SB-742457 And Donepezil In Alzheimer's Disease

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348192
• Other study ID #: AZ3106242
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2006
• Last updated: May 28, 2009
• Start date: May 2006

Study information

• Verified date: May 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• SB-742457

• donepezil

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Hall in Tirol
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Varna
Chile	GSK Investigational Site	Providencia / Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Santiago	Región Metro De Santiago
Chile	GSK Investigational Site	Valparaiso	Valparaíso
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Germany	GSK Investigational Site	Achim	Niedersachsen
Germany	GSK Investigational Site	Baesweiler	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hattingen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Huettenberg	Hessen
Germany	GSK Investigational Site	Ostfildern	Baden-Wuerttemberg
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St.-Petersburg
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
United Kingdom	GSK Investigational Site	Bradford
United Kingdom	GSK Investigational Site	Swindon
United Kingdom	GSK Investigational Site	West of Scotland Science Park, Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  Bulgaria,  Chile,  Estonia,  Germany,  Russian Federation,  Slovakia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognition and function after 24 weeks.
Secondary	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