CompletedPhase 1Results posted

Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease

A Multicenter, Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, and Pharmakokinetic Study of Single Ascending Doses of AAB-001 in Japanese Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Asset

Bapineuzumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 14-26

Primary endpoints

•Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)•Clinically Significant Changes in Physical Examinations•Vital Signs of Potential Clinical Importance

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 ID3133K1-102

NCT IDNCT00397891

Timeline

Milestones

Study start2006-10 (month precision)

Study first posted2006-11-10estimated

Primary completion2010-02actual (month precision)

Study completion2010-02actual (month precision)

Last update posted2014-09-04estimated

Results first posted2014-09-04estimated

Assets

Drug assets

Bapineuzumab

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

•Diagnosis of AD

•Age 50-85

•MMSE 14-26

•Other Inclusion Criteria Apply

Exclusion criteria

•Significant Neurological Disease

•Major Psychiatric Disorder

•Clinically Significant Systemic Illness

•Other Exclusion Criteria Apply

Endpoints (40)

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

Safety / tolerability / PK

Other (unclassified)

Global cognition

Amyloid biomarkers

Global cognition

6 endpoints

Primary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6

Time frame:Baseline, Week 6

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16

Time frame:Baseline, Week 16

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52

Time frame:Baseline, Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6

Time frame:Baseline, Week 6

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Bapineuzumab 0.15 mg/kgBaselinen=6 Participants	16.8	2.9
Change at Week 6n=6 Participants	-0.2	2.1
Bapineuzumab 0.5 mg/kgBaselinen=6 Participants	21.0	3.6
Change at Week 6n=6 Participants	0.0	2.3
Bapineuzumab 1.0 mg/kgBaselinen=6 Participants	21.0	4.6
Change at Week 6n=6 Participants	-0.3	3.0
Bapineuzumab 2.0 mg/kgBaselinen=6 Participants	20.2	2.8
Change at Week 6n=6 Participants	-0.2	3.8
PlaceboBaselinen=8 Participants	20.6	3.0
Change at Week 6n=8 Participants	-1.9	3.1

Primary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16

Time frame:Baseline, Week 16

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Bapineuzumab 0.15 mg/kgn=6 Participants	0.2	2.9
Bapineuzumab 0.5 mg/kgn=6 Participants	-0.7	4.1
Bapineuzumab 1.0 mg/kgn=6 Participants	0.7	2.4
Bapineuzumab 2.0 mg/kgn=6 Participants	-0.3	2.4
Placebon=7 Participants	-1.4	2.6

Primary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52

Time frame:Baseline, Week 52

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Bapineuzumab 0.15 mg/kgn=5 Participants	-2.4	1.9
Bapineuzumab 0.5 mg/kgn=6 Participants	-3.8	6.4
Bapineuzumab 1.0 mg/kgn=6 Participants	-0.7	2.7
Bapineuzumab 2.0 mg/kgn=6 Participants	-1.2	5.6
Placebon=7 Participants	-2.9	1.3

Amyloid biomarkers

2 endpoints

Secondary/protocol endpoint

Plasma Amyloid-beta (x-40) Concentrations

Time frame:0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion

concentration, descriptive

Secondary/registry result

Plasma Amyloid-beta (x-40) Concentrations

Time frame:0 (pre-infusion), 1, 6, 24, 336, 1008, 2184, 2688, 4368, 8736 hours post start of infusion

