Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease
NCT ID: NCT00708552
Last Updated: 2018-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
576 participants
INTERVENTIONAL
2008-07-04
2010-03-09
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
Study Groups
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SB-742457 - 15mg
SB-742457 - 15mg
SB-742457
investigational drug
Placebo
Placebo
comparator
SB-742457 - 35mg
SB-742457 - 35mg
SB-742457
investigational drug
Donepezil
Donepezil
comparator
Interventions
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SB-742457
investigational drug
Donepezil
comparator
Placebo
comparator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
85 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Shumen, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Varna, , Bulgaria
GSK Investigational Site
Viña del Mar, Región de Valparaíso, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Santiago, , Chile
GSK Investigational Site
Brno, , Czechia
GSK Investigational Site
Olomouc, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tallinn, , Estonia
GSK Investigational Site
Tartu, , Estonia
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, Germany
GSK Investigational Site
Tübingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Neuburg an der Donau, Bavaria, Germany
GSK Investigational Site
Nuremberg, Bavaria, Germany
GSK Investigational Site
Unterhaching, Bavaria, Germany
GSK Investigational Site
Bad Homburg, Hesse, Germany
GSK Investigational Site
Erbach im Odenwald, Hesse, Germany
GSK Investigational Site
Hüttenberg, Hesse, Germany
GSK Investigational Site
Achim, Lower Saxony, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, Germany
GSK Investigational Site
Bochum, North Rhine-Westphalia, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, Germany
GSK Investigational Site
Duisburg, North Rhine-Westphalia, Germany
GSK Investigational Site
Düren, North Rhine-Westphalia, Germany
GSK Investigational Site
Hattingen, North Rhine-Westphalia, Germany
GSK Investigational Site
Siegen, North Rhine-Westphalia, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Leipzig, Saxony, Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Melíssia, , Greece
GSK Investigational Site
Thessaloniki, , Greece
GSK Investigational Site
Aguascalientes, Ags, Aguascalientes, Mexico
GSK Investigational Site
Tijuana, Baja California Norte, Mexico
GSK Investigational Site
Saltillo, Coahuila, Mexico
GSK Investigational Site
Monterrey, Nuevo León, Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Bydgoszcz, , Poland
GSK Investigational Site
Bydgoszcz, , Poland
GSK Investigational Site
Mosina, , Poland
GSK Investigational Site
Poznan, , Poland
GSK Investigational Site
Sopot, , Poland
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Durban, , South Africa
GSK Investigational Site
Loeventstein, , South Africa
GSK Investigational Site
Oakdale, , South Africa
GSK Investigational Site
Pretoria, , South Africa
GSK Investigational Site
Rosebank, , South Africa
GSK Investigational Site
Sunninghill, , South Africa
GSK Investigational Site
Busan, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
Countries
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References
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Maher-Edwards G, Watson C, Ascher J, Barnett C, Boswell D, Davies J, Fernandez M, Kurz A, Zanetti O, Safirstein B, Schronen JP, Zvartau-Hind M, Gold M. Two randomized controlled trials of SB742457 in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2015 May 7;1(1):23-36. doi: 10.1016/j.trci.2015.04.001. eCollection 2015 Jun.
Other Identifiers
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AZ3110865
Identifier Type: -
Identifier Source: org_study_id
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