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

NCT01238991 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2014-12-22

Study results available
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Summary

The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.

Conditions

Interventions

BIOLOGICAL

ACC-001

IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18

BIOLOGICAL

ACC-001

IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18

BIOLOGICAL

ACC-001

IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18

Sponsors & Collaborators

  • JANSSEN Alzheimer Immunotherapy Research & Development, LLC

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
52 Years
Max Age
87 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
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 NCT01238991 on ClinicalTrials.gov