Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil - Full Text View

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: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Memantine Memantine hydrochloride Donepezil hydrochloride Donepezil

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

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 (AD) on a stable dose and regimen of memantine, or memantine plus donepezil. [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
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. [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
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.


Enrollment:	46
Study Start Date:	December 2008
Study Completion Date:	August 2010
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	50 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00829816 History of Changes
Other Study ID Numbers:	DIM17
Study First Received:	January 12, 2009
Last Updated:	November 6, 2015
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 Neurocognitive Disorders Mental Disorders Memantine Donepezil Antiparkinson Agents	Anti-Dyskinesia Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Cholinesterase Inhibitors Enzyme Inhibitors Cholinergic Agents Nootropic Agents

ClinicalTrials.gov processed this record on September 30, 2016