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Sponsors and Collaborators: |
Clayton Sleep Insititute St. Louis University |
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Information provided by: | Clayton Sleep Insititute |
ClinicalTrials.gov Identifier: | NCT00706186 |
Eligible patients will undergo this open label initial safety and feasibility study investigating the use of 6 g/day sodium oxybate in mild AD. A total of 5 visits are included with this trial and total subject participation duration of 7-8 weeks. The screening phase will include an initial screening visit and a screening PSG night. After successful screening, subjects will complete a baseline PSG night and undergo a third PSG night to monitor initial safety and compliance with study drug at a dosage of 4.5 g/day of sodium oxybate. Thus the subject will undergo three consecutive nights of PSG in the sleep center. The patient will maintain a dosage of 4.5 g/day for a duration of 7 days leading to Treatment Visit 1. After successful assessment at Treatment Visit 1, the dosage will be increased to 6 g/day for the duration of the trial. At Treatment Visit 2 (day 21), the dosage will be increased to a dosage of 9 g/day, if tolerated by the patient. The remaining visit will occur at 6 weeks after baseline, with Treatment Visit 3 consisting of two consecutive nights of PSG. Participation will be complete after this visit. Phone follow-up will be made at one week post completion visits to assess any wash-out symptoms. Please refer to Figure for flow of the study design.
Condition | Intervention | Phase |
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Mild Alzheimer's Disease |
Drug: Sodium Oxybate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase IV Study Safety & Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients. |
Enrollment: | 4 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 50 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study inclusion:
Exclusion Criteria:
United States, Missouri | |
Clayton Sleep Institute | |
St. Louis, Missouri, United States, 63143 |
Study Director: | Eric Powell, PhD | Clayton Sleep Institute |
Responsible Party: | Clayton Sleep Institute ( Eric Powell, PhD ) |
Study ID Numbers: | ALD Xyrem |
Study First Received: | June 24, 2008 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00706186 |
Health Authority: | United States: Institutional Review Board |
Mild Alzheimer's Disease |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Benzocaine Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Sodium Oxybate Cognition Disorders Delirium |
Anesthetics, Intravenous Adjuvants, Anesthesia Anesthetics, General Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Depressants Anesthetics Tauopathies Central Nervous System Agents Pharmacologic Actions |