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| ID | Type | Description | Link |
|---|---|---|---|
| B343-1057, B343-1058 | Other Identifier | Pfizer |
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The purpose of this study is determine the safety, tolerability, and efficacy of 3 doses of lecozotan SR in patients with mild to moderate Alzheimer's Disease over 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
| |
| D | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lecozotan SR | Drug | evaluation of long term therapy with 3 doses of lecozotan sr ( 2, 5, and 10 mg)administered to patients with AD who have completed week 12 evaluations in the short-term study. Patient duration is 42 weeks. Arms include lecozotan sr 2 mg, 5mg, and 10 mg as well as donepezil. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoints will be the change from baseline in ADAS-Cog total score and ADCS-CGIC total score. | weeks 12, 14, 26 and 40. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary efficacy outcome variables include additional cognitive, functional,and behavioral measures. | weeks 12, 14, 26 and 40. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85013 | United States | |||
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|
| Donepezil | Drug | 10 mg donepezil QD dosed up to 40 weeks |
|
| Tucson |
| Arizona |
| 85741 |
| United States |
| Costa Mesa | California | 92626 | United States |
| Fresno | California | 93720 | United States |
| La Jolla | California | 92037 | United States |
| Orange | California | 92868 | United States |
| Boca Raton | Florida | 33486 | United States |
| Delray Beach | Florida | 33445 | United States |
| Fort Lauderdale | Florida | 33321 | United States |
| Fort Myers | Florida | 33916 | United States |
| Hallandale | Florida | 33009 | United States |
| Hialeah | Florida | 33016 | United States |
| Jacksonville | Florida | 32216 | United States |
| Miami | Florida | 33173 | United States |
| Miami | Florida | 33176 | United States |
| Miami Beach | Florida | 33154 | United States |
| Orlando | Florida | 32806 | United States |
| Sarasota | Florida | 34239 | United States |
| Tampa | Florida | 33617 | United States |
| West Palm Beach | Florida | 33407 | United States |
| St Louis | Missouri | 63104 | United States |
| Long Branch | New Jersey | 07740 | United States |
| Manchester Twp. | New Jersey | 08759 | United States |
| Albany | New York | 12208 | United States |
| Cedarhurst | New York | 11516 | United States |
| Lawrence | New York | 11559 | United States |
| Staten Island | New York | 10312 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Columbus | Ohio | 43210 | United States |
| Tulsa | Oklahoma | 74104 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| East Providence | Rhode Island | 02914 | United States |
| Memphis | Tennessee | 38119 | United States |
| Houston | Texas | 77030 | United States |
| Bennington | Vermont | 05201 | United States |
| Av. Belgrano | 2945 | Argentina |
| Calle Adolfo Alsina | 2184 | Argentina |
| Cervino | 3356 | Argentina |
| Gascon | 450 | Argentina |
| Larrea | 1035 | Argentina |
| Nueva York | 3952 | Argentina |
| Pilar | Argentina |
| Puerto Galván | 4102 | Argentina |
| Hornsby | New South Wales | 2077 | Australia |
| Heidelberg Heights | Victoria | 3081 | Australia |
| Edmonton | Alberta | T5G 0B7 | Canada |
| Medicine Hat | Alberta | T1A 4C2 | Canada |
| Moncton | New Brunswick | E1C 4B7 | Canada |
| Ottawa | Ontario | K1N 5C8 | Canada |
| Montreal | Quebec | Canada |
| Regina | Saskatchewan | S4T 1A5 | Canada |
| Westdene | Bloemfontein | 9301 | South Africa |
| Observatory | Cape Town | 7925 | South Africa |
| Panorama | Cape Town | 7500 | South Africa |
| Florida | Johannesburg | 1709 | South Africa |
| Bellville | Western Cape | 7530 | South Africa |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| 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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| ID | Term |
|---|---|
| C500836 | lecozotan |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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