Back to resultsSafety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dimebon
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimers disease, donepezil, memantine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dimebon
Placebo
Arm Description
20 mg dimebon by mouth 3 times per day
20 mg placebo by mouth 3 times per day
Outcomes
Primary Outcome Measures
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.
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00829816
Brief Title
Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivation, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimers disease, donepezil, memantine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dimebon
Arm Type
Experimental
Arm Description
20 mg dimebon by mouth 3 times per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 mg placebo by mouth 3 times per day
Intervention Type
Drug
Intervention Name(s)
Dimebon
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
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