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

• Status: Completed
• Trial end date: 2010-11-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Donepezil

Criteria

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.