The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.
- 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
- Other causes of dementia
- Major structural brain disease
- Unstable medical condition or significant hepatic or renal disease
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease | ||
| Official Title ICMJE | 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 | ||
| Brief Summary | The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease. | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 3 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||
| Condition ICMJE | Moderate to Severe Alzheimer | ||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Terminated | ||
| Actual Enrollment ICMJE | 89 | ||
| Original Enrollment ICMJE | Not Provided | ||
| Study Completion Date ICMJE | Not Provided | ||
| Actual Primary Completion Date | August 2010 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 50 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Chile, United Kingdom | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00954590 | ||
| Other Study ID Numbers ICMJE | DIM19 | ||
| Has Data Monitoring Committee | Yes | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Medivation, Inc. | ||
| Study Sponsor ICMJE | Medivation, Inc. | ||
| Collaborators ICMJE | Pfizer | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Medivation, Inc. | ||
| Verification Date | September 2016 | ||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