concentration, descriptive

Posted result

Group	Value (mean), picogram per milliliter (pg/mL)	Standard deviation
Bapineuzumab 0.15 mg/kg0 Hour (n=6,6,6,6,8)n=6 Participants	309	116
1 Hour (n=6,5,5,6,8)n=6 Participants	1009	369
6 Hour (n=6,6,6,6,8)n=6 Participants	1697	871
24 Hour (n=6,6,6,6,8)n=6 Participants	1474	844
336 Hour (n=6,6,6,6,8)n=6 Participants	784	320
1008 Hour (n=6,6,6,6,8)n=6 Participants	543	219
2184 Hour (n=6,6,6,6,7)n=6 Participants	331	119
2688 Hour (n=6,6,6,6,7)n=6 Participants	341	108
4368 Hour (n=5,6,6,6,7)n=6 Participants	302	86
8736 Hour (n=5,6,6,6,7)n=6 Participants	298	107
Bapineuzumab 0.5 mg/kg0 Hour (n=6,6,6,6,8)n=6 Participants	298	91
1 Hour (n=6,5,5,6,8)n=6 Participants	1050	142
6 Hour (n=6,6,6,6,8)n=6 Participants	2664	509
24 Hour (n=6,6,6,6,8)n=6 Participants	3581	660
336 Hour (n=6,6,6,6,8)n=6 Participants	1675	396
1008 Hour (n=6,6,6,6,8)n=6 Participants	985	328
2184 Hour (n=6,6,6,6,7)n=6 Participants	488	142
2688 Hour (n=6,6,6,6,7)n=6 Participants	471	114
4368 Hour (n=5,6,6,6,7)n=6 Participants	310	74
8736 Hour (n=5,6,6,6,7)n=6 Participants	308	29
Bapineuzumab 1.0 mg/kg0 Hour (n=6,6,6,6,8)n=6 Participants	276	43
1 Hour (n=6,5,5,6,8)n=6 Participants	1593	88
6 Hour (n=6,6,6,6,8)n=6 Participants	3755	356
24 Hour (n=6,6,6,6,8)n=6 Participants	5333	426
336 Hour (n=6,6,6,6,8)n=6 Participants	3345	485
1008 Hour (n=6,6,6,6,8)n=6 Participants	1566	281
2184 Hour (n=6,6,6,6,7)n=6 Participants	668	157
2688 Hour (n=6,6,6,6,7)n=6 Participants	528	128
4368 Hour (n=5,6,6,6,7)n=6 Participants	351	33
8736 Hour (n=5,6,6,6,7)n=6 Participants	342	41
Bapineuzumab 2.0 mg/kg0 Hour (n=6,6,6,6,8)n=6 Participants	339	20
1 Hour (n=6,5,5,6,8)n=6 Participants	1708	247
6 Hour (n=6,6,6,6,8)n=6 Participants	3905	656
24 Hour (n=6,6,6,6,8)n=6 Participants	7405	1630
336 Hour (n=6,6,6,6,8)n=6 Participants	4325	670
1008 Hour (n=6,6,6,6,8)n=6 Participants	2664	601
2184 Hour (n=6,6,6,6,7)n=6 Participants	1149	432
2688 Hour (n=6,6,6,6,7)n=6 Participants	803	268
4368 Hour (n=5,6,6,6,7)n=6 Participants	425	68
8736 Hour (n=5,6,6,6,7)n=6 Participants	299	22
Placebo0 Hour (n=6,6,6,6,8)n=8 Participants	281	38
1 Hour (n=6,5,5,6,8)n=8 Participants	292	48
6 Hour (n=6,6,6,6,8)n=8 Participants	293	40
24 Hour (n=6,6,6,6,8)n=8 Participants	302	71
336 Hour (n=6,6,6,6,8)n=8 Participants	279	54
1008 Hour (n=6,6,6,6,8)n=8 Participants	287	41
2184 Hour (n=6,6,6,6,7)n=8 Participants	278	59
2688 Hour (n=6,6,6,6,7)n=8 Participants	307	81
4368 Hour (n=5,6,6,6,7)n=8 Participants	291	71
8736 Hour (n=5,6,6,6,7)n=8 Participants	283	42

