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:
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00704782
First received: June 23, 2008
Last updated: November 13, 2015
Last verified: November 2015
  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: 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:


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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
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 ClinicalTrials.gov identifier: 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 
Study First Received: June 23, 2008
Last Updated: November 13, 2015
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
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents

ClinicalTrials.gov processed this record on August 23, 2016