Status:
COMPLETED
SB-742457 And Donepezil In Alzheimer's Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's Disease. SB-742457 is a new treatment which is thought...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Clinical diagnosis of probable mild-to-moderate Alzheimer's Disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24.
- Subjects and their caregivers must provide informed consent prior to study entry.
- Adequate blood pressure and laboratory values.
- Exclusion criteria:
- Females of child-bearing potential.
- Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency.
- Subjects taking medication for Alzheimers disease or centrally acting agents which might impact study outcomes.
- Subjects taking agents for which there is a theoretical risk of interaction with SB-742457 or donepezil.
- Subjects with conditions which might be exacerbated by exposure to donepezil.
- Subjects with known hypersensitivity to sunlight or seizures.
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00348192
Start Date
May 1 2006
Last Update
June 2 2009
Active Locations (26)
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1
GSK Investigational Site
Hall in Tirol, Austria, A-6060
2
GSK Investigational Site
Vienna, Austria, A-1130
3
GSK Investigational Site
Vienna, Austria, A-1220
4
GSK Investigational Site
Sofia, Bulgaria, 1113