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The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with donepezil when using a computerized test battery. The results at one month will be compared with the results at 3 months to evaluate this.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days) |
|
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil | Drug | 5 mg capsule, orally, once daily, first 14 days of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| CogState Computerized Neurological Test Battery | Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98 |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychological Test Battery (NTB) | Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97 | |
| Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malene Jensen | Study Delievery Director, AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ottawa | Ontario | Canada | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23763450 | Derived | Karin A, Hannesdottir K, Jaeger J, Annas P, Segerdahl M, Karlsson P, Sjogren N, von Rosen T, Miller F. Psychometric evaluation of ADAS-Cog and NTB for measuring drug response. Acta Neurol Scand. 2014 Feb;129(2):114-22. doi: 10.1111/ane.12153. Epub 2013 Jun 13. |
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| Donepezil | Drug | 10 mg, orally, once daily, for remaining 70 days of treatment |
|
|
| Placebo to match Aricept | Drug | Placebo capsule, orally, 84 days of treatment |
|
| Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97 |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | Tl. of 4 times: Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97 |
| Gatineau |
| Quebec |
| Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Québec | Quebec | Canada |
| Reearch Site | Québec | Canada |
| Research Site | Callao | Lima | Peru |
| Research Site | Callao | Peru |
| Research Site | Lima | Peru |
| Research Site | Chojnice | Poland |
| Research Site | Gdansk | Poland |
| Research Site | Kalisz | Poland |
| Research Site | Piła | Poland |
| Research Site | Poznan | Poland |
| Research Site | Sopot | Poland |
| Research Site | Ścinawa | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Cape Town | Western Cape | South Africa |
| Research Site | Roodepoort | 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 |
|---|---|
| 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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