Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The study is designed to investigate the efficacy, safety and tolerability of SB-742457 versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an experimental treatment which increases the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.
Assessment of cognition and global function after 24 weeks treatment [ Time Frame: 24 weeks ]
Secondary Outcome Measures
Assessment of cognition and global function after 12 and 24 weeks treatment. Activities of daily living, assessment of depressive symptoms. Safety and tolerability. Pharmacokinetics and exploratory pharmacogenetics. [ Time Frame: 24 weeks ]
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Ages Eligible for Study:
50 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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 a documented 6-month history of AD symptoms
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 pregnancy testing and approved form of birth control.
Diagnosis of possible, probable or definite vascular dementia.
History/evidence of any other CNS disorder that could be interpreted as a cause of dementia
History of known or suspected seizures, loss of consciousness or significant head trauma
Subjects with ECG, blood pressure and laboratory values outside of protocol criteria are excluded.
Subjects with known photosensitivity
Subjects with a history of 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.