Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease
NCT ID: NCT00377715
Last Updated: 2015-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dimebon
Dimebon 20 mg three times a day x 26 weeks
Dimebon
Placebo
Placebo 20 mg three times a day x 26 weeks
Placebo
Interventions
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Dimebon
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Alzheimer's Disease according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) and Mini Mental State Exam between 10 and 24, inclusive and Modified Hachinski Ischemia Score less than or equal to 4.
3. Brain imaging such as MRI and/or CT within one year of enrollment.
4. Subjects must have a guardian or caregiver who assists the subject at least 5 days per week (at least 3 hours/day).
5. Subjects must be able to cooperate with drug administration (including the ability to ingest oral medications) and study procedures and abide by study restrictions.
6. Subjects must have at least 6 years of prior education and should have previously (in pre-Alzheimer's condition) been capable of reading, writing and communicating effectively with others.
7. Subjects must be willing and able to give informed consent or have a mentally competent legal representative authorized to provide informed consent on their behalf.
8. Residence in an assisted care facility is allowed if subject is living independently.
Exclusion Criteria
2. Major medical illness or unstable medical condition within 6 months of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions.
3. Residence in a nursing home or assisted care facility that provides the subject with 24-hour care and supervision.
4. Women who are pregnant, nursing, or if of child-bearing potential not using a medically accepted, highly effective method of birth control.
5. Active alcohol dependence or drug abuse.
6. Use of the following medications within 60 days prior to enrollment:cognition enhancing agents, narcotic analgesics, low potency neuroleptics, antihypertensive agents with frequent Central Nervous System (CNS) side effects, anti-Parkinsonian medications, medications with central anticholinergic activity, medications for epilepsy, lithium.
7. Participation in an investigational drug or device study within 30 days prior to study entry, or 60 days prior to study entry if the investigational drug study involved therapy for Alzheimer's Disease.
50 Years
ALL
No
Sponsors
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Medivation, Inc.
INDUSTRY
Responsible Party
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Locations
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Mental Health Research Center of Russian Academy of Medical Sciences
Moscow, Moscow, Russia
Countries
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References
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Doody RS, Gavrilova SI, Sano M, Thomas RG, Aisen PS, Bachurin SO, Seely L, Hung D; dimebon investigators. Effect of dimebon on cognition, activities of daily living, behaviour, and global function in patients with mild-to-moderate Alzheimer's disease: a randomised, double-blind, placebo-controlled study. Lancet. 2008 Jul 19;372(9634):207-15. doi: 10.1016/S0140-6736(08)61074-0.
Other Identifiers
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DIM02
Identifier Type: -
Identifier Source: org_study_id
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