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The primary objective of the study is to evaluate the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment.
The secondary objectives of the study are to evaluate the safety of T-817MA and the activities of daily living (assessed with the ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | T-817MA once daily |
|
| 2 | Placebo Comparator | Placebo once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-817MA | Drug | 224 mg T-817 MA once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the efficacy of T-817MA in AD patients to treat dementia. Efficacy will be cognitive function, as measured by the ADAS-cog cognitive assessment. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objectives are to evaluate the safety of T-817MA and the activities of daily living (ADCS-ADL) of AD patients taking T-817MA, and to evaluate the efficacy of T-817MA in AD patients with an overall global assessment using the ADCS-CGIC. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006 | United States | ||
| Northwest NeuroSpecialists |
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| Drug |
Placebo once daily |
|
| Tucson |
| Arizona |
| 85741 |
| United States |
| Collaborative Neuroscience Network, Inc. | Garden Grove | California | 92845 | United States |
| Southwest Institute for Clinical Research, Inc. | Rancho Mirage | California | 92270 | United States |
| Pacific Research Network, Inc. | San Diego | California | 92103 | United States |
| San Francisco Clinical Research Center | San Francisco | California | 94109 | United States |
| Radiant Research | Denver | Colorado | 80239 | United States |
| Geriatric and Adult Psychiatry, LCC | Hamden | Connecticut | 06518 | United States |
| Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | 06851 | United States |
| NeuroPsychiatric Center of the Palm Beaches | Boynton Beach | Florida | 33426 | United States |
| Galiz Research | Miami Springs | Florida | 33166 | United States |
| Anchor Research Center | Naples | Florida | 34102 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | United States |
| Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute | Tampa | Florida | 33613 | United States |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | United States |
| Columbus Research & Wellness Institute | Columbus | Georgia | 31907 | United States |
| Agewell | Indianapolis | Indiana | 46260 | United States |
| Cleveland Clinic - Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| Memory Enhancement Center of America | Toms River | New Jersey | 08755 | United States |
| Brooklyn Medical Institute | Brooklyn | New York | 11214 | United States |
| SPRI Clinical Trials | Brooklyn | New York | 11235 | United States |
| Alzheimer's Disease Center, U. of Rochester Medical Center | Rochester | New York | 14620 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| The Alzheimer's Memory Center | Charlotte | North Carolina | 28211 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | United States |
| Clinical Trials of America, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| The Clinical Trials Center | Jenkintown | Pennsylvania | 19046 | United States |
| CRI Worldwide, LLC | Philadelphia | Pennsylvania | 19139 | United States |
| Innovative Clinical Trials | San Antonio | Texas | 78229 | United States |
| IPC Research | Waukesha | Wisconsin | 53188 | United States |
| St. Joseph's Hospital | Saint John | New Brunswick | E2L 3L6 | Canada |
| Toronto Memory Program | Toronto | Ontario | M3B 2S7 | Canada |
| 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 |
|---|---|
| C503102 | 1-(3-(2-(1-benzothiophen-5-yl) ethoxy) propyl)-3-azetidinol maleate |
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