TerminatedPhase 3Results posted

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

A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety And Tolerability Trial Of Bapineuzumab (AAB-001, ELN115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Noncarriers And Participated In Study 3133K1-3000

Lead sponsor

Pfizer

Asset

Bapineuzumab

Listed sites

Recruiting sites

Enrollment

198

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

Org study ID3133K1-3002

SecondaryB2521003

NCT IDNCT00996918

Timeline

Milestones

Study first posted2009-10-16estimated

Study start2009-12 (month precision)

Primary completion2012-11actual (month precision)

Study completion2012-11actual (month precision)

Last update posted2014-01-01estimated

Results first posted2014-01-01estimated

Assets

Drug assets

Bapineuzumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age51 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Subject has completed study 3133K1-3000 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: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: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:Weeks 6, 19, 32, 45 and 78

Mini-Mental State Examination (MMSE)

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Weeks 6, 19, 32, 45 and 78

Mini-Mental State Examination (MMSE)

concentration, descriptive

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: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/Bapineuzumab 0.5 mg/kgWeek 13 (N = 38, 62, 33, 53)n=38 Participants	7.47	1.17
Week 26 (N = 33, 54, 26, 45)n=38 Participants	9.00	1.27
Week 39 (N = 25, 46, 22, 37)n=38 Participants	9.74	1.35
Week 52 (N = 18, 32, 15, 29)n=38 Participants	12.44	1.70
Week 78 (N = 12, 19, 8, 20)n=38 Participants	14.71	2.12
Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kgWeek 13 (N = 38, 62, 33, 53)n=62 Participants	6.17	0.95
Week 26 (N = 33, 54, 26, 45)n=62 Participants	7.49	1.03
Week 39 (N = 25, 46, 22, 37)n=62 Participants	8.79	1.08
Week 52 (N = 18, 32, 15, 29)n=62 Participants	10.38	1.35
Week 78 (N = 12, 19, 8, 20)n=62 Participants	12.27	1.81
Placebo/Bapineuzumab 1.0 mg/kgWeek 13 (N = 38, 62, 33, 53)n=33 Participants	4.66	1.26
Week 26 (N = 33, 54, 26, 45)n=33 Participants	7.34	1.38
Week 39 (N = 25, 46, 22, 37)n=33 Participants	7.92	1.45
Week 52 (N = 18, 32, 15, 29)n=33 Participants	10.54	1.82
Week 78 (N = 12, 19, 8, 20)n=33 Participants	15.46	2.46
Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kgWeek 13 (N = 38, 62, 33, 53)n=53 Participants	6.45	0.98
Week 26 (N = 33, 54, 26, 45)n=53 Participants	7.30	1.07
Week 39 (N = 25, 46, 22, 37)n=53 Participants	9.50	1.12
Week 52 (N = 18, 32, 15, 29)n=53 Participants	10.31	1.36
Week 78 (N = 12, 19, 8, 20)n=53 Participants	15.31	1.68

Mean Difference (Final Values)-1.3095% CI-4.29 - 1.68p0.390Mixed Models Analysis

Mean Difference (Final Values)1.8095% CI-1.37 - 4.97p0.264Mixed Models Analysis

Mean Difference (Final Values)-1.5195% CI-4.74 - 1.72p0.357Mixed Models Analysis

Mean Difference (Final Values)-0.0495% CI-3.50 - 3.42p0.981Mixed Models Analysis

Mean Difference (Final Values)-0.9595% CI-4.37 - 2.47p0.584Mixed Models Analysis

Mean Difference (Final Values)1.5895% CI-2.05 - 5.20p0.392Mixed Models Analysis

Mean Difference (Final Values)-2.0595% CI-6.34 - 2.24p0.345Mixed Models Analysis

Mean Difference (Final Values)-0.2295% CI-4.73 - 4.28p0.922Mixed Models Analysis

Mean Difference (Final Values)-2.4495% CI-7.97 - 3.10p0.384Mixed Models Analysis

Mean Difference (Final Values)-0.1595% CI-6.08 - 5.78p0.961Mixed Models Analysis

Secondary/registry result

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

Time frame: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/Bapineuzumab 0.5 mg/kgWeek 13 (N = 38, 62, 33, 53)n=38 Participants	0.10	0.84
Week 26 (N = 33, 54, 26, 45)n=38 Participants	1.61	0.92
Week 39 (N = 25, 46, 22, 37)n=38 Participants	2.35	1.01
Week 52 (N = 18, 32, 15, 29)n=38 Participants	4.85	1.45
Week 78 (N = 12, 19, 8, 20)n=38 Participants	7.29	1.81
Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kgWeek 13 (N = 38, 62, 33, 53)n=62 Participants	0.32	0.68
Week 26 (N = 33, 54, 26, 45)n=62 Participants	1.63	0.75
Week 39 (N = 25, 46, 22, 37)n=62 Participants	2.86	0.79
Week 52 (N = 18, 32, 15, 29)n=62 Participants	4.45	1.14
Week 78 (N = 12, 19, 8, 20)n=62 Participants	6.73	1.57
Placebo/Bapineuzumab 1.0 mg/kgWeek 13 (N = 38, 62, 33, 53)n=33 Participants	-1.68	0.90
Week 26 (N = 33, 54, 26, 45)n=33 Participants	1.08	1.01
Week 39 (N = 25, 46, 22, 37)n=33 Participants	1.68	1.07
Week 52 (N = 18, 32, 15, 29)n=33 Participants	4.30	1.55
Week 78 (N = 12, 19, 8, 20)n=33 Participants	8.86	2.15
Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kgWeek 13 (N = 38, 62, 33, 53)n=53 Participants	0.46	0.70
Week 26 (N = 33, 54, 26, 45)n=53 Participants	1.37	0.78
Week 39 (N = 25, 46, 22, 37)n=53 Participants	3.62	0.83
Week 52 (N = 18, 32, 15, 29)n=53 Participants	4.43	1.14
Week 78 (N = 12, 19, 8, 20)n=53 Participants	9.68	1.42

Mean Difference (Final Values)0.2295% CI-1.91 - 2.35p0.837Mixed Models Analysis

Mean Difference (Final Values)2.1495% CI-0.13 - 4.41p0.064Mixed Models Analysis

Mean Difference (Final Values)0.0195% CI-2.32 - 2.35p0.990Mixed Models Analysis

Mean Difference (Final Values)0.3095% CI-2.22 - 2.82p0.817Mixed Models Analysis

Mean Difference (Final Values)0.5095% CI-2.04 - 3.05p0.697Mixed Models Analysis

Mean Difference (Final Values)1.9395% CI-0.76 - 4.63p0.158Mixed Models Analysis

Mean Difference (Final Values)-0.4095% CI-4.06 - 3.26p0.829Mixed Models Analysis

Mean Difference (Final Values)0.1295% CI-3.69 - 3.93p0.950Mixed Models Analysis

Mean Difference (Final Values)-0.5695% CI-5.35 - 4.23p0.816Mixed Models Analysis

Mean Difference (Final Values)0.8295% CI-4.32 - 5.96p0.751Mixed Models Analysis

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:Weeks 6, 19, 32, 45 and 78

Mini-Mental State Examination (MMSE)

concentration, descriptive

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/Bapineuzumab 0.5 mg/kgWeek 6 (N = 38, 61, 33, 53)n=38 Participants	-2.89	0.46
Week 19 (N = 36, 59, 28, 50)n=38 Participants	-2.80	0.47
Week 32 (N = 32, 51, 26, 41)n=38 Participants	-3.82	0.49
Week 45 (N = 23, 41, 21, 35)n=38 Participants	-4.86	0.56
Week 78 (N = 13, 27, 11, 21)n=38 Participants	-7.62	0.70
Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kgWeek 6 (N = 38, 61, 33, 53)n=62 Participants	-2.85	0.37
Week 19 (N = 36, 59, 28, 50)n=62 Participants	-2.66	0.38
Week 32 (N = 32, 51, 26, 41)n=62 Participants	-3.43	0.40
Week 45 (N = 23, 41, 21, 35)n=62 Participants	-4.13	0.44
Week 78 (N = 13, 27, 11, 21)n=62 Participants	-5.10	0.54
Placebo/Bapineuzumab 1.0 mg/kgWeek 6 (N = 38, 61, 33, 53)n=33 Participants	-2.02	0.49
Week 19 (N = 36, 59, 28, 50)n=33 Participants	-2.76	0.51
Week 32 (N = 32, 51, 26, 41)n=33 Participants	-4.40	0.53
Week 45 (N = 23, 41, 21, 35)n=33 Participants	-4.63	0.58
Week 78 (N = 13, 27, 11, 21)n=33 Participants	-6.97	0.75
Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kgWeek 6 (N = 38, 61, 33, 53)n=53 Participants	-2.22	0.39
Week 19 (N = 36, 59, 28, 50)n=53 Participants	-3.29	0.39
Week 32 (N = 32, 51, 26, 41)n=53 Participants	-3.88	0.42
Week 45 (N = 23, 41, 21, 35)n=53 Participants	-4.51	0.46
Week 78 (N = 13, 27, 11, 21)n=53 Participants	-4.89	0.56

Mean Difference (Final Values)0.0595% CI-1.12 - 1.21p0.938Mixed Models Analysis

Mean Difference (Final Values)-0.2095% CI-1.43 - 1.04p0.753Mixed Models Analysis

Mean Difference (Final Values)0.1595% CI-1.04 - 1.33p0.809Mixed Models Analysis

Mean Difference (Final Values)-0.5295% CI-1.80 - 0.75p0.421Mixed Models Analysis

Mean Difference (Final Values)0.3995% CI-0.85 - 1.63p0.535Mixed Models Analysis

Mean Difference (Final Values)0.5295% CI-0.82 - 1.86p0.445Mixed Models Analysis

Mean Difference (Final Values)0.7395% CI-0.67 - 2.12p0.309Mixed Models Analysis

Mean Difference (Final Values)0.1295% CI-1.34 - 1.57p0.872Mixed Models Analysis

Mean Difference (Final Values)2.5295% CI0.79 - 4.26p0.004Mixed Models Analysis

Mean Difference (Final Values)2.0995% CI0.25 - 3.93p0.026Mixed Models Analysis

Secondary/registry result

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

Time frame:Weeks 6, 19, 32, 45 and 78

Mini-Mental State Examination (MMSE)

concentration, descriptive

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/Bapineuzumab 0.5 mg/kgWeek 6 (N = 38, 61, 33, 53)n=38 Participants	-1.20	0.46
Week 19 (N = 36, 59, 28, 50)n=38 Participants	-1.10	0.47
Week 32 (N = 32, 51, 26, 41)n=38 Participants	-2.11	0.49
Week 45 (N = 23, 41, 21, 35)n=38 Participants	-3.06	0.56
Week 78 (N = 13, 27, 11, 21)n=38 Participants	-5.68	0.71
Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kgWeek 6 (N = 38, 61, 33, 53)n=62 Participants	-0.80	0.38
Week 19 (N = 36, 59, 28, 50)n=62 Participants	-0.64	0.38
Week 32 (N = 32, 51, 26, 41)n=62 Participants	-1.45	0.40
Week 45 (N = 23, 41, 21, 35)n=62 Participants	-2.13	0.45
Week 78 (N = 13, 27, 11, 21)n=62 Participants	-3.22	0.54
Placebo/Bapineuzumab 1.0 mg/kgWeek 6 (N = 38, 61, 33, 53)n=33 Participants	0.11	0.50
Week 19 (N = 36, 59, 28, 50)n=33 Participants	-0.62	0.52
Week 32 (N = 32, 51, 26, 41)n=33 Participants	-2.18	0.54
Week 45 (N = 23, 41, 21, 35)n=33 Participants	-2.39	0.59
Week 78 (N = 13, 27, 11, 21)n=33 Participants	-4.73	0.77
Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kgWeek 6 (N = 38, 61, 33, 53)n=53 Participants	-0.23	0.39
Week 19 (N = 36, 59, 28, 50)n=53 Participants	-1.32	0.39
Week 32 (N = 32, 51, 26, 41)n=53 Participants	-1.93	0.42
Week 45 (N = 23, 41, 21, 35)n=53 Participants	-2.62	0.46
Week 78 (N = 13, 27, 11, 21)n=53 Participants	-2.97	0.56

