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

This study is currently recruiting participants.

Verified by Medivation, July 2008

Sponsored by:	Medivation
Information provided by:	Medivation
ClinicalTrials.gov Identifier:	NCT00704782

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 I

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Donepezil E 2020 Dimebolin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease

Further study details as provided by Medivation:

Primary Outcome Measures:

To assess the safety of Dimebon in combination with donepezil (Aricept) [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	21
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Dimebon orally three times daily

Eligibility

Ages Eligible for Study:	50 Years and older
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704782

Contacts

Contact: Mohammad Hirmand, MD

415-829-4126

mohammad.hirmand@medivation.com

Locations

United States, Arizona
Banner Alzheimer's Institute	Recruiting
Phoenix, Arizona, United States, 85006
Contact 602-239-6900
Principal Investigator: Pierre N Tariot, MD
Sun Health Research Institute	Recruiting
Sun City, Arizona, United States, 85351
Contact 623-875-6500
Principal Investigator: Marwan N Sabbagh, MD
Barrow Neurological Institute	Recruiting
Phoenix, Arizona, United States, 85013
Contact 602-406-3719
Principal Investigator: Patricio Reyes, MD
Xenoscience, Inc.	Recruiting
Phoenix, Arizona, United States, 85004
Contact 602-274-9500
Principal Investigator: Stephen S. Flitman, MD

Sponsors and Collaborators

Medivation

More Information

Responsible Party:	Medivation, Inc. ( Mohammad Hirmand )
Study ID Numbers:	DIM13
Study First Received:	June 23, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00704782
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009