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Sponsored by: |
Epix Pharmaceuticals, Inc. |
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Information provided by: | Epix Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00693004 |
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 |
Ages Eligible for Study: | 50 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Julia Kazakin, MD | 781-761-7646 | jkazakin@epixpharma.com |
Responsible Party: | EPIX Pharmaceuticals, Inc. ( Elkan R. Gamzu, PhD ) |
Study ID Numbers: | Protocol 03140-203 |
Study First Received: | May 30, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00693004 |
Health Authority: | United States: Food and Drug Administration |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |