SPX, Irvine CA: Cortex Pharmaceuticals has announced that the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense is sponsoring a new CX717 study. Results from this study could help confirm and extend the positive findings with CX717 from the recently completed sleep deprivation study.
Rationale for the Study: The new study will evaluate the cognitive performance and objective alerting effects of CX717 utilizing a simulated night shift work paradigm.
Volunteers will undergo four nights of simulated shift work during which they will be “on shift” (high work load) from 11:00 P.M. to 7:00 A.M.
The volunteers will also be restricted to only four hours of recovery sleep on each of the four study days. Three different doses of CX717 will be compared to placebo in randomized, double-blind, parallel-group design.
The study medication will be given daily prior to the simulated night shift activities. Outcome measures will include the maintenance of wakefulness test, cognitive performance tests, and polysomnography during the recovery sleep period.
According to Dr. Roger G. Stoll, Chairman, President and CEO of Cortex, “Cortex will supply CX717 and matching placebos for the study. DARPA will fund a military research organization to conduct the study.
The first volunteers are expected to be enrolled this summer and we expect that the study should be concluded near the end of the year.
Positive results from this study could move CX717 closer toward a marketable indication, namely to improve wakefulness in patients with Excessive Daytime Sleepiness (EDS), while at the same time provide the military with a simulated situation that more closely approximates the adverse sleep conditions often faced by soldiers during military operations.”
Cortex announced on May 3, 2005 that CX717, when compared to placebo, increased wakefulness in a dose-related manner and improved performance in healthy male subjects that became impaired during 27 hours without sleep.
The study was performed in the United Kingdom at the Academic Clinic for Disorders of Sleep and Wakefulness within the Human Psychopharmacology Research Unit at the Medical Research Centre, School of Biomedical and Molecular Sciences, University of Surrey by Dr. Julia Boyle, Acting Director of the Research Unit and Professor Anthony N. Nicholson, Medical Director and Visiting Professor of Aviation Medicine, King's College London.
About Excessive Daytime Sleepiness (EDS) and Shift Work
There are direct benefits to the broader civilian population from this AMPAKINE study in EDS. The National Commission on Sleep Disorders estimates that 40 million Americans are either chronically or intermittently affected with various sleep disorders.
In addition to the tremendous personal pain and suffering they inflict, sleep disorders are a tremendous drain on the productivity and safety of our country: falling asleep at the wheel is one of the most costly and devastating problems on American highways; accidents in the workplace due to sleep deprivation are commonplace and damaging to industry; the annual direct cost to society is over $15 billion.
AMPAKINE products may also be useful in the treatment of narcolepsy, jet lag and rotating shift workers in the workplace.
