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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 23, 2008

Last Updated Date

April 14, 2009

Start Date ^†

May 2008

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00704782 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Alzheimer's Disease

Intervention ^†

Drug: dimebon

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

December 2008

Estimated Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Mohammad Hirmand, MD

415-829-4126

mohammad.hirmand@medivation.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00704782

Responsible Party

Mohammad Hirmand, Medivation, Inc.

Secondary IDs ^††

Study Sponsor ^†

Medivation, Inc.

Collaborators ^††

Investigators ^†

Information Provided By

Medivation, Inc.

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.