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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease.
This study is a multicenter Phase 3, randomized, double-blind, placebo-controlled safety and efficacy study of Dimebon treatment in subjects with Huntington disease (HD). The study will evaluate Dimebon 20 mg three times daily (TID) administered orally (PO) for six months (26 weeks) compared with matching placebo TID for the primary safety and efficacy analyses. Safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, safety laboratory evaluations, and 12-lead electrocardiogram(ECG)assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Dimebon | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimebon | Drug | 20 mg Dimebon orally TID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE | Week 26 | |
| A comparison of the distributions of the CIBIC-plus (ADCS CGIC)in the Dimebon 20 mg TID treatment group and the placebo group | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the NPI | Week 26 | |
| A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL |
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Inclusion Criteria:
Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36
Have cognitive impairment as noted by the following:
Are willing and able to give informed consent
Aged 30 years or older
Have a caregiver who assists/spends time with the subject at least five days per week for at least three hours per day and has intimate knowledge of the subject's cognitive, functional, and emotional states, and of the subject's personal care.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85259 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23108692 | Derived | HORIZON Investigators of the Huntington Study Group and European Huntington's Disease Network. A randomized, double-blind, placebo-controlled study of latrepirdine in patients with mild to moderate Huntington disease. JAMA Neurol. 2013 Jan;70(1):25-33. doi: 10.1001/2013.jamaneurol.382. |
| Label | URL |
|---|---|
| Study website | View source |
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| Other |
Orally TID |
|
| Week 26 |
| A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the UHDRS'99 Total Motor Score | Week 26 |
| Davis |
| California |
| 95616 |
| United States |
| Irvine | California | 92697 | United States |
| La Jolla | California | 92161 | United States |
| San Francisco | California | 94143 | United States |
| Gainsville | Florida | 32610 | United States |
| Miami | Florida | 33136 | United States |
| Boise | Idaho | 83702 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Kansas City | Kansas | 66160 | United States |
| Wichita | Kansas | 67206 | United States |
| Charlestown | Massachusetts | 02129 | United States |
| Golden Valley | Minnesota | 55427 | United States |
| St Louis | Missouri | 63110 | United States |
| New York | New York | 10032 | United States |
| Rochester | New York | 14620 | United States |
| Durham | North Carolina | 27705 | United States |
| Winstom-Salem | North Carolina | 27157 | United States |
| Cleveland | Ohio | 44195 | United States |
| Columbus | Ohio | 43210 | United States |
| Portland | Oregon | 97201 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Wentworthville | New South Wales | Australia |
| Melbourne | Victoria | Australia |
| Perth | Australia |
| Vancouver | British Columbia | Canada |
| London | Ontario | Canada |
| Montreal | Quebec | Canada |
| Copenhagen | Denmark |
| Oberer Eslebberg | Ulm | Germany |
| Aachen | Germany |
| Bochum | Germany |
| Hamburg | Germany |
| Stockholm | Sweden |
| Birmingham | United Kingdom |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C010119 | latrepirdine |
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