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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.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: June 30, 2008
Last updated: March 15, 2012
Last verified: September 2011
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.

Condition Intervention Phase
Mild-to-moderate Alzheimer's Disease Alzheimer's Disease Drug: SB-742457 15mg Drug: SB-742457 35mg Drug: Placebo Drug: donepezil 5-10mg Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in cognition and function after 24 weeks. [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Change in cognition and function after 12, 24, 36 and 48 weeks. Safety and tolerability. Pharmacokinetics and exploratory pharmacogenetics. [ Time Frame: 48 weeks ]

Enrollment: 684
Study Start Date: July 2008
Study Completion Date: August 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB-742457
Drug: SB-742457 15mg
SB-742457 - 15mg added to existing donepezil treatment
Drug: SB-742457 35mg
SB-742457 - 35mg added to existing donepezil
Drug: donepezil 5-10mg
existing donepezil treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo added to existing donepezil
Drug: donepezil 5-10mg
existing donepezil treatment


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 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.
  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: NCT00710684

  Show 100 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00710684     History of Changes
Other Study ID Numbers: AZ3110866
Study First Received: June 30, 2008
Last Updated: March 15, 2012

Keywords provided by GlaxoSmithKline:
Alzheimer's disease cognition SB-742457

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 21, 2017