Ampakine (CX717) effects on performance and alertness during simulated night shift work.

INTRODUCTION: Round-the-clock operations in both military and civilian sectors have increased the need for alertness- and performance-maintaining strategies. The potential performance and objective alertness-enhancing effects of CX717 (a novel cognitive enhancer currently being tested in Phase II clinical trials) were evaluated using a simulated night shift work paradigm.
METHODS: In this randomized, double-blind, placebo-controlled, parallel groups design, 48 volunteers underwent 4 consecutive nights of simulated shift work. Each "shift" consisted of the following: at approximately 2145 (just prior to the start of each simulated night shift), volunteers ingested a single oral dose of CX717 200 mg, CX717 400 mg, CX717 1000 mg, or placebo (N = 12 per drug dosage). Performance, alertness, mood, and symptoms were then assessed from 2300 to 0700, followed by a polysomnographically monitored daytime sleep period from 0800 to 1200.
RESULTS: Performance and alertness significantly degraded across the simulated night shifts (P < 0.05). None of the dosages of CX717 reversed these effects (P > 0.05). CX717 exerted some effects on daytime sleep, most notably reduction of slow-wave sleep time (P < 0.05). CX71 7 caused very few side effects and none of those were serious or unexpected. DISCUSSION AND
CONCLUSIONS: At the doses tested, CX717 was not effective for reversing performance and alertness deficits associated with night shift work. Further work evaluating higher doses of CX717 may be warranted, as are studies in which CX717 effects are explored under other conditions (e.g., Alzheimer's dementia, attention deficit disorder).

RCT Entities:   Population Interventions Outcomes