A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease
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| ClinicalTrials.gov Identifier: NCT00224497 |
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Recruitment Status :
Completed
First Posted : September 23, 2005
Last Update Posted : December 24, 2009
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Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: SB-742457 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 380 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| 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 |
| Study Start Date : | September 2005 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
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.
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| Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224497
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-1040 | |
| GSK Investigational Site | |
| Vienna, Austria, A-1130 | |
| Bulgaria | |
| GSK Investigational Site | |
| Plovdiv, Bulgaria, 4000 | |
| GSK Investigational Site | |
| Sofia, Bulgaria, 1113 | |
| GSK Investigational Site | |
| Sofia, Bulgaria, 1431 | |
| GSK Investigational Site | |
| Sofia, Bulgaria, 1527 | |
| 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, 115522 | |
| GSK Investigational Site | |
| Moscow, Russian Federation, 117049 | |
| GSK Investigational Site | |
| St.-Petersburg, Russian Federation, 198103 | |
| Slovakia | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 811 01 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 811 07 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 811 08 | |
| GSK Investigational Site | |
| Bratislava, Slovakia, 826 06 | |
| 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, 08003 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08014 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08025 | |
| 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 |
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00224497 |
| Other Study ID Numbers: |
AZ3100603 |
| First Posted: | September 23, 2005 Key Record Dates |
| Last Update Posted: | December 24, 2009 |
| Last Verified: | December 2009 |
Keywords provided by GlaxoSmithKline:
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Alzheimer's disease cognition global functioning symptomatic B-742457 |
Additional relevant MeSH terms:
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |