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NCT00021723 Clinical Trial

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

Alzheimer's Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00021723
Other study ID # AN-1792-201
Secondary ID
Status Terminated
Phase Phase 2
First received August 2, 2001
Last updated September 22, 2009
Start date September 2001
Est. completion date September 2003

Study information
Verified date November 2001
Source JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 375
Est. completion date September 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 85 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• AN-1792 also known as AIP-001

Locations
Country Name City State
United States Baumel-Eisner Neuromedical Institute Bay Harbor Islands Florida
United States California Clinical Trials Beverly Hills California
United States Baumel-Eisner Neuromedical Institute Boca Raton Florida
United States Baumel-Eisner Neuromedical Institute Ft. Lauderdale Florida
United States Baylor College of Medicine Houston Texas
United States UCSD Medical Center La Jolla California
United States Pharmacology Research Institute Northridge California
United States Pivotal Research Centers Peoria Arizona
United States 21st Century Neurology Phoenix Arizona
United States Mayo Clinic Rochester Minnesota
United States Clinical Pharmaceutical Trials, Inc. Tulsa Oklahoma

Sponsors (2)
Lead Sponsor Collaborator
JANSSEN Alzheimer Immunotherapy Research & Development, LLC Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

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