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

December 23, 2009 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

380

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Hall in Tirol, Austria, A-6060
        • GSK Investigational Site
      • Innsbruck, Austria, A-6020
        • GSK Investigational Site
      • Retz, Austria, A-2070
        • GSK Investigational Site
      • Vienna, Austria, A-1130
        • GSK Investigational Site
      • Vienna, Austria, A-1040
        • GSK Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • GSK Investigational Site
      • Sofia, Bulgaria, 1431
        • GSK Investigational Site
      • Sofia, Bulgaria, 1527
        • GSK Investigational Site
      • Sofia, Bulgaria, 1113
        • GSK Investigational Site
      • Varna, Bulgaria, 9010
        • GSK Investigational Site
  • Chile
    • Región Metro De Santiago
      • Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
        • GSK Investigational Site
      • Santiago, Región Metro De Santiago, Chile
        • GSK Investigational Site
    • Valparaíso
      • Valparaiso, Valparaíso, Chile, 2352499
        • GSK Investigational Site
  • Croatia
      • Split, Croatia, 21000
        • GSK Investigational Site
      • Zagreb, Croatia, 10000
        • GSK Investigational Site
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • GSK Investigational Site
      • Ostrava, Czech Republic, 702 00
        • GSK Investigational Site
      • Praha 5, Czech Republic, 150 18
        • GSK Investigational Site
      • Rychnov Nad Kneznou, Czech Republic, 516 01
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 115 21
        • GSK Investigational Site
      • Athens, Greece, 151 23
        • GSK Investigational Site
      • Melissia, Greece, 151 27
        • GSK Investigational Site
      • Thessaloniki, Greece, 57010
        • GSK Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 150-719
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • GSK Investigational Site
  • New Zealand
      • Auckland, New Zealand, 1309
        • GSK Investigational Site
      • Christchurch, New Zealand, 8002
        • GSK Investigational Site
  • Poland
      • Mosina, Poland, 62-050
        • GSK Investigational Site
      • Olsztyn, Poland, 10-082
        • GSK Investigational Site
      • Warszawa, Poland, 02-097
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 115522
        • GSK Investigational Site
      • Moscow, Russian Federation, 117049
        • GSK Investigational Site
      • St.-Petersburg, Russian Federation, 198103
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • GSK Investigational Site
      • Bratislava, Slovakia, 811 01
        • GSK Investigational Site
      • Bratislava, Slovakia, 811 07
        • GSK Investigational Site
      • Bratislava, Slovakia, 811 08
        • GSK Investigational Site
      • Kosice, Slovakia, 041 66
        • GSK Investigational Site
      • Rimavska Sobota, Slovakia, 979 12
        • GSK Investigational Site
  • South Africa
      • Oakdale, South Africa, 7530
        • GSK Investigational Site
      • Rosebank, South Africa, 2196
        • GSK Investigational Site
      • Somerset West, South Africa, 7130
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08025
        • GSK Investigational Site
      • Barcelona, Spain, 08003
        • GSK Investigational Site
      • Barcelona, Spain, 08014
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Sant Cugat Del Vallés/, Spain, 08190
        • GSK Investigational Site
      • Tarrasa, Barcelona, Spain, 08221
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in cognition and function after 24 weeks.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 23, 2005

Study Record Updates

Last Update Posted (Estimate)

December 24, 2009

Last Update Submitted That Met QC Criteria

December 23, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ3100603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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