Moderate to Severe Alzheimer Clinical Trial
— CONTACTOfficial title:
CONTACT: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Six-Month Safety and Efficacy Study of Dimebon in Patients With Moderate-to-Severe Alzheimer's Disease
| NCT number | NCT00954590 |
| Other study ID # | DIM19 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 3 |
| First received | August 6, 2009 |
| Last updated | September 24, 2016 |
| Start date | October 2009 |
| Verified date | September 2016 |
| Source | Medivation, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.
| Status | Terminated |
| Enrollment | 89 |
| Est. completion date | |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - Moderate-to-Severe Alzheimer's disease - Mini-Mental State Examination (MMSE) Score between 5 to 14, inclusive - Stable on donepezil for at least 6 months Exclusion Criteria: - Other causes of dementia - Major structural brain disease - Unstable medical condition or significant hepatic or renal disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Medivation, Inc. | Pfizer |
Chile, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Neuropsychiatric Inventory (NPI) | To evaluate the efficacy of dimebon (latrepirdine) as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI) | 26 weeks post baseline | No |
| Primary | Activities of Daily Living (severe) (ADCS ADLsev) | To evaluate the efficacy of dimebon as compared to placebo on a measure of self-care and daily function, the Alzheimer's Disease Cooperative Study - Activities of Daily Living (severe) (ADCS ADLsev). | 26 weeks post baseline | No |