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This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once daily for 14 days in subjects with mild Alzheimer's Disease who are using a stable, well-tolerated 10 mg dose of Aricept (donepezil) but continue to experience worsening AD symptoms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRX-03140 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of PRX-03140 during 2 weeks of treatment. | ||
| Electroencephalogram (EEG) changes through 14 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cognition after 2 weeks of treatment. | ||
| Blood concentrations of PRX-03140 and Aricept during 14 days of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Clinical Trials Medical Group, Inc | Paramount | California | 90723 | United States | ||
| Southwest CLinical Research |
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| Rancho Mirage |
| California |
| 94109 |
| United States |
| Pacific Research Network, Inc | San Diego | California | 92103 | United States |
| San Francisco Clinical Research Center | San Francisco | California | 94109 | United States |
| Torrance Clinical Research | Torrance | California | 90505 | United States |
| Research Center for Clinical Studies | Darien | Connecticut | 06820 | United States |
| Miami Jewish Home and Hospital for the Aged | Miami | Florida | 33137 | United States |
| Berma Research | Plantation | Florida | 33317 | United States |
| Comprehensive NeuroScience, Inc | St. Petersburg | Florida | 33702 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30308 | United States |
| J. Gary Booker, MD | Shreveport | Louisiana | 71104 | United States |
| Neuroscience Research of the Berkshires | Pittsfield | Massachusetts | 01201 | United States |
| Neurology Specialists | Dayton | Ohio | 45408 | United States |
| Saint Johns Office Building | Tulsa | Oklahoma | 74104 | United States |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | United States |
| Alliance for Neuro Research, LLC | Greenville | South Carolina | 29615 | United States |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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