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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002654-75 | EudraCT Number |
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Study has been suspended due to clinical hold.
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This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive EVP-6124 for an additional 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVP-6124, low dose | Experimental | low dose, Tablet, Once Daily, Day 1 through Day 182 |
|
| EVP-6124, high dose | Experimental | high dose, Tablet, Once Daily, Day 1 through Day 182 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVP-6124 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of 2 fixed doses of EVP-6124 for up to 52 weeks in subjects with Alzheimer's disease who complete study EVP-6124-024 or EVP-6124-025 | Criteria for evaluation include: adverse events, clinical laboratory tests, vital signs, body weight, 12-lead ECG, physical examination, concomitant medications, C-SSRS, and GDS. | Baseline to Day 182 or Early Termination |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in cognition using the Mini-Mental State Examination (MMSE) | Baseline to Day 182 or Early Termination | |
| Change from Baseline in psychiatric and behavioral symptoms using the Neuropsychiatric Inventory (NPI) | Baseline to Day 182 or Early Termination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
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| Change from Baseline in quality of life using the EuroQol-5D (EQ-5D) | Baseline to Day 182 or Early Termination |
| Pharmacoeconomic outcomes using the Resource Utilization in Dementia (RUD-Lite 3.3) | Baseline to Day 182 or Early Termination |
| Caregiver perceived burden using the Zarit Burden Interview (ZBI) | Baseline to Day 182 or Early Termination |
| Tucson |
| Arizona |
| United States |
| Little Rock | Arkansas | United States |
| Costa Mesa | California | United States |
| Culver City | California | United States |
| Encino | California | United States |
| Glendale | California | United States |
| Long Beach | California | United States |
| Los Alamitos | California | United States |
| Orange | California | United States |
| Redding | California | United States |
| San Diego | California | United States |
| New Haven | Connecticut | United States |
| Norwich | Connecticut | United States |
| Atlantis | Florida | United States |
| Brooksville | Florida | United States |
| Delray Beach | Florida | United States |
| Fort Myers | Florida | United States |
| Hallandale | Florida | United States |
| Hialeah | Florida | United States |
| Jacksonville | Florida | United States |
| Leesburg | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Sunrise | Florida | United States |
| West Palm Beach | Florida | United States |
| Columbus | Georgia | United States |
| Park Ridge | Illinois | United States |
| Wichita | Kansas | United States |
| Baton Rouge | Louisiana | United States |
| Bangor | Maine | United States |
| Newton | Massachusetts | United States |
| Plymouth | Massachusetts | United States |
| Flowood | Mississippi | United States |
| Hattiesburg | Mississippi | United States |
| Creve Coeur | Missouri | United States |
| Princeton | New Jersey | United States |
| Springfield | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Brooklyn | New York | United States |
| Cedarhurst | New York | United States |
| Latham | New York | United States |
| Staten Island | New York | United States |
| Charlotte | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Oklahoma City | Oklahoma | United States |
| Portland | Oregon | United States |
| Norristown | Pennsylvania | United States |
| Plains | Pennsylvania | United States |
| East Providence | Rhode Island | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Bennington | Vermont | United States |
| Charlottesville | Virginia | United States |
| Williamsburg | Virginia | United States |
| Richland | Washington | United States |
| Geelong | Victoria | Australia |
| Leuven | Belgium |
| Kelowna | British Columbia | Canada |
| Halifax | Nova Scotia | Canada |
| Chatham | Ontario | Canada |
| Toronto | Ontario | Canada |
| Prague | Czechia |
| Rychnov nad Kněžnou | Czechia |
| Milan | Lombardy | Italy |
| Amsterdam | Netherlands |
| Bialystok | Poland |
| Warsaw | Poland |
| Johannesburg | Gauteng | South Africa |
| Pretoria | Gauteng | South Africa |
| Durban | KwaZulu-Natal | South Africa |
| Bellville | Western Cape | South Africa |
| George | Western Cape | South Africa |
| Somerset West | Western Cape | South Africa |
| Busan | South Korea |
| Incheon | South Korea |
| Seoul | South Korea |
| Terrassa | Barcelona | Spain |
| Burgos | Spain |
| Madrid | Spain |
| Salamanca | Spain |
| Glasgow | United Kingdom |
| Isleworth | United Kingdom |
| Northampton | United Kingdom |
| Penarth | United Kingdom |
| Southampton | United Kingdom |
| 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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| ID | Term |
|---|---|
| C573817 | 7-chloro-N-quinuclidin-3-yl-benzo(b)thiophene-2-carboxamide |
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