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

GlaxoSmithKline1 site in 1 country200 target enrollmentMay 2006

ConditionsAlzheimer's Disease

DrugsSB-742457 donepezil

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Alzheimer's Disease
Sponsor: GlaxoSmithKline
Enrollment: 200
Locations: 1
Primary Endpoint: Change in cognition and function after 24 weeks.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

TBD

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Change in cognition and function after 24 weeks.

Secondary Outcomes

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