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

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: dimebon

• Registration Number: NCT00704782
• Lead Sponsor: Medivation, Inc.

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 available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2015-11
• Disposition First Submitted: 2015-11-13
• Disposition First Submitted QC: 2015-11-13
• Last Update Submitted: 2015-11-13
• Disposition First Posted: 2015-12-10
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dimebon	dimebon	20 mg by mouth 3 times a day

Primary Outcome Measures

Name	Time	Method
To assess the safety of Dimebon in combination with donepezil (Aricept)	week 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation

Trial Locations

Locations (4)

Xenoscience, Inc.; 🇺🇸 Phoenix, Arizona, United States

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States