CompletedPhase 2Results posted

Study Evaluating Bapineuzumab In Alzheimer Disease Subjects

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Safety, Tolerability, Reactogenicity, And Pharmacokinetic Study Of Bapineuzumab (AAB 001) Administered Subcutaneously In Subjects With Mild To Moderate AD

Lead sponsor

Pfizer

Asset

Bapineuzumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 16-26

Primary endpoint

•Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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 ID3133L1-2203

SecondaryB2521008

NCT IDNCT00663026

Timeline

Milestones

Study first posted2008-04-21estimated

Study start2008-11 (month precision)

Primary completion2010-10actual (month precision)

Study completion2010-10actual (month precision)

Last update posted2013-11-15estimated

Results first posted2013-11-15estimated

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 according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria

•Mini-Mental State Examination (MMSE) score 16-26

Exclusion criteria

•Magnetic Resonance Imaging (MRI) showing other brain abnormalities

•Other diagnosed neurological or psychiatric disorders

Endpoints (14)

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.

Safety / tolerability / PK

14 endpoints

Primary/protocol endpoint

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

Time frame:Baseline up to 30 days after Week 25 dose

event count, event

Primary/registry result

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

Time frame:Baseline up to 30 days after Week 25 dose

event count, event

Posted result

Group	Value (number), participants	Reported bounds
PlaceboAEsn=19 Participants	16	-
SAEsn=19 Participants	1	-
Bapineuzumab 5 mgAEsn=29 Participants	22	-
SAEsn=29 Participants	2	-
Bapineuzumab 10 mgAEsn=31 Participants	28	-
SAEsn=31 Participants	3	-

Secondary/protocol endpoint

Maximum Observed Serum Concentration (Cmax)

Time frame:Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

concentration, descriptive

Secondary/protocol endpoint

Average Serum Concentration at Steady State (Cavg,ss)

Time frame:Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

concentration, descriptive

Secondary/protocol endpoint

Serum Decay Half-Life (t1/2)

Time frame:Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Observed Serum Concentration (Tmax)

Time frame:Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

time to event, event

Secondary/protocol endpoint

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

Time frame:Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

concentration, descriptive

Secondary/protocol endpoint

Apparent Systemic Clearance (CL/F)

Time frame:Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

concentration, descriptive

Secondary/registry result

Maximum Observed Serum Concentration (Cmax)

Time frame:Predose, 4 hours [hrs] postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

concentration, descriptive

Posted result

Group	Value (mean), nanogram per milliliter (ng/mL)	Standard deviation
Bapineuzumab 5 mgn=29 Participants	4219.97	945.23
Bapineuzumab 10 mgn=31 Participants	8012.88	2793.53

Secondary/registry result

Average Serum Concentration at Steady State (Cavg,ss)

Time frame:Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
Bapineuzumab 5 mgn=25 Participants	3123.071	1074.116
Bapineuzumab 10 mgn=29 Participants	6912.301	2149.143

Secondary/registry result

Serum Decay Half-Life (t1/2)

Time frame:Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

concentration, descriptive

Secondary/registry result

Time to Reach Maximum Observed Serum Concentration (Tmax)

Time frame:Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

time to event, event

Posted result

Group	Value (median), hours	Reported bounds
Bapineuzumab 5 mgn=29 Participants	3696.00	-1680.00 - 4368.00
Bapineuzumab 10 mgn=31 Participants	4200.00	-72.00 - 4368.00

Secondary/registry result

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

Time frame:Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

concentration, descriptive

Posted result

Group	Value (mean), ng*hr/mL	Standard deviation
Bapineuzumab 5 mgn=25 Participants	524675.88	180451.56
Bapineuzumab 10 mgn=31 Participants	1161266.63	361056.04

Secondary/registry result

Apparent Systemic Clearance (CL/F)

Time frame:Predose, 4 hrs postdose, 72 hrs postdose on Day 3 of Week 0 and 25; Predose on Day 7 (Week 1), Week 10, 14, 16, 18, 22, 26, 30; Predose and 4 hrs postdose on Week 12

concentration, descriptive

Posted result

Group	Value (mean), milliliter/hour/kilogram (mL/hr/kg)	Standard deviation
Bapineuzumab 5 mgn=25 Participants	0.16	0.05
Bapineuzumab 10 mgn=29 Participants	0.132	0.069

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.