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

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ClinicalTrials.gov Identifier: NCT00704782
Recruitment Status : Terminated (The study was halted after a Phase 3 study of dimebon failed to show efficacy.)
First Posted : June 25, 2008
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Medivation, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Drug: dimebon Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2008
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Donepezil
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dimebon
20 mg by mouth 3 times a day
Drug: dimebon



Primary Outcome Measures :
  1. To assess the safety of Dimebon in combination with donepezil (Aricept) [ Time Frame: week 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00704782


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

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00704782     History of Changes
Other Study ID Numbers: DIM13
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents