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

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 |
- 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.
- 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.

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |