Status:
COMPLETED
A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2010
Estimated Enrollment :
682 Patients enrolled
Trial Details
Trial ID
NCT00710684
Start Date
July 1 2008
End Date
November 16 2010
Last Update
December 7 2017
Active Locations (102)
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1
GSK Investigational Site
Litchfield Park, Arizona, United States, 85340
2
GSK Investigational Site
Fresno, California, United States, 93720
3
GSK Investigational Site
Rancho Mirage, California, United States, 92270
4
GSK Investigational Site
San Francisco, California, United States, 94109