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A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease
This study is currently recruiting participants.
Study NCT00912288   Information provided by Pfizer
First Received: June 1, 2009   Last Updated: March 3, 2010   History of Changes

June 1, 2009
March 3, 2010
September 2009
October 2011   (final data collection date for primary outcome measure)
  • Change from baseline in the Severe Impairment Battery [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in ADCS-Activities of Daily Living (severe) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00912288 on ClinicalTrials.gov Archive Site
  • Change from baseline in the Neuropsychiatric Inventory [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Clinician's Global Impression of Change (plus caregiver input) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Mini-mental State Exam [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline Resource Utilization in Dementia [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in EuroQoL - 5 Domain assessment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Safety and Tolerability including adverse events and summary of clinically important changes in clinical safety laboratory assessments, electrocardiograms, and vital signs [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
Same as current
 
A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 26-Week Trial To Evaluate The Efficacy And Safety Of Dimebon In Patients With Moderate-To-Severe Alzheimer's Disease

No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Alzheimer Disease
  • Drug: Dimebon 20 mg po TID
    Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks
    Other Name: PF-01913539
  • Drug: Placebo po TID
    Placebo (matched to Dimebon) po for 26 weeks
  • Dimebon: Experimental
    Intervention: Drug: Dimebon 20 mg po TID
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo po TID
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
576
November 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Are men and women ≥ 50 years of age with a diagnosis of Alzheimers disease.
  • Have a Mini-Mental State Exam between 5 and 14 inclusive.
  • Have been taking the medication memantine (ie., Namenda) for at least six months prior to this study.
  • Must have a caregiver who assists the patient at least five days per week for at least three hours per day, who can accompany patient to study visits, and who has an intimate knowledge of the patient's health states and personal care.

Exclusion Criteria:

  • Have taken medicines for Alzheimers disease other than memantine (e.g., donepezil, rivastigmine, galantamine, tacrine) within 2 months prior to this study.
  • Dementia other than Alzheimers disease.
  • Any medical condition or reason that interferes with the ability of the patient to participate in or complete the trial or places the patient at undue risk, as judged by the study doctor.
Both
50 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Canada,   Germany,   Portugal,   Slovakia,   Spain,   Turkey
 
NCT00912288
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
B1451006
Pfizer
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2010

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