TerminatedPhase 3Results posted

Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients

A Phase 3, 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 Non-carriers

Lead sponsor

Pfizer

Asset

Bapineuzumab

Listed sites

346

Recruiting sites

Enrollment

901

actual

Study population

Alzheimer’s disease

Key I/E criteria

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

Primary endpoints

•ADAS-Cog•The Disability Assessment for Demential (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 number2007-005994-79

Org study ID3133K1-3000

Secondary IDB2521001Alias Study Number

NCT IDNCT00667810

Timeline

Milestones

Study first posted2008-04-28estimated

Study start2008-06 (month precision)

Primary completion2012-10actual (month precision)

Study completion2013-08actual (month precision)

Last update posted2016-01-08estimated

Results first posted2016-01-08estimated

Assets

Drug assets

Bapineuzumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age89 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of probable Alzheimer Disease (AD), with Mini Mental State Examination (MMSE) score of 16-26, and brain magnetic resonance imaging (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

•Major psychiatric disorder

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

•Women 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

16 endpoints

Primary/protocol endpoint

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

Time frame:78 weeks

ADAS-Cog

change from baseline, improvement

Primary/registry result

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

Time frame:78 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Bapineuzumab 0.5 mg/kgn=255 Participants	6.05	0.71
Bapineuzumab 1.0 mg/kgn=253 Participants	8.07	0.73
Placebon=328 Participants	7.88	0.64

Mean Difference (Final Values)-1.8395% CI-3.71 - 0.05p0.057Mixed Models Analysis

Mean Difference (Final Values)0.1995% CI-1.73 - 2.10p0.848Mixed Models Analysis

Secondary/protocol endpoint

The Change From Baseline in Brain Volume at Week 71

Time frame: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:39 Weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

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

Time frame: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: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 (European Union Analysis Plan)

Time frame:78 Weeks

ADAS-Cog

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame: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:78 Weeks

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

change from baseline, improvement

Secondary/registry result

The Change From Baseline in Brain Volume at Week 71

Time frame:71 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mL/year	Standard error
Bapineuzumab 0.5 mg/kgn=122 Participants	18.55	0.97
Bapineuzumab 1.0 mg/kgn=121 Participants	18.60	1.00
Placebon=153 Participants	17.54	0.86

Mean Difference (Final Values)1.0195% CI-1.55 - 3.57p0.437Mixed Models Analysis

Mean Difference (Final Values)1.0695% CI-1.54 - 3.66p0.423Mixed Models Analysis

Secondary/registry result

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

Time frame:39 Weeks

ADAS-Cog

descriptive

Posted result

Group	Value (mean), Units/Year	Standard error
Bapineuzumab 0.5 mg/kg - Placebon=583 Participants	-1.32	1.06
Bapineuzumab 1.0 mg/kg - Placebon=581 Participants	0.38	1.09

Mean Difference (Final Values)-1.3295% CI-3.40 - 0.76p0.212Mixed Models Analysis

Mean Difference (Final Values)0.3895% CI-1.76 - 2.52p0.725Mixed Models Analysis

Secondary/registry result

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

Time frame:78 Weeks

ADAS-Cog

time to event, event

Posted result

Group	Value (median), Days	Reported bounds
Bapineuzumab 0.5 mg/kgn=255 Participants	546.0	-546.0 - NA
Bapineuzumab 1.0 mg/kgn=253 Participants	462.0	-455.0 - 546.0
Placebon=328 Participants	540.0	-462.0 - 546.0

p0.030Log Rank

p0.567Log Rank

Secondary/registry result

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

Time frame:78 weeks

ADAS-Cog

time to event, event

Posted result

Group	Value (median), Days	Reported bounds
Bapineuzumab 0.5 mg/kgn=255 Participants	546.0	-546.0 - NA
Bapineuzumab 1.0 mg/kgn=253 Participants	546.0	-455.0 - 546.0
Placebon=328 Participants	546.0	-476.0 - 546.0

