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

NCT00959192 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-01-01

Study results available
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Summary

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

Conditions

Interventions

BIOLOGICAL

ACC-001

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

OTHER

QS-21

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

OTHER

QS-21

IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12

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
2009-08-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT00959192 on ClinicalTrials.gov