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

This study is not yet open for participant recruitment.

Verified by GlaxoSmithKline, July 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00708552

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 II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Donepezil E 2020

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study AZ3110865, a Study Comparing SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-Moderate Alzheimer's Disease

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Assessment of cognition and global function after 24 weeks treatment

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.

Estimated Enrollment:	576
Study Start Date:	July 2008

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708552

Show 61 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Study ID Numbers:	AZ3110865
Study First Received:	June 30, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00708552
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Bulgaria: Bulgarian Drug Agency; Czech Republic: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Health and Social Development of the Russian Federation; Estonia: The State Agency of Medicine; Greece: Ministry of Health and Welfare; South Africa: Medicines Control Council; Chile: Instituto de Salud Publica de Chile; Korea: Food and Drug Administration; Mexico: Ethics Committee

Keywords provided by GlaxoSmithKline:

Alzheimer's disease
Cognition
SB-742457

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nootropic Agents
Cholinesterase Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Tauopathies
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009