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

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ClinicalTrials.gov Identifier: NCT00021723
Recruitment Status : Terminated
First Posted : August 6, 2001
Last Update Posted : September 24, 2009
Information provided by:

Study Description
Brief 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.

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

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 2001
Estimated Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: August 6, 2001    Key Record Dates
Last Update Posted: September 24, 2009
Last Verified: November 2001

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

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