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

June 23, 2008
November 13, 2015
April 2008
August 2010   (final data collection date for primary outcome measure)
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 ]
To assess the safety of Dimebon in combination with donepezil (Aricept) [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00704782 on ClinicalTrials.gov Archive Site
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Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease
An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: dimebon
Experimental: Dimebon
20 mg by mouth 3 times a day
Intervention: Drug: dimebon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00704782
DIM13
Not Provided
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Medivation, Inc.
Medivation, Inc.
Not Provided
Not Provided
Medivation, Inc.
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP