Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease
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Purpose
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 |
| Estimated Enrollment: | 375 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | September 2003 |
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.
Eligibility| 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| 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 | |
More Information
No publications provided
| 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:
|
Alzheimer's AN-1792 AIP-001 |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013