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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
375
Pivotal Research Centers
Peoria, Arizona, United States
21st Century Neurology
Phoenix, Arizona, United States
California Clinical Trials
Beverly Hills, California, United States
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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
...and 1 more locations