Trial record 5 of 5 for:    SB742457

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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00224497
First received: September 21, 2005
Last updated: December 23, 2009
Last verified: December 2009
  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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in cognition and function after 24 weeks.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 380
Study Start Date: September 2005
Intervention Details:
    Drug: SB-742457
    Other Name: SB-742457
  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224497

  Hide Study Locations
Locations
Austria
GSK Investigational Site
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
Bulgaria
GSK Investigational Site
Plovdiv, Bulgaria, 4000
GSK Investigational Site
Sofia, Bulgaria, 1113
GSK Investigational Site
Sofia, Bulgaria, 1527
GSK Investigational Site
Sofia, Bulgaria, 1431
GSK Investigational Site
Varna, Bulgaria, 9010
Chile
GSK Investigational Site
Providencia / Santiago, Región Metro De Santiago, Chile, 7500710
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2352499
Croatia
GSK Investigational Site
Split, Croatia, 21000
GSK Investigational Site
Zagreb, Croatia, 10000
Czech Republic
GSK Investigational Site
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
Greece
GSK Investigational Site
Athens, Greece, 115 21
GSK Investigational Site
Athens, Greece, 151 23
GSK Investigational Site
Melissia, Greece, 151 27
GSK Investigational Site
Thessaloniki, Greece, 57010
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Seoul, Korea, Republic of, 150-719
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1309
GSK Investigational Site
Christchurch, New Zealand, 8002
Poland
GSK Investigational Site
Mosina, Poland, 62-050
GSK Investigational Site
Olsztyn, Poland, 10-082
GSK Investigational Site
Warszawa, Poland, 02-097
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 117049
GSK Investigational Site
Moscow, Russian Federation, 115522
GSK Investigational Site
St.-Petersburg, Russian Federation, 198103
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 811 07
GSK Investigational Site
Bratislava, Slovakia, 826 06
GSK Investigational Site
Bratislava, Slovakia, 811 08
GSK Investigational Site
Bratislava, Slovakia, 811 01
GSK Investigational Site
Kosice, Slovakia, 041 66
GSK Investigational Site
Rimavska Sobota, Slovakia, 979 12
South Africa
GSK Investigational Site
Oakdale, South Africa, 7530
GSK Investigational Site
Rosebank, South Africa, 2196
GSK Investigational Site
Somerset West, South Africa, 7130
Spain
GSK Investigational Site
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00224497     History of Changes
Other Study ID Numbers: AZ3100603
Study First Received: September 21, 2005
Last Updated: December 23, 2009
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by GlaxoSmithKline:
Alzheimer's disease
cognition global functioning
symptomatic
B-742457

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014