A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00710684
First received: June 30, 2008
Last updated: March 15, 2012
Last verified: September 2011
  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:


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
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: NCT00710684

  Hide Study Locations
Locations
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 September 30, 2014