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Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Medivation, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00704782
First received: June 23, 2008
Last updated: June 10, 2009
Last verified: June 2009
History of Changes
  Purpose

The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease.


Condition Intervention Phase
Alzheimer's Disease
 Drug: dimebon
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • To assess the safety of Dimebon in combination with donepezil (Aricept) [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 21
Study Start Date: May 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dimebon
    Dimebon orally three times daily
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alzheimer's disease
  • On donepezil (Aricept)
  • Caregiver who cares for the patient at least 5 days per week

Exclusion Criteria:

  • Unstable medical illnesses or significant hepatic or renal disease
  • Other primary psychiatric or neurological disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00704782

Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Xenoscience, Inc.
Phoenix, Arizona, United States, 85004
Sun Health Research Institute
Sun City, Arizona, United States, 85351
Sponsors and Collaborators
Medivation, Inc.
  More Information

No publications provided

Responsible Party: Mohammad Hirmand, Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00704782     History of Changes
Other Study ID Numbers: DIM13
Study First Received: June 23, 2008
Last Updated: June 10, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013