Safety / tolerability / PK

18 endpoints

Primary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame:Baseline up to Week 52

event count, event

Primary/protocol endpoint

Number of Participants With Vital Signs of Potential Clinical Importance

Time frame:Baseline up to Week 52

event count, event

Primary/protocol endpoint

Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance

Time frame:Screening up to Week 16

event count, event

Primary/registry result

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame:Baseline up to Week 52

event count, event

Posted result

Group	Value (number), participants	Reported bounds
Bapineuzumab 0.15 mg/kgAEsn=6 Participants	5	-
SAEsn=6 Participants	0	-
Bapineuzumab 0.5 mg/kgAEsn=6 Participants	3	-
SAEsn=6 Participants	0	-
Bapineuzumab 1.0 mg/kgAEsn=6 Participants	6	-
SAEsn=6 Participants	0	-
Bapineuzumab 2.0 mg/kgAEsn=6 Participants	3	-
SAEsn=6 Participants	0	-
PlaceboAEsn=8 Participants	7	-
SAEsn=8 Participants	0	-

Primary/registry result

Number of Participants With Vital Signs of Potential Clinical Importance

Time frame:Baseline up to Week 52

event count, event

Posted result

Group	Value (number), participants	Reported bounds
Bapineuzumab 0.15 mg/kgn=6 Participants	2	-
Bapineuzumab 0.5 mg/kgn=6 Participants	0	-
Bapineuzumab 1.0 mg/kgn=6 Participants	2	-
Bapineuzumab 2.0 mg/kgn=6 Participants	1	-
Placebon=8 Participants	1	-

Primary/registry result

Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance

Time frame:Screening up to Week 16

event count, event

Posted result

Group	Value (number), participants	Reported bounds
Bapineuzumab 0.15 mg/kgn=6 Participants	0	-
Bapineuzumab 0.5 mg/kgn=6 Participants	0	-
Bapineuzumab 1.0 mg/kgn=6 Participants	0	-
Bapineuzumab 2.0 mg/kgn=6 Participants	0	-
Placebon=8 Participants	1	-

Secondary/protocol endpoint

Maximum Observed Serum Concentration (Cmax) of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

time to event, event

Secondary/protocol endpoint

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

concentration, descriptive

Secondary/protocol endpoint

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

concentration, descriptive

Secondary/protocol endpoint

Mean Residence Time of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

time to event, event

Secondary/protocol endpoint

Serum Decay Half-Life (t1/2) of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

concentration, descriptive

Secondary/registry result

Maximum Observed Serum Concentration (Cmax) of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

concentration, descriptive

Posted result

Group	Value (mean), microgram per milliliter (mcg/mL)	Standard deviation
Bapineuzumab 0.15 mg/kgn=6 Participants	3.32	0.857
Bapineuzumab 0.5 mg/kgn=6 Participants	11.1	1.16
Bapineuzumab 1.0 mg/kgn=6 Participants	21.0	0.968
Bapineuzumab 2.0 mg/kgn=6 Participants	61.0	32.8

Secondary/registry result

Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

time to event, event

Posted result

Group	Value (median), hours	Reported bounds
Bapineuzumab 0.15 mg/kgn=6 Participants	1.51	-1.08 - 3.91
Bapineuzumab 0.5 mg/kgn=6 Participants	1.54	-1.00 - 5.86
Bapineuzumab 1.0 mg/kgn=6 Participants	1.53	-1.00 - 2.00
Bapineuzumab 2.0 mg/kgn=6 Participants	1.71	-0.45 - 5.95

Secondary/registry result

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

concentration, descriptive

Posted result

Group	Value (mean), mcg*hour/mL	Standard deviation
Bapineuzumab 0.15 mg/kgn=6 Participants	1260	254
Bapineuzumab 0.5 mg/kgn=6 Participants	4264	462
Bapineuzumab 1.0 mg/kgn=6 Participants	7818	652
Bapineuzumab 2.0 mg/kgn=6 Participants	15313	8478

Secondary/registry result

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

concentration, descriptive

Posted result

Group	Value (mean), mcg*hour/mL	Standard deviation
Bapineuzumab 0.15 mg/kgn=6 Participants	1279	266
Bapineuzumab 0.5 mg/kgn=6 Participants	4323	456
Bapineuzumab 1.0 mg/kgn=6 Participants	7884	640
Bapineuzumab 2.0 mg/kgn=6 Participants	15405	8438

