Trial record 5 of 1041 for:
"Alzheimer Disease"
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
Show 100 Study Locations
Show 100 Study LocationsSponsors 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