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Trial record 17 of 97 for:    Medivation

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

This study has been terminated.
(The study was halted after a Phase 3 study of dimebon failed to show efficacy.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704782
First Posted: June 25, 2008
Last Update Posted: December 10, 2015
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.
Information provided by (Responsible Party):
Medivation, Inc.
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation ]

Enrollment: 50
Study Start Date: April 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dimebon
20 mg by mouth 3 times a day
Drug: dimebon

  Eligibility

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.


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
  Contacts and Locations
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.
  More Information

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00704782     History of Changes
Other Study ID Numbers: DIM13
First Submitted: June 23, 2008
First Posted: June 25, 2008
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