SB-742457 And Donepezil In Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00348192
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : June 2, 2009
Information provided by:

June 30, 2006
July 4, 2006
June 2, 2009
May 2006
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Change in cognition and function after 24 weeks.
Same as current
Complete list of historical versions of study NCT00348192 on Archive Site
Change in behavioral symptoms, activities of daily living and caregiver burden after 24 weeks Changes in all symptoms at 8 and 12 weeks Safety and tolerability PK (pharmacokinetic) profiling. Efficacy related to ApoE and HTR6 status
  • Change in behavioural symptoms, activities of daily living and caregiver burden after 24 weeks.
  • Changes in all symptoms at 8 and 12 weeks
  • Safety and tolerability
  • PK (pharmacokinetic) profiling
  • Efficacy related to ApoE and HTR6 status.
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SB-742457 And Donepezil In Alzheimer's Disease
A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Effects of SB-742457, Donepezil and Placebo on Cognition in Subjects With Mild to Moderate Alzheimer's Disease
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 to increase the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's Disease.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: SB-742457
  • Drug: donepezil
    Other Name: SB-742457
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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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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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.
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Bulgaria,   Chile,   Estonia,   Germany,   Russian Federation,   Slovakia,   United Kingdom
Argentina,   Hungary
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Study Director, GSK
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP