A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
Status: | Completed |
---|---|
Conditions: | Alzheimer Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 50 - 85 |
Updated: | 12/9/2017 |
Start Date: | July 1, 2008 |
End Date: | November 16, 2010 |
Study AZ3110866, a Fixed Dose Study of SB-742457 Versus Placebo When Added to Existing Donepezil Treatment in Subjects With Mild-to-moderate Alzheimer's Disease
The study is designed to investigate the safety and efficacy of SB-742457 when added to
stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.
stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.
Inclusion Criteria:
- Subjects and their caregivers must provide informed consent prior to study entry.
- Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's
disease with no evidence of disorders that are thought to be the cause of, or
contributing to the severity of the subject's dementia and a documented history of at
least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2
months.
- Subjects must have a regular caregiver who is willing to attend visits, oversee the
subject's compliance with the study and report on the subject's status.
- Female subjects of child-bearing potential must agree to abstinence or an approved
form of birth control.
- Subjects must have adequate blood pressure and laboratory values.
Exclusion Criteria:
- Subjects with a diagnosis of possible, probable or definite vascular dementia may not
participate.
- Subjects with known hypersensitivity to sunlight or a history of seizures, previous
exposure to SB-742457, taking agents for which there is a theoretical risk of
interaction with SB-742457, or taking medication for Alzheimer's disease or centrally
acting agents which might impact study outcomes may not participate.
We found this trial at
15
sites
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