SB-742457 And Donepezil In Alzheimer's Disease - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00348192

Purpose

The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's Disease. SB-742457 is a new treatment which is thought to increase 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	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Investigate the Effects of SB-742457, Donepezil and Placebo on Cognition in Subjects With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change in cognition and function after 24 weeks.

Secondary Outcome Measures:

Change in behavioral symptoms, activities of daily living and caregiver burden after 24 weeks Changes in all symptoms at 8 and 12 weeks Safety and tolerability PK (pharmacokinetic) profiling. Efficacy related to ApoE and HTR6 status

Estimated Enrollment:	200
Study Start Date:	May 2006

Eligibility

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

Criteria

Inclusion criteria:

Clinical diagnosis of probable mild-to-moderate Alzheimer's Disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24.
Subjects and their caregivers must provide informed consent prior to study entry.
Adequate blood pressure and laboratory values.

Exclusion criteria:

Females of child-bearing potential.
Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency.
Subjects taking medication for Alzheimers disease or centrally acting agents which might impact study outcomes.
Subjects taking agents for which there is a theoretical risk of interaction with SB-742457 or donepezil.
Subjects with conditions which might be exacerbated by exposure to donepezil.
Subjects with known hypersensitivity to sunlight or seizures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348192

Locations

Austria
GSK Investigational Site
Hall in Tirol, Austria, A-6060
GSK Investigational Site
Vienna, Austria, A-1130
GSK Investigational Site
Vienna, Austria, A-1220
Bulgaria
GSK Investigational Site
Varna, Bulgaria, 9010
GSK Investigational Site
Sofia, Bulgaria, 1431
GSK Investigational Site
Sofia, Bulgaria, 1113
Chile, Región Metro De Santiago
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7560356
GSK Investigational Site
Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
Chile, Valparaíso
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2352499
Estonia
GSK Investigational Site
Tartu, Estonia, 51014
GSK Investigational Site
Tallinn, Estonia, 10617
Germany, Baden-Wuerttemberg
GSK Investigational Site
Ostfildern, Baden-Wuerttemberg, Germany, 73760
Germany, Hessen
GSK Investigational Site
Huettenberg, Hessen, Germany, 35625
Germany, Niedersachsen
GSK Investigational Site
Achim, Niedersachsen, Germany, 28832
Germany, Nordrhein-Westfalen
GSK Investigational Site
Baesweiler, Nordrhein-Westfalen, Germany, 52499
GSK Investigational Site
Hattingen, Nordrhein-Westfalen, Germany, 45525
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 115552
GSK Investigational Site
St. Petersburg, Russian Federation, 197022
GSK Investigational Site
St.-Petersburg, Russian Federation, 198103
GSK Investigational Site
Moscow, Russian Federation, 117049
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 831 03
GSK Investigational Site
Bratislava, Slovakia, 826 06
GSK Investigational Site
Bratislava, Slovakia, 811 01
United Kingdom
GSK Investigational Site
West of Scotland Science Park, Glasgow, United Kingdom, G20 0XA
GSK Investigational Site
Bradford, United Kingdom, BD7 1HR
GSK Investigational Site
Swindon, United Kingdom, SN1 4HZ

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	AZ3106242
Study First Received:	June 30, 2006
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00348192 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by GlaxoSmithKline:

Alzheimer's Disease
cognition global functioning
symptomatic
SB-742457

Study placed in the following topic categories:

Nootropic Agents
Neurotransmitter Agents
Alzheimer Disease
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Cholinergic Agents

Cognition Disorders
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Dementia
Delirium

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases

Neurodegenerative Diseases
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Donepezil
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009