CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 80 enrolled
Drug / intervention
bapineuzumab +2 moredrug
Likely dose
bapineuzumab 0.15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00397891
NCT00397891Phase 1Completed
CompareCT.gov

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

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Nov 10, 2006·Updated Sep 4, 2014

In Brief

A Phase 1 clinical trial evaluating bapineuzumab for Alzheimer Disease. Completed, enrolled 80 participants across 4 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 10, 2006
Enrollment StartOct 1, 2006
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.6 years ago

Interventions

bapineuzumabdrug

The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.

bapineuzumabdrug

The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.

bapineuzumabdrug

The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.