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
• 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
• 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

• Alzheimer Disease
• Alzheimer's Disease

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,