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

This study has been completed.
Information provided by (Responsible Party):
Medivation, Inc. Identifier:
First received: September 15, 2006
Last updated: November 9, 2015
Last verified: November 2015
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 Intervention Phase
Alzheimer's Disease
Drug: Dimebon
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression of Change [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Safety Assessed By Number of Participants With Adverse Events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    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.

  • 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. ] [ Designated as safety issue: Yes ]
    Cmax: Maximum concentration

Enrollment: 183
Study Start Date: September 2005
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00377715

Russian Federation
Mental Health Research Center of Russian Academy of Medical Sciences
Moscow, Russian Federation
Sponsors and Collaborators
Medivation, Inc.
  More Information

No publications provided

Responsible Party: Medivation, Inc. Identifier: NCT00377715     History of Changes
Other Study ID Numbers: DIM02
Study First Received: September 15, 2006
Last Updated: November 9, 2015
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Medivation, Inc.:
Dimebon, Alzheimer's Disease, Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies processed this record on December 01, 2015