A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

A Phase IIa/b Double-blind, Randomised, Placebo-controlled, Linear Trend Design Dose-ranging Study to Investigate the Effects of 24 Weeks of Monotherapy With SB-742457 on Cognition in Subjects With Mild to Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224497
• Other study ID #: AZ3100603
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2005
• Last updated: December 23, 2009
• Start date: September 2005

Study information

• Verified date: December 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: 380
• 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 Alzheimer's 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.

• Subjects with known hypersensitivity to sunlight or seizures.

Study Design

Allocation: Randomized, Endpoint Classification: 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

Locations

Country	Name	City	State
Austria	GSK Investigational Site	Hall in Tirol
Austria	GSK Investigational Site	Innsbruck
Austria	GSK Investigational Site	Retz
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Sofia
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
Croatia	GSK Investigational Site	Split
Croatia	GSK Investigational Site	Zagreb
Czech Republic	GSK Investigational Site	Olomouc
Czech Republic	GSK Investigational Site	Ostrava
Czech Republic	GSK Investigational Site	Praha 5
Czech Republic	GSK Investigational Site	Rychnov Nad Kneznou
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Melissia
Greece	GSK Investigational Site	Thessaloniki
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Christchurch
Poland	GSK Investigational Site	Mosina
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Warszawa
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	St.-Petersburg
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Kosice
Slovakia	GSK Investigational Site	Rimavska Sobota
South Africa	GSK Investigational Site	Oakdale
South Africa	GSK Investigational Site	Rosebank
South Africa	GSK Investigational Site	Somerset West
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Sant Cugat Del Vallés/
Spain	GSK Investigational Site	Tarrasa, Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Austria,  Bulgaria,  Chile,  Croatia,  Czech Republic,  Greece,  Korea, Republic of,  New Zealand,  Poland,  Russian Federation,  Slovakia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognition and function after 24 weeks.
Secondary	Change in behavioural symptoms, activities of daily living and caregiver burden after 24 weeks. Changes in all symptoms at 8 and 12 weeks. Safety and tolerability. PK and dose response profiling. Efficacy related to ApoE status.