A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00710684

Run by

GlaxoSmithKline

People needed

682

Starts

2008-07-01

Expected to finish

2010-11-16

Last updated by the study team

2017-12-07

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Rancho Mirage, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Hallandale, Florida, United States
• GSK Investigational Site — Hialeah, Florida, United States
• GSK Investigational Site — Paterson, New Jersey, United States
• GSK Investigational Site — Syracuse, New York, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Tulsa, Oklahoma, United States
• GSK Investigational Site — Memphis, Tennessee, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Bennington, Vermont, United States
• GSK Investigational Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — Ciudad de Buenos Aires, Buenos Aires, Argentina
• GSK Investigational Site — La Plata, Buenos Aires, Argentina
• GSK Investigational Site — Córdoba, Córdoba Province, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — Santa Fe, Argentina
• GSK Investigational Site — Kogarah, New South Wales, Australia
• GSK Investigational Site — Herston, Queensland, Australia
• GSK Investigational Site — Woodville, South Australia, Australia
• GSK Investigational Site — Ballarat, Victoria, Australia
• GSK Investigational Site — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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