A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00710684
First received: June 30, 2008
Last updated: March 15, 2012
Last verified: September 2011
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Purpose
The study is designed to investigate the safety and efficacy of SB-742457 when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Mild-to-moderate Alzheimer's Disease Alzheimer's Disease |
Drug: SB-742457 15mg Drug: SB-742457 35mg Drug: Placebo Drug: donepezil 5-10mg |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Study AZ3110866, a Fixed Dose Study of SB-742457 Versus Placebo When Added to Existing Donepezil Treatment 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in cognition and function after 12, 24, 36 and 48 weeks. Safety and tolerability. Pharmacokinetics and exploratory pharmacogenetics. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 684 |
| Study Start Date: | July 2008 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SB-742457
SB-742457
|
Drug: SB-742457 15mg
SB-742457 - 15mg added to existing donepezil treatment
Drug: SB-742457 35mg
SB-742457 - 35mg added to existing donepezil
Drug: donepezil 5-10mg
existing donepezil treatment
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo added to existing donepezil
Drug: donepezil 5-10mg
existing donepezil treatment
|
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects and their caregivers must provide informed consent prior to study entry.
- Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's disease with no evidence of disorders that are thought to be the cause of, or contributing to the severity of the subject's dementia and a documented history of at least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2 months.
- Subjects must have a regular caregiver who is willing to attend visits, oversee the subject's compliance with the study and report on the subject's status.
- Female subjects of child-bearing potential must agree to abstinence or an approved form of birth control.
- Subjects must have adequate blood pressure and laboratory values.
Exclusion Criteria:
- Subjects with a diagnosis of possible, probable or definite vascular dementia may not participate.
- Subjects with known hypersensitivity to sunlight or a history of seizures, previous exposure to SB-742457, taking agents for which there is a theoretical risk of interaction with SB-742457, or taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes may not participate.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710684
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| United States, Arizona | |
| GSK Investigational Site | |
| Litchfield Park, Arizona, United States, 85340 | |
| United States, California | |
| GSK Investigational Site | |
| Fresno, California, United States, 93720 | |
| GSK Investigational Site | |
| Rancho Mirage, California, United States, 92270 | |
| GSK Investigational Site | |
| San Francisco, California, United States, 94109 | |
| United States, Florida | |
| GSK Investigational Site | |
| Hallandale Beach, Florida, United States, 33009 | |
| GSK Investigational Site | |
| Hialeah, Florida, United States, 33016 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Manchester, New Jersey, United States, 08759 | |
| United States, New York | |
| GSK Investigational Site | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Winston-salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| GSK Investigational Site | |
| Austin, Texas, United States, 78757 | |
| United States, Vermont | |
| GSK Investigational Site | |
| Bennington, Vermont, United States, 05201 | |
| Argentina | |
| GSK Investigational Site | |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1022AAO | |
| GSK Investigational Site | |
| Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1405BCH | |
| GSK Investigational Site | |
| Ciudad de Buenos Aires, Buenos Aires, Argentina, C1431FWO | |
| GSK Investigational Site | |
| La Plata, Buenos Aires, Argentina, B1900AVG | |
| GSK Investigational Site | |
| Cordoba, Córdova, Argentina, 5000 | |
| GSK Investigational Site | |
| Buenos Aires, Argentina, 1425 | |
| GSK Investigational Site | |
| Santa Fe, Argentina, 3000 | |
| Australia, New South Wales | |
| GSK Investigational Site | |
| Kogarah, New South Wales, Australia, 2217 | |
| Australia, Queensland | |
| GSK Investigational Site | |
| Herston, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| GSK Investigational Site | |
| Woodville, South Australia, Australia, 5011 | |
| Australia, Victoria | |
| GSK Investigational Site | |
| Ballarat, Victoria, Australia, 3350 | |
| GSK Investigational Site | |
| Heidelberg West, Victoria, Australia, 3084 | |
| GSK Investigational Site | |
| KEW, Victoria, Australia, 3101 | |
| Australia, Western Australia | |
| GSK Investigational Site | |
| Nedlands, Western Australia, Australia, 6009 | |
| Canada, New Brunswick | |
| GSK Investigational Site | |
| Saint John, New Brunswick, Canada, E2L 3L6 | |
| Canada, Nova Scotia | |
| GSK Investigational Site | |
| Kentville, Nova Scotia, Canada, B4N 4K9 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Ottawa, Ontario, Canada, K1G 4G3 | |
| GSK Investigational Site | |
| Peterborough, Ontario, Canada, K9H 2P4 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M3B 2S7 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M6M 3Z5 | |
| Canada, Quebec | |
