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This study will evaluate the safety and potential benefit of Dimebon as compared to placebo in patients with mild to moderate Alzheimer's Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dimebon | Experimental | Dimebon 20 mg three times a day x 26 weeks |
|
| Placebo | Placebo Comparator | Placebo 20 mg three times a day x 26 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimebon | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale - cognitive subscale | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Change | 26 weeks | |
| Safety Assessed By Number of Participants With Adverse Events | Adverse events will be assessed through physical examinations, electrocardiograms, and clinical laboratory data (chemistry panel, complete blood count (CBC) with differential, and urinalysis). The incidence of adverse events will be summarized by severity and relationship to study treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Research Center of Russian Academy of Medical Sciences | Moscow | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18640457 | Derived | Doody RS, Gavrilova SI, Sano M, Thomas RG, Aisen PS, Bachurin SO, Seely L, Hung D; dimebon investigators. Effect of dimebon on cognition, activities of daily living, behaviour, and global function in patients with mild-to-moderate Alzheimer's disease: a randomised, double-blind, placebo-controlled study. Lancet. 2008 Jul 19;372(9634):207-15. doi: 10.1016/S0140-6736(08)61074-0. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C010119 | latrepirdine |
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|
| 26 weeks |
| Pharmacokinetic (PK) parameter of Dimebon: Cmax | Cmax: Maximum concentration | Week 1, 2, 6, 12, 18, 24. Blood PK samples will be obtained pre-dose and 1 hour post-dose for each timepoint. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |