A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease
NCT00954590
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- 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
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Descriptive Information | |||
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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 |