A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - Any
Updated:12/8/2018
Start Date:February 2009
End Date:January 2010

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A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer's Disease

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 placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with
Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the
study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label
extension study.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
86
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Williamsburg, Virginia 23185
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Albuquerque, New Mexico 87108
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Altoona, Pennsylvania 16601
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Amherst, New York 14226
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Atlanta, Georgia 30309
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Beaver, Pennsylvania 15009
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Bradenton, Florida 34205
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Bridgeville, Pennsylvania 15017
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Buffalo, New York 14222
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Burr Ridge, Illinois 60527
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Carrollton, Texas 75010
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Charleston, South Carolina 29425
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Charleston, West Virginia 25304
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Charlotte, North Carolina 28277
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Cincinnati, Ohio 45242
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Clearwater, Florida 33756
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Daytona Beach, Florida 32114
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Eatontown, New Jersey 07724
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Elk Grove Village, Illinois 60007
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Fargo, North Dakota 58104
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Flowood, Mississippi 39232
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Fort Myers, Florida 33916
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Fort Wayne, Indiana 46805
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Fort Worth, Texas 76104
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Franklin, Tennessee 37067
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Grand Prairie, Texas 75052
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Greenfield, Indiana 46140
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Grove City, Pennsylvania 16127
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Houston, Texas 77030
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Mobile, Alabama 36608
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Murrells Inlet, South Carolina 29576
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Naples, Florida 34102
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