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A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease

NCT00960531 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2016-04-01

Study results available
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Summary

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.

Conditions

  • Alzheimer Disease

Interventions

BIOLOGICAL

ACC-001+ QS21 (3mcg)

ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

BIOLOGICAL

ACC-001 (10 mcg) + QS-21

ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

BIOLOGICAL

ACC-001+QS-21 (30mcg)

ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

Sponsors & Collaborators

  • JANSSEN Alzheimer Immunotherapy Research & Development, LLC

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00960531 on ClinicalTrials.gov