CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 160 enrolled
Drug / intervention
ACC-001(3µg) + QS21 +2 morebiological
Likely dose
ACC-001(3µg) + QS21from 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/NCT00955409
NCT00955409Phase 2Completed
CompareCT.gov

A PHASE IIA, MULTICENTER, RANDOMIZED, THIRD-PARTY UNBLINDED, LONG -TERM EXTENSION STUDY TO DETERMINE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF ACC-001 WITH QS-21 ADJUVANT IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE

Pfizer·interventional·Posted Aug 10, 2009·Updated Mar 25, 2021

In Brief

A Phase 2 clinical trial evaluating ACC-001(3µg) + QS21, ACC-001(10µg) + QS21, and 1 other intervention for Alzheimer Disease. Completed, enrolled 160 participants across 17 sites in 3 countries.

Detailed Summary

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesFrance, Germany, Spain
CollaboratorsJANSSEN Alzheimer Immunotherapy Research & Development, LLC

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2009
Enrollment StartNov 5, 2009
Primary CompletionDec 17, 2013
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 16.9 years ago

Interventions

ACC-001(3µg) + QS21biological

Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

ACC-001(10µg) + QS21biological

Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

ACC-001(30µg) + QS21biological

Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18