TerminatedPhase 3Results posted

A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients

A Phase 3 Extension, Multicenter, Long Term Safety And Tolerability Trial Of Bapineuzumab (Aab 001, Eln115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E 4 Carriers And Participated In Study 3133k1-3001-us Or Study 3133k1-3001-ww.

Lead sponsor

Pfizer

Asset

Bapineuzumab

Listed sites

184

Recruiting sites

Enrollment

494

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≥10

Primary endpoint

•Serious Adverse Event

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 number2009-015080-13

Org study ID3133K1-3003

Secondary IDB2521004Alias Study Number

NCT IDNCT00998764

Timeline

Milestones

Study first posted2009-10-20estimated

Study start2009-12 (month precision)

Primary completion2012-10actual (month precision)

Study completion2012-11actual (month precision)

Last update posted2016-01-01estimated

Results first posted2016-01-01estimated

Assets

Drug assets

Bapineuzumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age51 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subject has completed study 3133K1-3001 (Week 78) and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease

•Mini-Mental Status Examination (MMSE) >=10 at screening

•Caregiver able to attend all clinic visits with subject

Exclusion criteria

•Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.

•Any significant brain MRI abnormality.

•Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening

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

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Global cognition

8 endpoints

Secondary/protocol endpoint

Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78

Time frame:Base Study Baseline, Weeks 13, 26, 39, 52 and 78

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.

Time frame:Base Study Baseline, Weeks 13, 26, 39, 52 and 78

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.

Time frame:Base Study Baseline, Weeks 6, 19, 32, 45 and 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.

Time frame:Base Study Baseline, Weeks 6, 19, 32, 45 and 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78

Time frame:Base Study Baseline, Weeks 13, 26, 39, 52 and 78

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/BapineuzumabWeek 13 (N= 197, 253)n=199 Participants	5.53	0.57
Week 26 (N = 154, 221)n=199 Participants	7.41	0.63
Week 39 (N = 121, 184)n=199 Participants	8.83	0.72
Week 52 (N = 91, 139)n=199 Participants	10.12	0.75
Week 78 (N = 52, 80)n=199 Participants	13.91	0.96
Bapineuzumab/BapineuzumabWeek 13 (N= 197, 253)n=256 Participants	6.28	0.50
Week 26 (N = 154, 221)n=256 Participants	7.70	0.54
Week 39 (N = 121, 184)n=256 Participants	8.87	0.61
Week 52 (N = 91, 139)n=256 Participants	10.11	0.63
Week 78 (N = 52, 80)n=256 Participants	12.70	0.80

Mean Difference (Final Values)0.7495% CI-0.74 - 2.23p0.324Mixed Models Analysis

Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 13

Mean Difference (Final Values)0.2995% CI-1.33 - 1.92p0.723Mixed Models Analysis

Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 26

Mean Difference (Final Values)0.0495% CI-1.81 - 1.89p0.966Mixed Models Analysis

Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 39

Mean Difference (Final Values)0.0095% CI-1.93 - 1.92p0.996Mixed Models Analysis

Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 52

Mean Difference (Final Values)-1.2195% CI-3.67 - 1.26p0.336Mixed Models Analysis

Change from baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog) at week 78

Secondary/registry result

Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.

Time frame:Base Study Baseline, Weeks 13, 26, 39, 52 and 78

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/BapineuzumabWeek 13 (N = 197, 253)n=199 Participants	0.89	0.36
Week 26 (N = 154, 221)n=199 Participants	2.87	0.42
Week 39 (N = 121, 184)n=199 Participants	4.26	0.50
Week 52 (N = 91, 139)n=199 Participants	5.42	0.55
Week 78 (N = 52, 80)n=199 Participants	9.21	0.82
Bapineuzumab/BapineuzumabWeek 13 (N = 197, 253)n=256 Participants	0.73	0.32
Week 26 (N = 154, 221)n=256 Participants	2.19	0.35
Week 39 (N = 121, 184)n=256 Participants	3.35	0.42
Week 52 (N = 91, 139)n=256 Participants	4.51	0.45
Week 78 (N = 52, 80)n=256 Participants	7.07	0.66

Mean Difference (Final Values)-0.1695% CI-1.11 - 0.79p0.737Mixed Models Analysis

Change from extension study baseline in ADAS-Cog at week 13

Mean Difference (Final Values)-0.6895% CI-1.76 - 0.40p0.213Mixed Models Analysis

Change from extension study baseline in ADAS-Cog at week 26

Mean Difference (Final Values)-0.9095% CI-2.19 - 0.38p0.168Mixed Models Analysis

Change from extension study baseline in ADAS-Cog at week 39

Mean Difference (Final Values)-0.9195% CI-2.30 - 0.48p0.197Mixed Models Analysis

Change from extension study baseline in ADAS-Cog at week 52

Mean Difference (Final Values)-2.1395% CI-4.21 - 0.06p0.044Mixed Models Analysis

Change from extension study baseline in ADAS-Cog at week 78

Secondary/registry result

Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.

Time frame:Base Study Baseline, Weeks 6, 19, 32, 45 and 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/BapineuzumabWeek 6 (N= 197, 255)n=199 Participants	-2.61	0.22
Week 19 (N = 184, 241)n=199 Participants	-3.13	0.22
Week 32 (N = 141, 204)n=199 Participants	-3.75	0.24
Week 45 (N = 117, 171)n=199 Participants	-4.44	0.26
Week 78 (N = 65, 94)n=199 Participants	-5.50	0.32
Bapinezumab/BapinezumabWeek 6 (N= 197, 255)n=256 Participants	-2.55	0.19
Week 19 (N = 184, 241)n=256 Participants	-3.01	0.19
Week 32 (N = 141, 204)n=256 Participants	-3.65	0.20
Week 45 (N = 117, 171)n=256 Participants	-4.26	0.21
Week 78 (N = 65, 94)n=256 Participants	-5.54	0.26

Mean Difference (Final Values)0.0795% CI-0.49 - 0.63p0.811Mixed Models Analysis

Change from base study baseline in MMSE score at Week 6.

Mean Difference (Final Values)0.1295% CI-0.45 - 0.69p0.681Mixed Models Analysis

Change from base study baseline in MMSE score at Week 19.

Mean Difference (Final Values)0.1095% CI-0.51 - 0.72p0.742Mixed Models Analysis

Change from extension study baseline in MMSE score at Week 32.

Mean Difference (Final Values)0.1895% CI-0.48 - 0.83p0.598Mixed Models Analysis

Change from extension study baseline in MMSE score at Week 45.

Mean Difference (Final Values)-0.0495% CI-0.85 - 0.77p0.922Mixed Models Analysis

Change from extension study baseline in MMSE score at Week 78.

Secondary/registry result

Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.

Time frame:Base Study Baseline, Weeks 6, 19, 32, 45 and 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/BapineuzumabWeek 6 (N = 195, 255)n=199 Participants	-0.67	0.19
Week 19 (N = 182, 241)n=199 Participants	-1.16	0.21
Week 32 (N = 140, 204)n=199 Participants	-1.85	0.24
Week 45 (N = 116, 171)n=199 Participants	-2.57	0.28
Week 78 (N = 64, 94)n=199 Participants	-3.69	0.39
Bapinezumab/BapinezumabWeek 6 (N = 195, 255)n=256 Participants	-0.26	0.16
Week 19 (N = 182, 241)n=256 Participants	-0.69	0.18
Week 32 (N = 140, 204)n=256 Participants	-1.40	0.20
Week 45 (N = 116, 171)n=256 Participants	-2.05	0.24
Week 78 (N = 64, 94)n=256 Participants	-3.42	0.32

Mean Difference (Final Values)0.4195% CI-0.08 - 0.90p0.099Mixed Models Analysis

Change from extension study baseline in MMSE score at Week 6.

Mean Difference (Final Values)0.4795% CI-0.07 - 1.01p0.089Mixed Models Analysis

Change from extension study baseline in MMSE score at Week 19.

Mean Difference (Final Values)0.4595% CI-0.17 - 1.08p0.152Mixed Models Analysis

Change from extension study baseline in MMSE score at Week 32.

Mean Difference (Final Values)0.5295% CI-0.21 - 1.25p0.160Mixed Models Analysis

Change from extension study baseline in MMSE score at Week 45.

Mean Difference (Final Values)0.2695% CI-0.73 - 1.26p0.603Mixed Models Analysis

Change from extension study baseline in MMSE score at Week 78.

Function / daily living

4 endpoints

Secondary/protocol endpoint

Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.

Time frame:Base Study Baseline, Weeks 13, 26, 39, 52 and 78

change from baseline, improvement

Secondary/protocol endpoint

Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.

Time frame:Base Study Baseline, Weeks 13, 26, 39, 52 and 78

change from baseline, improvement

Secondary/registry result

Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.

Time frame:Base Study Baseline, Weeks 13, 26, 39, 52 and 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/BapineuzumabWeek 13 (N = 194, 247)n=199 Participants	-12.33	1.27
Week 26 (N = 151, 222)n=199 Participants	-15.37	1.29
Week 39 (N = 119, 180)n=199 Participants	-17.74	1.47
Week 52 (N = 89, 137)n=199 Participants	-20.96	1.65
Week 78 (N = 50, 81)n=199 Participants	-26.33	2.18
Bapinezumab/BapinezumabWeek 13 (N = 194, 247)n=256 Participants	15.32	1.11
Week 26 (N = 151, 222)n=256 Participants	-18.04	1.11
Week 39 (N = 119, 180)n=256 Participants	-21.33	1.24
Week 52 (N = 89, 137)n=256 Participants	-22.72	1.36
Week 78 (N = 50, 81)n=256 Participants	-29.11	1.75

Mean Difference (Final Values)-2.9995% CI-6.30 - 0.33p0.077Mixed Models Analysis

Change from base study baseline in DAD score at Week 13

Mean Difference (Final Values)-2.6795% CI-6.02 - 0.67p0.117Mixed Models Analysis

Change from base study baseline in DAD score at Week 26

Mean Difference (Final Values)-3.6095% CI-7.38 - 0.19p0.063Mixed Models Analysis

Change from base study baseline in DAD score at Week 39

Mean Difference (Final Values)-1.7595% CI-5.95 - 2.44p0.412Mixed Models Analysis

Change from base study baseline in DAD score at Week 52

Mean Difference (Final Values)-2.7895% CI-8.28 - 2.73p0.321Mixed Models Analysis

Change from base study baseline in DAD score at Week 78

Secondary/registry result

Change From Extension Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.

Time frame:Base Study Baseline, Weeks 13, 26, 39, 52 and 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on scale	Standard error
Placebo/BapineuzumabWeek 13 (N = 194, 247)n=199 Participants	-2.63	0.83
Week 26 (N = 151, 222)n=199 Participants	-5.76	1.01
Week 39 (N = 119, 180)n=199 Participants	-8.17	1.22
Week 52 (N = 89, 137)n=199 Participants	-11.82	1.34
Week 78 (N = 50, 81)n=199 Participants	-17.34	1.94
Bapinezumab/BapinezumabWeek 13 (N = 194, 247)n=256 Participants	-3.71	0.73
Week 26 (N = 151, 222)n=256 Participants	-6.46	0.86
Week 39 (N = 119, 180)n=256 Participants	-9.72	1.02
Week 52 (N = 89, 137)n=256 Participants	-11.11	1.10
Week 78 (N = 50, 81)n=256 Participants	-17.48	1.56

Mean Difference (Final Values)-1.0895% CI-3.24 - 1.09p0.329Mixed Models Analysis

Change from extension study baseline in DAD score at Week 13

Mean Difference (Final Values)-0.7095% CI-3.31 - 1.92p0.601Mixed Models Analysis

Change from extension study baseline in DAD score at Week 26

Mean Difference (Final Values)-1.5595% CI-4.67 - 1.56p0.328Mixed Models Analysis

Change from extension study baseline in DAD score at Week 39

Mean Difference (Final Values)0.7195% CI-2.70 - 4.13p0.680Mixed Models Analysis

Change from extension study baseline in DAD score at Week 52

Mean Difference (Final Values)-0.1495% CI-5.05 - 4.77p0.954Mixed Models Analysis

Change from extension study baseline in DAD score at Week 78

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.

Time frame:Base Study Baseline, Weeks 26, 52 and 78

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.

Time frame:Base Study Baseline, Weeks 26, 52 and 78

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.

Time frame:Base Study Baseline, Weeks 26, 52 and 78

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/BapineuzumabWeek 26 (N = 176, 240)n=199 Participants	2.84	0.97
Week 52 (N = 110, 163)n=199 Participants	4.32	0.96
Week 78 (N = 51, 81)n=199 Participants	6.95	1.70
Bapinezumab/BapinezumabWeek 26 (N = 176, 240)n=256 Participants	2.95	0.83
Week 52 (N = 110, 163)n=256 Participants	3.52	0.80
Week 78 (N = 51, 81)n=256 Participants	4.93	1.36

Mean Difference (Final Values)0.1195% CI-2.40 - 2.62p0.931Mixed Models Analysis

Change from base study baseline in NPI score at week 26.

Mean Difference (Final Values)-0.8095% CI-3.26 - 1.67p0.524Mixed Models Analysis

Change from base study baseline in NPI score at week 52.

Mean Difference (Final Values)-2.0395% CI-6.32 - 2.27p0.353Mixed Models Analysis

Change from base study baseline in NPI score at week 78.

Secondary/registry result

Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.

Time frame:Base Study Baseline, Weeks 26, 52 and 78

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/BapineuzumabWeek 26 (N = 176, 240)n=199 Participants	2.17	0.86
Week 52 (N = 110, 163)n=199 Participants	3.82	0.95
Week 78 (N = 51, 81)n=199 Participants	6.60	1.69
Bapinezumab/BapinezumabWeek 26 (N = 176, 240)n=256 Participants	1.47	0.73
Week 52 (N = 110, 163)n=256 Participants	1.98	0.79
Week 78 (N = 51, 81)n=256 Participants	3.29	1.35

Mean Difference (Final Values)-0.7195% CI-2.92 - 1.51p0.531Mixed Models Analysis

Change from extension study baseline in NPI score at week 26.

Mean Difference (Final Values)-1.8495% CI-4.28 - 0.59p0.137Mixed Models Analysis

Change from extension study baseline in NPI score at week 52.

Mean Difference (Final Values)-3.3295% CI-7.60 - 0.96p0.128Mixed Models Analysis

Change from extension study baseline in NPI score at week 78.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Participants Reporting a Serious Adverse Event

Time frame:Up to Week 195

event count, event

Primary/registry result

Number of Participants Reporting a Serious Adverse Event

Time frame:Up to Week 195

event count, event

Posted result

Group	Value (number), Number of Participants	Reported bounds
Placebo/Bapineuzumabn=215 Participants	35	-
Bapineuzumab/Bapineuzumabn=275 Participants	33	-

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

Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y.
PMID27334799via 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.