Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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SB-742457
donepezil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects and their caregivers must provide informed consent prior to study entry.
* Adequate blood pressure and laboratory values.
Exclusion Criteria
* 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.
50 Years
85 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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GSK
Principal Investigators
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GSK Clinical Trials, MD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Hall in Tirol, , Austria
GSK Investigational Site
Vienna, , Austria
GSK Investigational Site
Vienna, , Austria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Varna, , Bulgaria
GSK Investigational Site
Valparaíso, Región de Valparaíso, Chile
GSK Investigational Site
Providencia / Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tartu, , Estonia
GSK Investigational Site
Ostfildern, Baden-Wurttemberg, Germany
GSK Investigational Site
Hüttenberg, Hesse, Germany
GSK Investigational Site
Achim, Lower Saxony, Germany
GSK Investigational Site
Baesweiler, North Rhine-Westphalia, Germany
GSK Investigational Site
Hattingen, North Rhine-Westphalia, Germany
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Bratislava, , Slovakia
GSK Investigational Site
Bratislava, , Slovakia
GSK Investigational Site
Bratislava, , Slovakia
GSK Investigational Site
Bradford, , United Kingdom
GSK Investigational Site
Swindon, , United Kingdom
GSK Investigational Site
West of Scotland Science Park, Glasgow, , United Kingdom
Countries
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References
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Maher-Edwards G, Dixon R, Hunter J, Gold M, Hopton G, Jacobs G, Hunter J, Williams P. SB-742457 and donepezil in Alzheimer disease: a randomized, placebo-controlled study. Int J Geriatr Psychiatry. 2011 May;26(5):536-44. doi: 10.1002/gps.2562. Epub 2010 Sep 24.
Other Identifiers
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AZ3106242
Identifier Type: -
Identifier Source: org_study_id
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