Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

NCT00479557 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2016-01-01

Study results available
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Summary

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

Conditions

  • Alzheimer Disease

Interventions

BIOLOGICAL

ACC-001 + QS-21

Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12

BIOLOGICAL

ACC-001

Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12

BIOLOGICAL

QS-21

QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12

DRUG

Placebo: Phosphate buffered saline

Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12

Sponsors & Collaborators

  • Janssen Alzheimer Immunotherapy (JAI) Research and Development, LLC

    collaborator UNKNOWN
  • 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
2007-05-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • France
  • Germany
  • Spain

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 NCT00479557 on ClinicalTrials.gov