Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
Annual rept. 1 Sep 2010-31 Aug 2011
NORTHERN CALIFORNIA INST FOR RESEARCH AND EDUCATION SAN FRANCISCO
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During Year 1, progress was made in preparation for the initiation of subject enrollment. The study protocol has been finalized and a comprehensive assessment battery incorporating neurocognitive, objective alertness, and subjective symptom assessments has been assembled and finalized. The testing battery was selected on the basis of sensitivity to sleep-inducing agents and military relevance. Study equipment and supplies have been purchased. Scientific and human use approvals have been solicited. Study documentation has been submitted to the appropriate Institutional Review Boards for approval, and an Investigational New Drug application IND has been filed with the Food and Drug Administration. An IND number has been assigned which will allow for interstate shipment of study drug. In accordance with relevant federal regulations, the study has been registered with clinicaltrials.gov. Key study personnel have been hired and trained in preparation for upcoming enrollment. As a result of the progress made during Year 1, subject recruitment and enrollment will begin during the early months of Year 2.
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