Secondary/registry result

Mean Residence Time of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

time to event, event

Posted result

Group	Value (mean), days	Standard deviation
Bapineuzumab 0.15 mg/kgn=6 Participants	34.5	7.0
Bapineuzumab 0.5 mg/kgn=6 Participants	33.3	4.4
Bapineuzumab 1.0 mg/kgn=6 Participants	33.4	5.2
Bapineuzumab 2.0 mg/kgn=6 Participants	32.4	4.6

Secondary/registry result

Serum Decay Half-Life (t1/2) of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

concentration, descriptive

Posted result

Group	Value (mean), days	Standard deviation
Bapineuzumab 0.15 mg/kgn=6 Participants	28.1	5.9
Bapineuzumab 0.5 mg/kgn=6 Participants	26.7	1.8
Bapineuzumab 1.0 mg/kgn=6 Participants	26.2	3.4
Bapineuzumab 2.0 mg/kgn=6 Participants	15.0	9.9

Other (unclassified)

14 endpoints

Primary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Changes in Physical Examinations

Time frame:Screening up to Week 52

event count, event

Primary/protocol endpoint/low confidence

Number of Participants With Laboratory Test Results of Potential Clinical Importance

Time frame:Week 1 up to Week 52

event count, event

Primary/protocol endpoint/low confidence

Number of Participants With Clinically Significant Changes in Neurological Examinations

Time frame:Screening up to Week 52

event count, event

Primary/registry result/low confidence

Number of Participants With Clinically Significant Changes in Physical Examinations

Time frame:Screening up to Week 52

event count, event

Posted result

Group	Value (number), participants	Reported bounds
Bapineuzumab 0.15 mg/kgn=6 Participants	0	-
Bapineuzumab 0.5 mg/kgn=6 Participants	0	-
Bapineuzumab 1.0 mg/kgn=6 Participants	0	-
Bapineuzumab 2.0 mg/kgn=6 Participants	0	-
Placebon=8 Participants	0	-

Primary/registry result/low confidence

Number of Participants With Laboratory Test Results of Potential Clinical Importance

Time frame:Week 1 up to Week 52

event count, event

Posted result

Group	Value (number), participants	Reported bounds
Bapineuzumab 0.15 mg/kgn=6 Participants	6	-
Bapineuzumab 0.5 mg/kgn=6 Participants	4	-
Bapineuzumab 1.0 mg/kgn=6 Participants	3	-
Bapineuzumab 2.0 mg/kgn=6 Participants	5	-
Placebon=8 Participants	5	-

Primary/registry result/low confidence

Number of Participants With Clinically Significant Changes in Neurological Examinations

Time frame:Screening up to Week 52

event count, event

Posted result

Group	Value (number), participants	Reported bounds
Bapineuzumab 0.15 mg/kgn=6 Participants	0	-
Bapineuzumab 0.5 mg/kgn=6 Participants	0	-
Bapineuzumab 1.0 mg/kgn=6 Participants	0	-
Bapineuzumab 2.0 mg/kgn=6 Participants	0	-
Placebon=8 Participants	0	-

Secondary/protocol endpoint/low confidence

Systemic Clearance (CL) of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

descriptive

Secondary/protocol endpoint/low confidence

Volume of Distribution at Steady State (Vss) of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

concentration, descriptive

Secondary/protocol endpoint/low confidence

Serum Bapineuzumab Concentrations

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6, 24, 48, 168, 336, 672, 1008, 1344, 1848, 2184, 2688, 4368, 8736 hours post start of infusion

concentration, descriptive

Secondary/protocol endpoint/low confidence

Number of Participants With Positive Serum Anti-Bapineuzumab Antibody

Time frame:Baseline (Day 1) up to Week 52

concentration, descriptive

Secondary/registry result/low confidence

Systemic Clearance (CL) of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

descriptive

Posted result

Group	Value (mean), mL/hour	Standard deviation
Bapineuzumab 0.15 mg/kgn=6 Participants	6.88	1.32
Bapineuzumab 0.5 mg/kgn=6 Participants	7.49	1.71
Bapineuzumab 1.0 mg/kgn=6 Participants	7.23	1.49
Bapineuzumab 2.0 mg/kgn=6 Participants	8.84	3.97

