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

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NCT00829816

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Study Location
Los Alamitos, California, 90720, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Alzheimer's disease

- On Memantine

- Caregiver who is willing to accompany the patient to all clinic visits

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Unstable medical illnesses or significant hepatic or renal disease


- Other primary psychiatric or neurological disorders

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Dimebon
  • Drug: Placebo
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2015)		46
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2009)		44
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00829816
Other Study ID Numbers  ICMJE DIM17
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medivation, Inc.
Study Sponsor  ICMJE Medivation, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medivation, Inc.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP