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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: Dimebon

• Registration Number: NCT00829816
• Lead Sponsor: Medivation, Inc.

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 available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-27
• Primary Completion: 2009-04
• Study Completion: 2010-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-06
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	20 mg placebo by mouth 3 times per day
Dimebon	Dimebon	20 mg dimebon by mouth 3 times per day

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of orally administered dimebon in patients with Alzheimer's disease (AD) on a stable dose and regimen of memantine, or memantine plus donepezil.	up to 28 days	Treatment discontinuation due to adverse events, the frequency and severity of adverse events, and clinically significant changes in safety assessments (including physical examination findings, vital signs, laboratory values, and ECGs) in the dimebon group will be compared to those reported in the placebo group.

Secondary Outcome Measures

Name	Time	Method
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.	up to 28 days	The following key parameters will be used to assess the steady-state PK of dimebon: maximum plasma concentration (Cmax), time to maximum plasma concentration (tmax), Ctrough, area under the curve (AUC), and peak-to-trough ratio.