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Trial record 4 of 5 for:    SB742457

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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: June 30, 2008
Last updated: March 21, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Alzheimer's Disease Drug: SB-742457 Drug: Donepezil Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study AZ3110865, a Study Comparing SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Assessment of cognition and global function after 24 weeks treatment [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 576
Study Start Date: July 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB-742457 - 15mg
SB-742457 - 15mg
Drug: SB-742457
investigational drug
Placebo Comparator: Placebo Drug: Placebo
Experimental: SB-742457 - 35mg
SB-742457 - 35mg
Drug: SB-742457
investigational drug
Active Comparator: Donepezil Drug: Donepezil


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00708552

  Show 72 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00708552     History of Changes
Other Study ID Numbers: AZ3110865
Study First Received: June 30, 2008
Last Updated: March 21, 2017

Keywords provided by GlaxoSmithKline:
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents processed this record on September 19, 2017