CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
ACC-001 3 μg/ QS-21 50 μg +2 morebiological
Likely dose
ACC-001 3 μg/ QS-21 50 μgfrom 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/NCT01227564
NCT01227564Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.

Pfizer·interventional·Posted Oct 25, 2010·Updated Feb 25, 2016

In Brief

A Phase 2 clinical trial evaluating ACC-001 3 μg/ QS-21 50 μg, ACC-001 10 μg/ QS-21 50 μg, and 1 other intervention for Alzheimer's Disease. Completed, enrolled 63 participants across 40 sites.

Detailed Summary

This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
CountriesUnited States
CollaboratorsJANSSEN Alzheimer Immunotherapy Research & Development, LLC

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2010
Enrollment StartFeb 1, 2011
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.7 years ago

Interventions

ACC-001 3 μg/ QS-21 50 μgbiological

ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18

ACC-001 10 μg/ QS-21 50 μgbiological

ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18

Placebo- Phosphate buffered saline (PBS)other

Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18