Phase 1 N=32 Randomized Double-blind Treatment

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

Alzheimer Disease

Bottom Line

View on ClinicalTrials.gov: NCT00397891 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 5; 3; 6; 3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: bapineuzumab (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: Feb 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	5; 3; 6; 3; 7; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in Physical Examinations	0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Vital Signs of Potential Clinical Importance	2; 0; 2; 1; 1	—
PRIMARY Number of Participants With Electrocardiogram (ECG) Results of Potential Clinical Importance	0; 0; 0; 0; 1	—
PRIMARY Number of Participants With Laboratory Test Results of Potential Clinical Importance	6; 4; 3; 5; 5	—
PRIMARY Number of Participants With Clinically Significant Changes in Neurological Examinations	0; 0; 0; 0; 0	—
PRIMARY Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 6	16.8; 21.0; 21.0; 20.2; 20.6; -0.2	—
PRIMARY Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 16	0.2; -0.7; 0.7; -0.3; -1.4	—
PRIMARY Change From Baseline in Mini-Mental State Examination (MMSE) Score at Week 52	-2.4; -3.8; -0.7; -1.2; -2.9	—
SECONDARY Maximum Observed Serum Concentration (Cmax) of Bapineuzumab	3.32; 11.1; 21.0; 61.0	—
SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) of Bapineuzumab	1.51; 1.54; 1.53; 1.71	—
SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Bapineuzumab	1260; 4264; 7818; 15313	—
SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Bapineuzumab	1279; 4323; 7884; 15405	—
SECONDARY Systemic Clearance (CL) of Bapineuzumab	6.88; 7.49; 7.23; 8.84	—
SECONDARY Volume of Distribution at Steady State (Vss) of Bapineuzumab	5574; 5947; 5827; 6879	—
SECONDARY Mean Residence Time of Bapineuzumab	34.5; 33.3; 33.4; 32.4	—
SECONDARY Serum Decay Half-Life (t1/2) of Bapineuzumab	28.1; 26.7; 26.2; 15.0	—
SECONDARY Serum Bapineuzumab Concentrations	NA; NA; NA; NA; 1602; 5211	—
SECONDARY Number of Participants With Positive Serum Anti-Bapineuzumab Antibody	0; 0; 0; 0; 0	—
SECONDARY Plasma Amyloid-beta (x-40) Concentrations	309; 298; 276; 339; 281; 1009	—

Summary

Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational AAB-001 Vaccine in Japanese patients with Alzheimer's disease.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00397891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.