Status:
TERMINATED
A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
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 moder...
Detailed Description
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 no...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00912288
Start Date
September 1 2009
End Date
August 1 2010
Last Update
October 2 2012
Active Locations (47)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
2
Pfizer Investigational Site
Costa Mesa, California, United States, 92626
3
Pfizer Investigational Site
Encino, California, United States, 91316
4
Pfizer Investigational Site
Los Alamitos, California, United States, 90720