Status:
COMPLETED
Study of SB-742457 or Donepezil Versus Placebo in Subjects With 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 efficacy, safety and tolerability of SB-742457 versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an experimental treatment whi...
Eligibility Criteria
Inclusion
- 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 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
July 4 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2010
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT00708552
Start Date
July 4 2008
End Date
March 9 2010
Last Update
July 27 2018
Active Locations (72)
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1
GSK Investigational Site
Shumen, Bulgaria, 9700
2
GSK Investigational Site
Sofia, Bulgaria, 1113
3
GSK Investigational Site
Sofia, Bulgaria, 1431
4
GSK Investigational Site
Varna, Bulgaria, 9010