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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.
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.
Age
50 - 85 years
Sex
ALL
Healthy Volunteers
No
Pivotal Research Centers
Peoria, Arizona, United States
21st Century Neurology
Phoenix, Arizona, United States
California Clinical Trials
Beverly Hills, California, United States
UCSD Medical Center
La Jolla, California, United States
Pharmacology Research Institute
Northridge, California, United States
Baumel-Eisner Neuromedical Institute
Bay Harbor Islands, Florida, United States
Baumel-Eisner Neuromedical Institute
Boca Raton, Florida, United States
Baumel-Eisner Neuromedical Institute
Fort Lauderdale, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Clinical Pharmaceutical Trials, Inc.
Tulsa, Oklahoma, United States
Start Date
September 1, 2001
Completion Date
September 1, 2003
Last Updated
September 24, 2009
375
Estimated participants
AN-1792 also known as AIP-001
BIOLOGICAL
Lead Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07033494