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The objective of this study is to evaluate the safety and efficacy as assessed by the Alzheimers Disease Assessment Scale-cognitive subscale 13-item (ADAS-cog-13) of two doses of MT-4666 or placebo administered daily for 24 weeks to subjects with mild to moderate Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-4666 Low Dose | Experimental | low dose |
|
| MT-4666 High Dose | Experimental | high dose |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-4666 | Drug | low dose, high dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ADAS-cog-13 | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) | Baseline and Week 24 | |
| Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) | Baseline and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu Nakamura, M.D., Ph.D. | Kagawa University School of Medicine | Study Director |
| Akira Homma, M.D. | Tokyo Dementia Care Research and Training Center | Study Director |
| Shun Shimohama, M.D., D. Med. SC | Sapporo Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanto | Japan |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| Placebo |
| Drug |
|
| Change from baseline in Alzheimers Disease Assessment Scale-cognitive subscale 11-item (ADAS-cog-11) | Baseline and Week 24 |
| Change from baseline in Mini-Mental State Examination (MMSE) | Baseline and Week 24 |
| Change from baseline in Neuropsychiatric Inventory (NPI) | Baseline and Week 24 |
| Change from baseline in Modified Crichton Scale | Baseline and Week 24 |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |