
Placebon=431 Participants	39.7	-
Bapineuzumabn=650 Participants	34.9	-

p0.120Cochran-Mantel-Haenszel

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Brain Amyloid Burden at Week 71

Time frame:Baseline and 71 weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline in Brain Amyloid Burden at Week 71

Time frame:Baseline and 71 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), standard uptake value ratio	Standard error
Placebon=12 Participants	0.03	0.04
Bapineuzumabn=15 Participants	-0.04	0.03

Mean Difference (Final Values)-0.0795% CI-0.17 - 0.03p0.159Mixed Models Analysis

Tau biomarkers

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71

Time frame:Baseline and 71 Weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline in Cerebrospinal Fluid (CSF) Phospho-tau Levels at Week 71

Time frame:Baseline and 71 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebon=62 Participants	0.83	2.04
Bapineuzumabn=76 Participants	-0.55	1.84

Mean Difference (Final Values)-1.3895% CI-6.89 - 4.13p0.620ANCOVA

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Dependence Scale Total Score at Week 78

Time frame:Baseline and 78 Weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline in Dependence Scale Total Score at Week 78

Time frame:Baseline and 78 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Unit on a scale	Standard error
Placebon=316 Participants	1.33	0.12
Bapineuzumabn=437 Participants	1.22	0.10

Mean Difference (Final Values)-0.1195% CI-0.41 - 0.13p0.462Mixed Models Analysis

Change in DS total score was analyzed using a restricted maximum likelihood-based mixed model for repeated measures.

Publications (2)

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.