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

Phase 2
Terminated
Conditions
Alzheimer's Disease
Registration Number
NCT00021723
Lead Sponsor
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
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.

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
375
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (9)

Pivotal Research Centers

🇺🇸

Peoria, Arizona, United States

21st Century Neurology

🇺🇸

Phoenix, Arizona, United States

Pharmacology Research Institute

🇺🇸

Northridge, California, United States

UCSD Medical Center

🇺🇸

La Jolla, California, United States

Baumel-Eisner Neuromedical Institute

🇺🇸

Ft. Lauderdale, Florida, United States

California Clinical Trials

🇺🇸

Beverly Hills, California, United States

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Clinical Pharmaceutical Trials, Inc.

🇺🇸

Tulsa, Oklahoma, United States

Baylor College of Medicine

🇺🇸

Houston, Texas, United States

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