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Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

NCT00498602 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2016-01-01

Study results available
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Summary

To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.

Conditions

  • Alzheimer Disease

Interventions

BIOLOGICAL

ACC-001 + QS-21

IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52

BIOLOGICAL

QS-21

IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52

OTHER

Diluent: Phosphate Buffered Saline

IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52

BIOLOGICAL

ACC-001

IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52

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
2007-11-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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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 NCT00498602 on ClinicalTrials.gov