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

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ClinicalTrials.gov Identifier: NCT00829816
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Medivation, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Dimebon Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : August 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dimebon
20 mg dimebon by mouth 3 times per day
 Drug: Dimebon
Placebo Comparator: Placebo
20 mg placebo by mouth 3 times per day
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 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 :
  1. 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. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829816


Locations
United States, California
Los Alamitos, California, United States, 90720
National City, California, United States, 91950
United States, Florida
Delray Beach, Florida, United States, 33445
Orlando, Florida, United States, 32806
Sponsors and Collaborators
Medivation, Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00829816     History of Changes
Other Study ID Numbers: DIM17
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by Medivation, Inc.:
Alzheimers disease
donepezil
memantine

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Memantine
Cholinesterase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents