Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease

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NCT00704782

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Study Location
Xenoscience, Inc.
Phoenix, Arizona, 85004, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[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 donepezil (Aricept)

- Caregiver who cares for the patient at least 5 days per week

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 Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease
Official Title  ICMJE An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease
Brief Summary The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: dimebon
Study Arms  ICMJE Experimental: Dimebon
20 mg by mouth 3 times a day
Intervention: Drug: dimebon
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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 13, 2015)		50
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2008)		21
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Alzheimer's disease
  • On donepezil (Aricept)
  • Caregiver who cares for the patient at least 5 days per week

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 NCT00704782
Other Study ID Numbers  ICMJE DIM13
Has Data Monitoring Committee Not Provided
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