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Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00708552
First Posted: July 2, 2008
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
June 30, 2008
July 2, 2008
October 12, 2017
July 2008
March 2010   (Final data collection date for primary outcome measure)
Assessment of cognition and global function after 24 weeks treatment [ Time Frame: 24 weeks ]
Assessment of cognition and global function after 24 weeks treatment
Complete list of historical versions of study NCT00708552 on ClinicalTrials.gov Archive Site
Assessment of cognition and global function after 12 and 24 weeks treatment. Activities of daily living, assessment of depressive symptoms. Safety and tolerability. Pharmacokinetics and exploratory pharmacogenetics. [ Time Frame: 24 weeks ]
Assessment of cognition and global function after 12 and 24 weeks treatment. Activities of daily living, assessment of depressive symptoms. Safety and tolerability. Pharmacokinetics and exploratory pharmacogenetics.
Not Provided
Not Provided
 
Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease
Study AZ3110865, a Study Comparing SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease
The study is designed to investigate the efficacy, safety and tolerability of SB-742457 versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an experimental treatment which increases 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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: SB-742457
    investigational drug
  • Drug: Donepezil
    comparator
  • Drug: Placebo
    comparator
  • Experimental: SB-742457 - 15mg
    SB-742457 - 15mg
    Intervention: Drug: SB-742457
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: SB-742457 - 35mg
    SB-742457 - 35mg
    Intervention: Drug: SB-742457
  • Active Comparator: Donepezil
    Intervention: Drug: Donepezil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
576
March 2010
March 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 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:

  • Diagnosis of possible, probable or definite vascular dementia.
  • 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.
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Chile,   Czech Republic,   Estonia,   Germany,   Greece,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   South Africa
 
 
NCT00708552
AZ3110865
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2017

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