Mean Difference (Final Values)0.4095% CI-0.77 - 1.57p0.504Mixed Models Analysis

Mean Difference (Final Values)-0.3495% CI-1.58 - 0.90p0.592Mixed Models Analysis

Mean Difference (Final Values)0.4795% CI-0.72 - 1.65p0.441Mixed Models Analysis

Mean Difference (Final Values)-0.6995% CI-1.97 - 0.59p0.288Mixed Models Analysis

Mean Difference (Final Values)0.6695% CI-0.59 - 1.90p0.303Mixed Models Analysis

Mean Difference (Final Values)0.2595% CI-1.09 - 1.60p0.713Mixed Models Analysis

Mean Difference (Final Values)0.9395% CI-0.49 - 2.34p0.198Mixed Models Analysis

Mean Difference (Final Values)-0.2395% CI-1.70 - 1.24p0.756Mixed Models Analysis

Mean Difference (Final Values)2.4595% CI0.69 - 4.22p0.006Mixed Models Analysis

Mean Difference (Final Values)1.7595% CI-0.12 - 3.62p0.066Mixed Models Analysis

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:Weeks 13, 26, 39, 52 and 78

change from baseline, improvement

Secondary/protocol endpoint

Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78

Time frame: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: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/Bapineuzumab 0.5 mg/kgWeek 13 (N = 38, 62, 31, 52)n=38 Participants	-18.75	2.88
Week 26 (N = 33, 56, 26, 44)n=38 Participants	-21.19	2.93
Week 39 (N = 25, 46, 21, 37)n=38 Participants	-25.42	3.14
Week 52 (N = 18, 32, 15, 30)n=38 Participants	-29.52	3.48
Week 78 (N = 12, 20, 8, 20)n=38 Participants	-36.48	4.56
Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kgWeek 13 (N = 38, 62, 31, 52)n=62 Participants	-18.60	2.36
Week 26 (N = 33, 56, 26, 44)n=62 Participants	-21.04	2.38
Week 39 (N = 25, 46, 21, 37)n=62 Participants	-27.36	2.51
Week 52 (N = 18, 32, 15, 30)n=62 Participants	-28.00	2.77
Week 78 (N = 12, 20, 8, 20)n=62 Participants	-35.75	3.79
Placebo/Bapineuzumab 1.0 mg/kgWeek 13 (N = 38, 62, 31, 52)n=33 Participants	-15.50	3.13
Week 26 (N = 33, 56, 26, 44)n=33 Participants	-16.26	3.19
Week 39 (N = 25, 46, 21, 37)n=33 Participants	-14.57	3.39
Week 52 (N = 18, 32, 15, 30)n=33 Participants	-20.41	3.74
Week 78 (N = 12, 20, 8, 20)n=33 Participants	-25.21	5.24
Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kgWeek 13 (N = 38, 62, 31, 52)n=53 Participants	-13.36	2.43
Week 26 (N = 33, 56, 26, 44)n=53 Participants	-19.18	2.48
Week 39 (N = 25, 46, 21, 37)n=53 Participants	-19.10	2.62
Week 52 (N = 18, 32, 15, 30)n=53 Participants	-23.21	2.80
Week 78 (N = 12, 20, 8, 20)n=53 Participants	-30.28	3.65

Mean Difference (Final Values)0.1695% CI-7.22 - 7.53p0.967Mixed Models Analysis

Mean Difference (Final Values)2.1395% CI-5.72 - 9.98p0.593Mixed Models Analysis

Mean Difference (Final Values)0.1595% CI-7.32 - 7.62p0.968Mixed Models Analysis

Mean Difference (Final Values)-2.9295% CI-10.92 - 5.08p0.473Mixed Models Analysis

Mean Difference (Final Values)-1.9595% CI-9.91 - 6.02p0.630Mixed Models Analysis

Mean Difference (Final Values)-4.5395% CI-13.02 - 3.95p0.293Mixed Models Analysis

Mean Difference (Final Values)1.5395% CI-7.28 - 10.33p0.733Mixed Models Analysis

Mean Difference (Final Values)-2.8195% CI-12.06 - 6.45p0.550Mixed Models Analysis

Mean Difference (Final Values)0.7395% CI-11.04 - 12.50p0.902Mixed Models Analysis

Mean Difference (Final Values)-5.0795% CI-17.75 - 7.61p0.430Mixed Models Analysis

Secondary/registry result

Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78

Time frame: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/Bapineuzumab 0.5 mg/kgWeek 13 (N = 38, 62, 31, 52)n=38 Participants	-3.80	1.96
Week 26 (N = 33, 56, 26, 44)n=38 Participants	-6.33	2.02
Week 39 (N = 25, 46, 21, 37)n=38 Participants	-11.14	2.23
Week 52 (N = 18, 32, 15, 30)n=38 Participants	-16.21	2.57
Week 78 (N = 12, 20, 8, 20)n=38 Participants	-23.40	3.01
Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kgWeek 13 (N = 38, 62, 31, 52)n=62 Participants	-4.83	1.60
Week 26 (N = 33, 56, 26, 44)n=62 Participants	-7.22	1.64
Week 39 (N = 25, 46, 21, 37)n=62 Participants	-13.49	1.76
Week 52 (N = 18, 32, 15, 30)n=62 Participants	-13.77	2.02
Week 78 (N = 12, 20, 8, 20)n=62 Participants	-21.30	2.54
Placebo/Bapineuzumab 1.0 mg/kgWeek 13 (N = 38, 62, 31, 52)n=33 Participants	-5.17	2.16
Week 26 (N = 33, 56, 26, 44)n=33 Participants	-5.75	2.23
Week 39 (N = 25, 46, 21, 37)n=33 Participants	-4.34	2.41
Week 52 (N = 18, 32, 15, 30)n=33 Participants	-10.02	2.75
Week 78 (N = 12, 20, 8, 20)n=33 Participants	-14.54	3.54
Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kgWeek 13 (N = 38, 62, 31, 52)n=53 Participants	-1.48	1.65
Week 26 (N = 33, 56, 26, 44)n=53 Participants	-7.25	1.73
Week 39 (N = 25, 46, 21, 37)n=53 Participants	-7.08	1.85
Week 52 (N = 18, 32, 15, 30)n=53 Participants	-11.06	2.02
Week 78 (N = 12, 20, 8, 20)n=53 Participants	-17.41	2.37

Mean Difference (Final Values)-1.0395% CI-6.01 - 3.95p0.683Mixed Models Analysis

Mean Difference (Final Values)3.6995% CI-1.68 - 9.06p0.177Mixed Models Analysis

Mean Difference (Final Values)-0.8995% CI-6.03 - 4.25p0.734Mixed Models Analysis

Mean Difference (Final Values)-1.5095% CI-7.06 - 4.05p0.595Mixed Models Analysis

Mean Difference (Final Values)-2.3595% CI-7.95 - 3.24p0.409Mixed Models Analysis

Mean Difference (Final Values)-2.7495% CI-8.73 - 3.24p0.368Mixed Models Analysis

Mean Difference (Final Values)2.4495% CI-4.01 - 8.89p0.458Mixed Models Analysis

Mean Difference (Final Values)-1.0495% CI-7.77 - 5.68p0.760Mixed Models Analysis

Mean Difference (Final Values)2.0995% CI-5.67 - 9.86p0.597Mixed Models Analysis

Mean Difference (Final Values)-2.8795% CI-11.24 - 5.50p0.501Mixed Models Analysis

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:Weeks 26, 52 and 78

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

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

Time frame:Weeks 26, 52 and 78

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/registry result

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

Time frame:Weeks 26, 52 and 78

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/Bapineuzumab 0.5 mg/kgWeek 26 (N = 36, 59, 30, 51)n=38 Participants	4.57	2.08
Week 52 (N = 21, 37, 17, 32)n=38 Participants	4.99	2.60
Week 78 (N = 13, 18, 8, 20)n=38 Participants	16.17	3.23
Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kgWeek 26 (N = 36, 59, 30, 51)n=62 Participants	0.97	1.70
Week 52 (N = 21, 37, 17, 32)n=62 Participants	-0.01	2.05
Week 78 (N = 13, 18, 8, 20)n=62 Participants	3.31	2.94
Placebo/Bapineuzumab 1.0 mg/kgWeek 26 (N = 36, 59, 30, 51)n=33 Participants	4.71	2.26
Week 52 (N = 21, 37, 17, 32)n=33 Participants	4.23	2.80
Week 78 (N = 13, 18, 8, 20)n=33 Participants	5.24	4.02
Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kgWeek 26 (N = 36, 59, 30, 51)n=53 Participants	4.43	1.75
Week 52 (N = 21, 37, 17, 32)n=53 Participants	6.57	2.08
Week 78 (N = 13, 18, 8, 20)n=53 Participants	6.70	2.61

Mean Difference (Final Values)-3.6095% CI-8.91 - 1.71p0.183Mixed Models Analysis

Mean Difference (Final Values)-0.2995% CI-5.92 - 5.35p0.920Mixed Models Analysis

Mean Difference (Final Values)-4.9995% CI-11.52 - 1.53p0.133Mixed Models Analysis

Mean Difference (Final Values)2.3495% CI-4.55 - 9.22p0.505Mixed Models Analysis

Mean Difference (Final Values)-12.8695% CI-21.46 - -4.25p0.003Mixed Models Analysis

Mean Difference (Final Values)1.4795% CI-7.95 - 10.88p0.760Mixed Models Analysis

Secondary/registry result

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

Time frame:Weeks 26, 52 and 78

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebo/Bapineuzumab 0.5 mg/kgWeek 26 (N = 36, 60, 30, 51)n=38 Participants	2.29	1.79
Week 52 (N = 21, 37, 17, 32)n=38 Participants	2.34	2.45
Week 78 (N = 13, 18, 8, 20)n=38 Participants	11.76	4.86
Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kgWeek 26 (N = 36, 60, 30, 51)n=62 Participants	0.21	1.48
Week 52 (N = 21, 37, 17, 32)n=62 Participants	-1.06	1.94
Week 78 (N = 13, 18, 8, 20)n=62 Participants	1.70	4.40
Placebo/Bapineuzumab 1.0 mg/kgWeek 26 (N = 36, 60, 30, 51)n=33 Participants	2.77	1.96
Week 52 (N = 21, 37, 17, 32)n=33 Participants	3.78	2.65
Week 78 (N = 13, 18, 8, 20)n=33 Participants	2.28	6.07
Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kgWeek 26 (N = 36, 60, 30, 51)n=53 Participants	1.73	1.51
Week 52 (N = 21, 37, 17, 32)n=53 Participants	3.99	1.97
Week 78 (N = 13, 18, 8, 20)n=53 Participants	4.76	3.93

Mean Difference (Final Values)-2.0895% CI-6.68 - 2.52p0.373Mixed Models Analysis

Mean Difference (Final Values)-1.0395% CI-5.92 - 3.86p0.677Mixed Models Analysis

Mean Difference (Final Values)-3.4095% CI-9.61 - 2.80p0.280Mixed Models Analysis

Mean Difference (Final Values)0.2195% CI-6.34 - 6.76p0.950Mixed Models Analysis

Mean Difference (Final Values)-10.0695% CI-23.16 - 3.05p0.130Mixed Models Analysis

Mean Difference (Final Values)2.4895% CI-11.97 - 16.94p0.732Mixed Models Analysis

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/Bapineuzumab 0.5 mg/kgn=39 Participants	6	-
Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kgn=66 Participants	10	-
Placebo/Bapineuzumab 1.0 mg/kgn=37 Participants	1	-
Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kgn=56 Participants	11	-
Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kgn=4 Participants	0	-

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.