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SB-742457 And Donepezil In Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00348192
First received: June 30, 2006
Last updated: May 28, 2009
Last verified: May 2009
History of Changes

June 30, 2006
May 28, 2009
May 2006
Not Provided
Change in cognition and function after 24 weeks.
Same as current
Complete list of historical versions of study NCT00348192 on ClinicalTrials.gov 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.
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: SB-742457
  • Drug: donepezil
    Other Names:
    • SB-742457
    • donepezil
Not Provided
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. Epub 2010 Sep 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Not Provided
Not Provided

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.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Bulgaria,   Chile,   Estonia,   Germany,   Russian Federation,   Slovakia,   United Kingdom
 
NCT00348192
AZ3106242
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

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