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A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00710684
First received: June 30, 2008
Last updated: March 15, 2012
Last verified: September 2011

June 30, 2008
March 15, 2012
July 2008
May 2010   (final data collection date for primary outcome measure)
Change in cognition and function after 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in cognition and function after 24 weeks.
Complete list of historical versions of study NCT00710684 on ClinicalTrials.gov Archive Site
Change in cognition and function after 12, 24, 36 and 48 weeks. Safety and tolerability. Pharmacokinetics and exploratory pharmacogenetics. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Change in cognition and function after 12 and 24 weeks. Safety and tolerability. Pharmacokinetics and exploratory pharmacogenetics.
Not Provided
Not Provided
 
A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
Study AZ3110866, a Fixed Dose Study of SB-742457 Versus Placebo When Added to Existing Donepezil Treatment in Subjects With Mild-to-moderate Alzheimer's Disease

The study is designed to investigate the safety and efficacy of SB-742457 when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Mild-to-moderate Alzheimer's Disease
  • Alzheimer's Disease
  • Drug: SB-742457 15mg
    SB-742457 - 15mg added to existing donepezil treatment
  • Drug: SB-742457 35mg
    SB-742457 - 35mg added to existing donepezil
  • Drug: Placebo
    Placebo added to existing donepezil
  • Drug: donepezil 5-10mg
    existing donepezil treatment
  • Experimental: SB-742457
    SB-742457
    Interventions:
    • Drug: SB-742457 15mg
    • Drug: SB-742457 35mg
    • Drug: donepezil 5-10mg
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: donepezil 5-10mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
684
August 2011
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects and their caregivers must provide informed consent prior to study entry.
  • Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's disease with no evidence of disorders that are thought to be the cause of, or contributing to the severity of the subject's dementia and a documented history of at least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2 months.
  • 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 abstinence or an approved form of birth control.
  • Subjects must have adequate blood pressure and laboratory values.

Exclusion Criteria:

  • Subjects with a diagnosis of possible, probable or definite vascular dementia may not participate.
  • Subjects with known hypersensitivity to sunlight or a history of seizures, 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.
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Canada,   Chile,   Czech Republic,   Germany,   Italy,   Spain
 
NCT00710684
AZ3110866
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

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