Status:
COMPLETED
A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Medivation, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or plac...
Eligibility Criteria
Inclusion
- Diagnosis of Alzheimer's Disease.
- MMSE 12-26 inclusive.
- If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
- If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.
Exclusion
- Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region \[e.g., thalamus, hippocampus\]).
- Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.
- Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
- Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
742 Patients enrolled
Trial Details
Trial ID
NCT00838110
Start Date
February 1 2009
End Date
January 1 2010
Last Update
December 6 2018
Active Locations (118)
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1
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
2
Pfizer Investigational Site
Northport, Alabama, United States, 35476
3
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
4
Pfizer Investigational Site
Oceanside, California, United States, 92056