p0.079Log Rank

p0.675Log Rank

Secondary/registry result

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

Time frame:78 Weeks

ADAS-Cog

threshold achievement, improvement

Posted result

Group	Value (number), Number of participants	Reported bounds
Bapineuzumab 0.5 mg/kgWorsening of 0 pointsn=255 Participants	10.6	-7.1 - 15.0
Worsening of 3 pointsn=255 Participants	16.1	-11.8 - 21.2
Worsening of 7 pointsn=255 Participants	23.1	-18.1 - 28.8
Bapineuzumab 1.0 mg/kgWorsening of 0 pointsn=253 Participants	8.7	-5.5 - 12.9
Worsening of 3 pointsn=253 Participants	13.4	-9.5 - 18.3
Worsening of 7 pointsn=253 Participants	19.0	-14.3 - 24.4
PlaceboWorsening of 0 pointsn=328 Participants	7.3	-4.7 - 10.7
Worsening of 3 pointsn=328 Participants	10.1	-7.0 - 13.8
Worsening of 7 pointsn=328 Participants	19.2	-15.1 - 23.9

Secondary/registry result

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

Time frame:78 Weeks

ADAS-Cog

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Bapineuzumab 0.5 mg/kgn=255 Participants	22.4	-
Bapineuzumab 1.0 mg/kgn=253 Participants	18.6	-
Placebon=328 Participants	18.6	-

p0.277Cochran-Mantel-Haenszel

p0.996Cochran-Mantel-Haenszel

Secondary/registry result

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

Time frame: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
Bapineuzumab 0.5 mg/kgn=255 Participants	2.23	0.23
Bapineuzumab 1.0 mg/kgn=253 Participants	2.41	0.23
Placebon=328 Participants	2.59	0.20

Mean Difference (Final Values)-0.3695% CI-0.96 - 0.24p0.238Mixed Models Analysis

Change in CDR-SOB total score was analyzed using a REML based MMRM.

Mean Difference (Final Values)-0.1895% CI-0.78 - 0.43p0.564Mixed Models Analysis

Change in CDR-SOB total score was analyzed using a REML based MMRM.

Function / daily living

12 endpoints

Primary/protocol endpoint

The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78

Time frame:78 weeks

change from baseline, improvement

Primary/registry result

The Change From Baseline in the Disability Assessment for Demential (DAD) Total Score at Week 78

Time frame:78 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Bapineuzumab 0.5 mg/kgn=255 Participants	-14.58	1.50
Bapineuzumab 1.0 mg/kgn=253 Participants	-15.07	1.55
Placebon=328 Participants	-16.08	1.36

Mean Difference (Final Values)1.5195% CI-2.48 - 5.49p0.459Mixed Models Analysis

Mean Difference (Final Values)1.0195% CI-3.04 - 5.07p0.623Mixed Models Analysis

Secondary/protocol endpoint

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

Time frame:39 weeks

descriptive

Secondary/protocol endpoint

Time to Median Placebo Deterioration on DAD Total Score

Time frame:78 Weeks

time to event, event

Secondary/protocol endpoint

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

Time frame:78 Weeks

time to event, event

Secondary/protocol endpoint

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

Time frame:78 Weeks

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:78 weeks

threshold achievement, improvement

Secondary/registry result

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

Time frame:39 weeks

descriptive

Posted result

Group	Value (mean), Units/Years	Standard error
Bapineuzumab 0.5 mg/kg - Placebon=583 Participants	3.20	2.22
Bapineuzumab 1.0 mg/kg - Placebon=581 Participants	2.01	2.27

Mean Difference (Final Values)3.2095% CI-1.15 - 7.56p0.149Mixed Models Analysis

Mean Difference (Final Values)2.0195% CI-2.44 - 6.46p0.375Mixed Models Analysis

Secondary/registry result

Time to Median Placebo Deterioration on DAD Total Score

Time frame:78 Weeks

time to event, event

Posted result

Group	Value (median), Days	Reported bounds
Bapineuzumab 0.5 mg/kgn=255 Participants	541.0	-455.0 - 546.0
Bapineuzumab 1.0 mg/kgn=253 Participants	534.0	-372.0 - NA
Placebon=328 Participants	463.0	-453.0 - 546.0

p0.846Log Rank

Not spsecified.

