Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease

September 22, 2009 updated by: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study will enroll approximately 375 patients with mild to moderate Alzheimer's disease at investigational sites in the United States and Europe. Patients will receive either AN-1792 or placebo, and they will be evaluated using standard clinical assessments of cognition and memory as well as experimental surrogate markers of Alzheimer's disease pathology. The goal of the study is to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the A-beta peptide in patients with Alzheimer's disease.

Study Type

Interventional

Enrollment

375

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Pivotal Research Centers
      • Phoenix, Arizona, United States, 85013
        • 21st Century Neurology
    • California
      • Beverly Hills, California, United States, 90211
        • California Clinical Trials
      • La Jolla, California, United States, 92093
        • UCSD Medical Center
      • Northridge, California, United States, 91324-4625
        • Pharmacology Research Institute
    • Florida
      • Bay Harbor Islands, Florida, United States, 33154
        • Baumel-Eisner Neuromedical Institute
      • Boca Raton, Florida, United States, 33486
        • Baumel-Eisner Neuromedical Institute
      • Ft. Lauderdale, Florida, United States, 33321
        • Baumel-Eisner Neuromedical Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Clinical Pharmaceutical Trials, Inc.
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Mild to moderate Alzheimer's disease. Ability to cooperate with MRI scanning and neuropsychological testing. Live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion

September 1, 2003

Study Registration Dates

First Submitted

August 2, 2001

First Submitted That Met QC Criteria

August 3, 2001

First Posted (Estimate)

August 6, 2001

Study Record Updates

Last Update Posted (Estimate)

September 24, 2009

Last Update Submitted That Met QC Criteria

September 22, 2009

Last Verified

November 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-1792-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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