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| Sponsor: | Epix Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Epix Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00693004 |
Purpose
A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment period and an optional 3-month extension period.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: PRX-03140 Drug: Donepezil Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of PRX-03140 as Monotherapy in Subjects With Alzheimer's Disease |
| Estimated Enrollment: | 236 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo: Placebo Comparator | Drug: Placebo |
| PRX-03140: Experimental | Drug: PRX-03140 |
| donepezil: Active Comparator | Drug: Donepezil |
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 33 Study Locations
More Information
| Responsible Party: | EPIX Pharmaceuticals, Inc. ( Elkan R. Gamzu, PhD ) |
| Study ID Numbers: | Protocol 03140-203 |
| Study First Received: | May 30, 2008 |
| Last Updated: | July 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00693004 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Nootropic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Cholinergic Agents Brain Diseases |
Neurodegenerative Diseases Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Donepezil Dementia Tauopathies Central Nervous System Agents |