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:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00224497
First received: September 21, 2005
Last updated: December 23, 2009
Last verified: December 2009
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224497
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Hide Study LocationsLocations
| 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, 826 06 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 811 07 | |
| 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 Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013