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

Tracking Information
First Received Date ^ICMJE	June 23, 2008
Last Updated Date	June 10, 2009
Start Date ^ICMJE	May 2008
Estimated Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2008)	To assess the safety of Dimebon in combination with donepezil (Aricept) [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00704782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease
Official Title ^ICMJE	An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: dimebon Dimebon orally three times daily
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	21
Estimated Completion Date	December 2008
Estimated Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00704782
Other Study ID Numbers ^ICMJE	DIM13
Has Data Monitoring Committee	Not Provided
Responsible Party	Mohammad Hirmand, Medivation, Inc.
Study Sponsor ^ICMJE	Medivation, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medivation, Inc.
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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