Secondary/registry result/low confidence

Volume of Distribution at Steady State (Vss) of Bapineuzumab

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6 hours post start of infusion on Day 1; Day 2, 3; Week 1, 2, 4, 6, 8, 11, 13, 16, 26, 52

concentration, descriptive

Posted result

Group	Value (mean), mL	Standard deviation
Bapineuzumab 0.15 mg/kgn=6 Participants	5574	906.5
Bapineuzumab 0.5 mg/kgn=6 Participants	5947	1406
Bapineuzumab 1.0 mg/kgn=6 Participants	5827	1611
Bapineuzumab 2.0 mg/kgn=6 Participants	6879	3132

Secondary/registry result/low confidence

Serum Bapineuzumab Concentrations

Time frame:0 (pre-infusion), 0.5, 1, 1.5, 2, 4, 6, 24, 48, 168, 336, 672, 1008, 1344, 1848, 2184, 2688, 4368, 8736 hours post start of infusion

concentration, descriptive

Posted result

Group	Value (mean), nanogram per milliliter (ng/mL)	Standard deviation
Bapineuzumab 0.15 mg/kg0 Hour (n=0,0,0,0)n=6 Participants	NA	NA
0.5 Hour (n=6,5,6,6)n=6 Participants	1602	464
1 Hour (n=6,6,6,6)n=6 Participants	2970	624
1.5 Hour (n=6,6,6,6)n=6 Participants	3093	696
2 Hour (n=6,6,6,6)n=6 Participants	2854	726
4 Hour (n=6,6,6,6)n=6 Participants	2917	1079
6 Hour (n=6,6,6,6)n=6 Participants	2678	845
24 Hour (n=6,6,6,6)n=6 Participants	2276	665
48 Hour (n=6,6,6,6)n=6 Participants	1946	379
168 Hour (n=6,6,6,6)n=6 Participants	1279	225
336 Hour (n=6,6,6,6)n=6 Participants	911	271
672 Hour (n=6,6,6,6)n=6 Participants	599	80
1008 Hour (n=6,6,6,6)n=6 Participants	384	127
1344 Hour (n=6,6,6,6)n=6 Participants	267	76
1848 Hour (n=6,6,6,6)n=6 Participants	158	61
2184 Hour (n=6,6,4,6)n=6 Participants	107	49
2688 Hour (n=6,6,6,6)n=6 Participants	69	41
4368 Hour (n=5,5,6,2)n=6 Participants	14	12
8736 Hour (n=0,0,0,0)n=6 Participants	NA	NA
Bapineuzumab 0.5 mg/kg0 Hour (n=0,0,0,0)n=6 Participants	NA	NA
0.5 Hour (n=6,5,6,6)n=6 Participants	5211	1025
1 Hour (n=6,6,6,6)n=6 Participants	10259	1421
1.5 Hour (n=6,6,6,6)n=6 Participants	10861	1398
2 Hour (n=6,6,6,6)n=6 Participants	10362	1473
4 Hour (n=6,6,6,6)n=6 Participants	10044	1564
6 Hour (n=6,6,6,6)n=6 Participants	9753	1209
24 Hour (n=6,6,6,6)n=6 Participants	7774	1249
48 Hour (n=6,6,6,6)n=6 Participants	6423	774
168 Hour (n=6,6,6,6)n=6 Participants	4431	826
336 Hour (n=6,6,6,6)n=6 Participants	3441	344
672 Hour (n=6,6,6,6)n=6 Participants	1940	328
1008 Hour (n=6,6,6,6)n=6 Participants	1396	326
1344 Hour (n=6,6,6,6)n=6 Participants	811	120
1848 Hour (n=6,6,6,6)n=6 Participants	519	126
2184 Hour (n=6,6,4,6)n=6 Participants	375	95
2688 Hour (n=6,6,6,6)n=6 Participants	221	96
4368 Hour (n=5,5,6,2)n=6 Participants	46	20
8736 Hour (n=0,0,0,0)n=6 Participants	NA	NA
Bapineuzumab 1.0 mg/kg0 Hour (n=0,0,0,0)n=6 Participants	NA	NA
0.5 Hour (n=6,5,6,6)n=6 Participants	8158	332
1 Hour (n=6,6,6,6)n=6 Participants	19939	868
1.5 Hour (n=6,6,6,6)n=6 Participants	20423	1559
2 Hour (n=6,6,6,6)n=6 Participants	19200	1333
4 Hour (n=6,6,6,6)n=6 Participants	17588	1762
6 Hour (n=6,6,6,6)n=6 Participants	18935	1194
24 Hour (n=6,6,6,6)n=6 Participants	12983	224
48 Hour (n=6,6,6,6)n=6 Participants	12179	372
168 Hour (n=6,6,6,6)n=6 Participants	8170	369
336 Hour (n=6,6,6,6)n=6 Participants	6374	547
672 Hour (n=6,6,6,6)n=6 Participants	3379	1409
1008 Hour (n=6,6,6,6)n=6 Participants	2295	376
1344 Hour (n=6,6,6,6)n=6 Participants	1389	318
1848 Hour (n=6,6,6,6)n=6 Participants	990	312
2184 Hour (n=6,6,4,6)n=6 Participants	796	126
2688 Hour (n=6,6,6,6)n=6 Participants	468	101
4368 Hour (n=5,5,6,2)n=6 Participants	70	28
8736 Hour (n=0,0,0,0)n=6 Participants	NA	NA
Bapineuzumab 2.0 mg/kg0 Hour (n=0,0,0,0)n=6 Participants	NA	NA
0.5 Hour (n=6,5,6,6)n=6 Participants	29206	26241
1 Hour (n=6,6,6,6)n=6 Participants	48995	41719
1.5 Hour (n=6,6,6,6)n=6 Participants	43798	34612
2 Hour (n=6,6,6,6)n=6 Participants	48008	26387
4 Hour (n=6,6,6,6)n=6 Participants	32399	14264
6 Hour (n=6,6,6,6)n=6 Participants	34349	14934
24 Hour (n=6,6,6,6)n=6 Participants	25567	20599
48 Hour (n=6,6,6,6)n=6 Participants	20575	18648
168 Hour (n=6,6,6,6)n=6 Participants	15925	10963
336 Hour (n=6,6,6,6)n=6 Participants	12325	5331
672 Hour (n=6,6,6,6)n=6 Participants	6720	4830
1008 Hour (n=6,6,6,6)n=6 Participants	5064	2197
1344 Hour (n=6,6,6,6)n=6 Participants	4440	1755
1848 Hour (n=6,6,6,6)n=6 Participants	2172	1289
2184 Hour (n=6,6,4,6)n=6 Participants	1386	950
2688 Hour (n=6,6,6,6)n=6 Participants	595	678
4368 Hour (n=5,5,6,2)n=6 Participants	25	10
8736 Hour (n=0,0,0,0)n=6 Participants	NA	NA

Secondary/registry result/low confidence

Number of Participants With Positive Serum Anti-Bapineuzumab Antibody

Time frame:Baseline (Day 1) up to Week 52

concentration, descriptive

Posted result

Group	Value (number), participants	Reported bounds
Bapineuzumab 0.15 mg/kgn=6 Participants	0	-
Bapineuzumab 0.5 mg/kgn=6 Participants	0	-
Bapineuzumab 1.0 mg/kgn=6 Participants	0	-
Bapineuzumab 2.0 mg/kgn=6 Participants	0	-
Placebon=8 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

Arai H, Umemura K, Ichimiya Y, Iseki E, Eto K, Miyakawa K, Kirino E, Shibata N, Baba H, Tsuchiwata S. Safety and pharmacokinetics of bapineuzumab in a single ascending-dose study in Japanese patients with mild to moderate Alzheimer's disease. Geriatr Gerontol Int. 2016 May;16(5):644-50. doi: 10.1111/ggi.12516. Epub 2015 Jun 4.
PMID26044070via 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.