Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2009 by Medivation, Inc..
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Medivation, Inc.

ClinicalTrials.gov Identifier:

NCT00829816

First received: January 12, 2009

Last updated: April 14, 2009

Last verified: April 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2009
Last Updated Date	April 14, 2009
Start Date ^ICMJE	December 2008
Estimated Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 23, 2009)	To assess the safety and tolerability of orally administered Dimebon in patients with Alzheimer's disease on a stable dose and regimen of memantine, or memantine plus donepezil.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00829816 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 23, 2009)	To assess the steady-state pharmacokinetics (PK) of orally-administered Dimebon in patients with AD on a stable dose and regimen of memantine, or memantine plus donepezil.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
Official Title ^ICMJE	A Multi-Center Phase 1 Study of the Safety and Tolerability of Dimebon in Alzheimer's Disease Patients on Memantine (Cohort 1) and Memantine Plus Donepezil (Cohort 2)
Brief Summary	The purpose of this study is to evaluate the safety and tolerability of Dimebon given to Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: Dimebon PO 3 times daily Drug: Placebo Placebo, PO, TID
Study Arm (s)	Experimental: Dimebon 20 mg Dimebon PO TID Intervention: Drug: Dimebon Placebo Comparator: 2 Intervention: Drug: Placebo
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	44
Estimated Completion Date	June 2009
Estimated Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Alzheimer's disease On Memantine Caregiver who is willing to accompany the patient to all clinic visits 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	NCT00829816
Other Study ID Numbers ^ICMJE	DIM17
Has Data Monitoring Committee	No
Responsible Party	Stewart Hallett, MBA / Senior Director, Clinical Operations, Medivation, Inc.
Study Sponsor ^ICMJE	Medivation, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medivation, Inc.
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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