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

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

Tracking Information

• First Submitted Date: January 12, 2009
• First Posted Date: January 27, 2009
• Last Update Posted Date: November 10, 2015
• Study Start Date: December 2008
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2015)

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.

• Original Primary Outcome Measures (submitted: January 23, 2009): 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.

Current Secondary Outcome Measures (submitted: November 6, 2015)

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.

• Original Secondary Outcome Measures (submitted: January 23, 2009): 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.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Alzheimer's Disease

Intervention

• Drug: Dimebon
• Drug: Placebo

Study Arms

• Experimental: Dimebon
  20 mg dimebon by mouth 3 times per day
  Intervention: Drug: Dimebon
• Placebo Comparator: Placebo
  20 mg placebo by mouth 3 times per day
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 6, 2015): 46
• Original Estimated Enrollment (submitted: January 23, 2009): 44
• Actual Study Completion Date: August 2010
• Actual Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00829816
• Other Study ID Numbers: DIM17
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medivation, Inc.
• Study Sponsor: Medivation, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Medivation, Inc.
• Verification Date: November 2015