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This study compares the drug SB-742457, added to existing Donepezil therapy, with placebo in people with mild-to-moderate Alzheimer's Disease. It included patients on Donepezil for at least 6 months with a regular caregiver. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.