| GSK Investigational Site | |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| GSK Investigational Site | |
| Québec, Quebec, Canada, G1R 3X5 | |
| GSK Investigational Site | |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| GSK Investigational Site | |
| Sherbrooke, Quebec, Canada, J1J 3H5 | |
| Chile | |
| GSK Investigational Site | |
| Santiago, Región Metro de Santiago, Chile, 7510186 | |
| GSK Investigational Site | |
| Santiago, Región Metro de Santiago, Chile, 7560356 | |
| GSK Investigational Site | |
| Viña Del Mar, Valparaíso, Chile, 252-0997 | |
| GSK Investigational Site | |
| Santiago, Chile | |
| Czech Republic | |
| GSK Investigational Site | |
| Melnik, Czech Republic, 27601 | |
| GSK Investigational Site | |
| Olomouc, Czech Republic, 775 20 | |
| GSK Investigational Site | |
| Ostrava, Czech Republic, 702 00 | |
| GSK Investigational Site | |
| Pardubice, Czech Republic, 53203 | |
| GSK Investigational Site | |
| Plzen, Czech Republic, 301 00 | |
| GSK Investigational Site | |
| Praha 1, Czech Republic, 110 00 | |
| GSK Investigational Site | |
| Praha 10, Czech Republic, 10000 | |
| GSK Investigational Site | |
| Praha 4, Czech Republic, 14059 | |
| Germany | |
| GSK Investigational Site | |
| Ellwangen, Baden-wuerttemberg, Germany, 73479 | |
| GSK Investigational Site | |
| Stuttgart, Baden-wuerttemberg, Germany, 70176 | |
| GSK Investigational Site | |
| Tuebingen, Baden-wuerttemberg, Germany, 72076 | |
| GSK Investigational Site | |
| ULM, Baden-wuerttemberg, Germany, 89075 | |
| GSK Investigational Site | |
| Alzenau, Bayern, Germany, 63755 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 81675 | |
| GSK Investigational Site | |
| Regensburg, Bayern, Germany, 93053 | |
| GSK Investigational Site | |
| Unterhaching, Bayern, Germany, 82008 | |
| GSK Investigational Site | |
| Bad Homburg, Hessen, Germany, 61348 | |
| GSK Investigational Site | |
| Schwerin, Mecklenburg-vorpommern, Germany, 19053 | |
| GSK Investigational Site | |
| Achim, Niedersachsen, Germany, 28832 | |
| GSK Investigational Site | |
| Aachen, Nordrhein-westfalen, Germany, 52062 | |
| GSK Investigational Site | |
| Bad Honnef, Nordrhein-westfalen, Germany, 53604 | |
| GSK Investigational Site | |
| Bochum, Nordrhein-westfalen, Germany, 44869 | |
| GSK Investigational Site | |
| Dresden, Sachsen, Germany, 01309 | |
| GSK Investigational Site | |
| Dresden, Sachsen, Germany, 01097 | |
| GSK Investigational Site | |
| Jena, Thueringen, Germany, 07743 | |
| GSK Investigational Site | |
| Berlin, Germany, 13439 | |
| GSK Investigational Site | |
| Berlin, Germany, 12163 | |
| GSK Investigational Site | |
| Berlin, Germany, 10961 | |
| Italy | |
| GSK Investigational Site | |
| Chieti Scalo, Abruzzo, Italy, 66013 | |
| GSK Investigational Site | |
| Napoli, Campania, Italy, 80131 | |
| GSK Investigational Site | |
| San Felice A Cancello - Caserta, Campania, Italy, 81027 | |
| GSK Investigational Site | |
| Cassino (fr), Lazio, Italy, 03043 | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00148 | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00163 | |
| GSK Investigational Site | |
| Brescia, Lombardia, Italy, 25125 | |
| GSK Investigational Site | |
| Castellanza (va), Lombardia, Italy, 21053 | |
| GSK Investigational Site | |
| Milano, Lombardia, Italy, 20132 | |
| GSK Investigational Site | |
| Milano, Lombardia, Italy, 20122 | |
| GSK Investigational Site | |
| RHO, Lombardia, Italy, 20017 | |
| GSK Investigational Site | |
| Torino, Piemonte, Italy, 10126 | |
| GSK Investigational Site | |
| Lido Di Camaiore (lu), Toscana, Italy, 55043 | |
| GSK Investigational Site | |
| Pisa, Toscana, Italy, 56126 | |
| GSK Investigational Site | |
| Perugia, Umbria, Italy, 06156 | |
| GSK Investigational Site | |
| Valdagno (vi), Veneto, Italy, 36078 | |
| GSK Investigational Site | |
| Verona, Veneto, Italy, 37126 | |
| Spain | |
| GSK Investigational Site | |
| Baracaldo/vizcaya, Spain, 48903 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08014 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08003 | |
| GSK Investigational Site | |
| Barcelona, Spain, 08907 | |
| GSK Investigational Site | |
| Burgos, Spain, 09006 | |
| GSK Investigational Site | |
| Castellón, Spain, 12004 | |
| GSK Investigational Site | |
| Madrid, Spain, 28006 | |
| GSK Investigational Site | |
| Murcia, Spain, 30120 | |
| GSK Investigational Site | |
| Salamanca, Spain, 37007 | |
| GSK Investigational Site | |
| San Sebastián, Spain, 20014 | |
| GSK Investigational Site | |
| San Vicente Del Raspeig/alicante, Spain, 03690 | |
| GSK Investigational Site | |
| Valencia, Spain, 46010 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00710684 History of Changes |
| Other Study ID Numbers: | AZ3110866 |
| Study First Received: | June 30, 2008 |
| Last Updated: | March 15, 2012 |
| Health Authority: | United States: Food and Drug Administration Spain: Spanish Agency of Medicines Germany: Federal Institute for Drugs and Medical Devices Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Canada: Health Canada Italy: The Italian Medicines Agency Australia: Department of Health and Ageing Therapeutic Goods Administration Czech Republic: State Institute for Drug Control |
Keywords provided by GlaxoSmithKline:
|
Alzheimer's disease cognition SB-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 Donepezil |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013