Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 3 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.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00708552
First received: June 30, 2008
Last updated: May 31, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
comparator
Experimental: SB-742457 - 35mg
SB-742457 - 35mg
Drug: SB-742457
investigational drug
Active Comparator: Donepezil Drug: Donepezil
comparator

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00708552

  Show 57 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00708552     History of Changes
Other Study ID Numbers: AZ3110865
Study First Received: June 30, 2008
Last Updated: May 31, 2012
Health Authority: Bulgaria: Bulgarian Drug Agency
Mexico: Ethics Committee
Chile: Instituto de Salud Pública de Chile
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Greece: Ministry of Health and Welfare
Korea: Food and Drug Administration
South Africa: Medicines Control Council
Estonia: The State Agency of Medicine
Russia: Ministry of Health of the Russian Federation
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control

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

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014