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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Medivation, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00829816
First received: January 12, 2009
Last updated: April 14, 2009
Last verified: April 2009
History of Changes
  Purpose

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 Intervention Phase
Alzheimer's Disease
 Drug: Dimebon
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • To assess the safety and tolerability of orally administered Dimebon in patients with Alzheimer's disease on a stable dose and regimen of memantine, or memantine plus donepezil.

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.

Estimated Enrollment: 44
Study Start Date: December 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dimebon
20 mg Dimebon PO TID
 Drug: Dimebon
PO 3 times daily
Placebo Comparator: 2 Drug: Placebo
Placebo, PO, TID

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Stewart Hallett, MBA / Senior Director, Clinical Operations, Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00829816     History of Changes
Other Study ID Numbers: DIM17
Study First Received: January 12, 2009
Last Updated: April 14, 2009
Health Authority: United States: Food and Drug Administration

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memantine
Donepezil
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Nootropic Agents

ClinicalTrials.gov processed this record on May 23, 2013