Trial record 3 of 5 for:
SB742457
Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00708552
First received: June 30, 2008
Last updated: May 31, 2012
Last verified: February 2012
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Purpose
The study is designed to investigate the efficacy, safety and tolerability of SB-742457 versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an experimental treatment which increases 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 Drug: Donepezil Drug: Placebo |
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 AZ3110865, a Study Comparing SB-742457 or Donepezil Versus Placebo 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:
- Assessment of cognition and global function after 24 weeks treatment [ Time Frame: 24 weeks ]
Secondary Outcome Measures:
- Assessment of cognition and global function after 12 and 24 weeks treatment. Activities of daily living, assessment of depressive symptoms. Safety and tolerability. Pharmacokinetics and exploratory pharmacogenetics. [ Time Frame: 24 weeks ]
| Enrollment: | 576 |
| Study Start Date: | July 2008 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SB-742457 - 15mg
SB-742457 - 15mg
|
Drug: SB-742457
investigational drug
|
| Placebo Comparator: Placebo |
Drug: Placebo
comparator
|
|
Experimental: SB-742457 - 35mg
SB-742457 - 35mg
|
Drug: SB-742457
investigational drug
|
| Active Comparator: Donepezil |
Drug: Donepezil
comparator
|
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 a documented 6-month history of AD symptoms
- 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 pregnancy testing and approved form of birth control.
Exclusion criteria:
- Diagnosis of possible, probable or definite vascular dementia.
- History/evidence of any other CNS disorder that could be interpreted as a cause of dementia
- History of known or suspected seizures, loss of consciousness or significant head trauma
- Subjects with ECG, blood pressure and laboratory values outside of protocol criteria are excluded.
- Subjects with known photosensitivity
- Subjects with a history of 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: NCT00708552
Show 57 Study Locations
Show 57 Study LocationsSponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00708552 History of Changes |
| Other Study ID Numbers: | AZ3110865 |
| Study First Received: | June 30, 2008 |
| Last Updated: | May 31, 2012 |
| Health Authority: | Bulgaria: Bulgarian Drug Agency Mexico: Ethics Committee Chile: Instituto de Salud Publica de Chile Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Greece: Ministry of Health and Welfare Korea: Food and Drug Administration South Africa: Medicines Control Council Estonia: The State Agency of Medicine Russia: Ministry of Health of the Russian Federation Germany: Federal Institute for Drugs and Medical Devices 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 22, 2013