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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00675090 |
This is a safety and tolerability study to investigate the effect of GSK239512 on mild to moderate Alzheimers disease patients. The dose of GSK239512 will be titrated to reach the most well tolerated dose in the patients.
Condition | Intervention | Phase |
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Mild to Moderate Alzheimers Disease |
Drug: GSK239512 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Single Blind, Placebo-Controlled, Randomised Study in Mild to Moderate Alzheimer's Disease Patients to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK239512, a Selective Histamine H3 Receptor Antagonist |
Estimated Enrollment: | 36 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Australia, New South Wales | |
GSK Investigational Site | Active, not recruiting |
Randwick, New South Wales, Australia, 2031 | |
Australia, Victoria | |
GSK Investigational Site | Active, not recruiting |
Heidelberg Heights, Victoria, Australia, 3084 | |
Czech Republic | |
GSK Investigational Site | Recruiting |
Prague 10, Czech Republic, 10100 | |
Korea, Republic of | |
GSK Investigational Site | Recruiting |
Seoul, Korea, Republic of, 138-736 | |
GSK Investigational Site | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
United Kingdom | |
GSK Investigational Site | Completed |
Southall, United Kingdom, UB1 3HW | |
GSK Investigational Site | Recruiting |
London, United Kingdom, SE1 1YR | |
GSK Investigational Site | Recruiting |
Cambridgeshire, United Kingdom, CB2 2QQ |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | H3B109689 |
Study First Received: | April 24, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00675090 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: State Institute for Drug Control; South Korea: Korea Food and Drug Administration (KFDA); Australia: Department of Health and Ageing Therapeutic Goods Administration |
Alzheimers Disease |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Histamine phosphate Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Histamine Delirium |
Nervous System Diseases Tauopathies |