CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
ACC-001 +4 morebiological
Likely dose
ACC-001 30 microgramsfrom 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/NCT00752232
NCT00752232Phase 2Completed
CompareCT.gov

A Phaseiia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.

Pfizer·interventional·Posted Sep 15, 2008·Updated Jan 1, 2016

In Brief

A Phase 2 clinical trial evaluating ACC-001, QS-21, and 1 other intervention for Alzheimer Disease. Completed, enrolled 40 participants across 10 sites.

Detailed Summary

The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 15, 2008
Enrollment StartDec 1, 2008
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.8 years ago

Interventions

ACC-001biological

IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12

QS-21other

IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12

ACC-001biological

IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12

QS-21other

IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12

PBSother

IM injection, Day 1, month 3, 6, 9, 12