p0.797Log Rank

Secondary/registry result

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

Time frame:78 Weeks

time to event, event

Posted result

Group	Value (median), Days	Reported bounds
Bapineuzumab 0.5 mg/kgn=255 Participants	542.0	-456.0 - 546.0
Bapineuzumab 1.0 mg/kgn=253 Participants	539.0	-450.0 - NA
Placebon=328 Participants	540.0	-453.0 - 546.0

p0.933Log Rank

p0.714Log Rank

Secondary/registry result

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

Time frame:78 Weeks

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Bapineuzumab 0.5 mg/kgWorsening of 0 pointsn=255 Participants	10.2	-6.8 - 14.6
Worsening of 6 pointsn=255 Participants	15.7	-11.4 - 20.7
Worsening of 12 pointsn=255 Participants	20.0	-15.3 - 25.4
Bapineuzumab 1.0 mg/kgWorsening of 0 pointsn=253 Participants	11.9	-8.1 - 16.5
Worsening of 6 pointsn=253 Participants	16.6	-12.2 - 21.8
Worsening of 12 pointsn=253 Participants	22.1	-17.2 - 27.8
PlaceboWorsening of 0 pointsn=328 Participants	9.1	-6.3 - 12.8
Worsening of 6 pointsn=328 Participants	14.3	-10.7 - 18.6
Worsening of 12 pointsn=328 Participants	19.5	-15.4 - 24.2

Secondary/registry result

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

Time frame:78 weeks

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	Reported bounds
Bapineuzumab 0.5 mg/kgn=255 Participants	20.0	-
Bapineuzumab 1.0 mg/kgn=253 Participants	22.1	-
Placebon=328 Participants	19.5	-

p0.855Cochran-Mantel-Haenszel

p0.423Cochran-Mantel-Haenszel

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

The Change From Baseline in Brain Amyloid Burden at Week 71.

Time frame:71 Weeks

change from baseline, improvement

Secondary/registry result

The Change From Baseline in Brain Amyloid Burden at Week 71.

Time frame:71 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), SUVr	Standard error
Bapineuzumab 0.5 mg/kgn=6 Participants	-0.04	0.08
Bapineuzumab 1.0 mg/kgn=11 Participants	0.00	0.05
Placebon=13 Participants	0.02	0.04
Pooled Bapineuzumab 0.5/1.0 mg/kgn=17 Participants	-0.01	0.04

Mean Difference (Final Values)-0.0395% CI-0.15 - 0.09p0.654Mixed Models Analysis

Tau biomarkers

2 endpoints

Secondary/protocol endpoint

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

Time frame:71 Weeks

change from baseline, improvement

Secondary/registry result

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

Time frame:71 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Bapineuzumab 0.5 mg/kgn=21 Participants	-6.62	3.90
Bapineuzumab 1.0 mg/kgn=22 Participants	-6.35	3.73
Placebon=33 Participants	0.70	3.03
Pooled Bapineuzumab 0.5/1.0 mg/kgn=43 Participants	-6.48	2.67

Mean Difference (Final Values)-7.1895% CI-15.38 - 1.02p0.085ANCOVA

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Dependence Scale Total Score at Week 78

Time frame:78 Weeks

change from baseline, improvement

Secondary/registry result

Change From Baseline in Dependence Scale Total Score at Week 78

Time frame:78 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Bapineuzumab 0.5 mg/kgn=255 Participants	1.29	0.19
Bapineuzumab 1.0 mg/kgn=253 Participants	1.16	0.19
Placebon=328 Participants	1.45	0.17

Mean Difference (Final Values)-0.1695% CI-0.65 - 0.33p0.516Mixed Models Analysis

Change in DS score was analyzed using a REML based MMRM.

Mean Difference (Final Values)-0.2995% CI-0.79 - 0.21p0.257Mixed Models Analysis

Change in DS score was analyzed using a REML based MMRM.

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.