COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00377715
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : November 11, 2015
Information provided by (Responsible Party):
Medivation, Inc.

Brief Summary:
This study will evaluate the safety and potential benefit of Dimebon as compared to placebo in patients with mild to moderate Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Dimebon Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Double-Blind, Placebo-Controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease
Study Start Date : September 2005
Actual Primary Completion Date : August 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dimebon
Dimebon 20 mg three times a day x 26 weeks
Drug: Dimebon
Placebo Comparator: Placebo
Placebo 20 mg three times a day x 26 weeks
Drug: Placebo

Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression of Change [ Time Frame: 26 weeks ]
  2. Safety Assessed By Number of Participants With Adverse Events [ Time Frame: 26 weeks ]
    Adverse events will be assessed through physical examinations, electrocardiograms, and clinical laboratory data (chemistry panel, complete blood count (CBC) with differential, and urinalysis). The incidence of adverse events will be summarized by severity and relationship to study treatment.

  3. Pharmacokinetic (PK) parameter of Dimebon: Cmax [ Time Frame: Week 1, 2, 6, 12, 18, 24. Blood PK samples will be obtained pre-dose and 1 hour post-dose for each timepoint. ]
    Cmax: Maximum concentration

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Males or females greater than or equal to 50 years of age.
  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:

  1. Major structural brain disease
  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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00377715

Layout table for location information
Russian Federation
Mental Health Research Center of Russian Academy of Medical Sciences
Moscow, Russian Federation
Sponsors and Collaborators
Medivation, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Medivation, Inc. Identifier: NCT00377715    
Other Study ID Numbers: DIM02
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: November 2015
Keywords provided by Medivation, Inc.:
Dimebon, Alzheimer's Disease, Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders