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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Medivation, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00829816
First received: January 12, 2009
Last updated: April 14, 2009
Last verified: April 2009

January 12, 2009
April 14, 2009
December 2008
March 2009   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00829816 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
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)

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Dimebon
    PO 3 times daily
  • Drug: Placebo
    Placebo, PO, TID
  • Experimental: Dimebon
    20 mg Dimebon PO TID
    Intervention: Drug: Dimebon
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
44
June 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00829816
DIM17
No
Stewart Hallett, MBA / Senior Director, Clinical Operations, Medivation, Inc.
Medivation, Inc.
Not Provided
Not Provided
Medivation, Inc.
April 2009

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