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

This study has been terminated.
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
First received: August 2, 2001
Last updated: September 22, 2009
Last verified: November 2001
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.

Condition Intervention Phase
Alzheimer's Disease
Biological: AN-1792 also known as AIP-001
Phase 2

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

Resource links provided by NLM:

Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Estimated Enrollment: 375
Study Start Date: September 2001
Estimated Study Completion Date: September 2003
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.

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00021723

United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
21st Century Neurology
Phoenix, Arizona, United States, 85013
United States, California
California Clinical Trials
Beverly Hills, California, United States, 90211
UCSD Medical Center
La Jolla, California, United States, 92093
Pharmacology Research Institute
Northridge, California, United States, 91324-4625
United States, Florida
Baumel-Eisner Neuromedical Institute
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
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Oklahoma
Clinical Pharmaceutical Trials, Inc.
Tulsa, Oklahoma, United States, 74104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: VP Clinical Development, JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00021723     History of Changes
Other Study ID Numbers: AN-1792-201 
Study First Received: August 2, 2001
Last Updated: September 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 26, 2016