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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.
This study was terminated on May 7, 2010 due to modification of the dimebon development plan following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Costa Mesa, California, United States
Pfizer Investigational Site
Encino, California, United States
Pfizer Investigational Site
Los Alamitos, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
Newport Beach, California, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Pfizer Investigational Site
Brooksville, Florida, United States
Pfizer Investigational Site
Delray Beach, Florida, United States
Start Date
September 1, 2009
Primary Completion Date
August 1, 2010
Completion Date
August 1, 2010
Last Updated
October 2, 2012
86
ACTUAL participants
Dimebon 20 mg po TID
DRUG
Placebo po TID
DRUG
Lead Sponsor
Pfizer
Collaborators
NCT04123314
NCT07178210
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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