A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease (CONTACT)
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ClinicalTrials.gov Identifier: NCT00954590 |
Recruitment Status
:
Terminated
First Posted
: August 7, 2009
Last Update Posted
: September 27, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Moderate to Severe Alzheimer | Drug: Dimebon (latrepirdine) Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 89 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official 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 |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Dimebon (latrepirdine)
Dimebon, 20 mg orally three times daily
|
Drug: Dimebon (latrepirdine)
20 mg orally three times daily
|
Placebo Comparator: Placebo
Placebo orally three times daily
|
Drug: Placebo
Placebo orally three times daily
|
- Neuropsychiatric Inventory (NPI) [ Time Frame: 26 weeks post baseline ]To evaluate the efficacy of dimebon (latrepirdine) as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI)
- Activities of Daily Living (severe) (ADCS ADLsev) [ Time Frame: 26 weeks post baseline ]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).

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954590
Chile | |
Santiago, Chile | |
United Kingdom | |
Glasgow, Scotland, United Kingdom |
Responsible Party: | Medivation, Inc. |
ClinicalTrials.gov Identifier: | NCT00954590 History of Changes |
Other Study ID Numbers: |
DIM19 |
First Posted: | August 7, 2009 Key Record Dates |
Last Update Posted: | September 27, 2016 |
Last Verified: | September 2016 |
Additional relevant MeSH terms:
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |