Approaches to measuring the effects of wake-promoting drugs: a focus on cognitive function.
OBJECTIVE
In clinical drug development, wakefulness and wake-promotion may be assessed by a large number of scales and questionnaires. Objective assessment of wakefulness is most commonly made using sleep latency/maintenance of wakefulness tests, polysomnography and/or behavioral measures. The purpose of the present review is to highlight the degree of overlap in the assessment of wakefulness and cognition, with consideration of assessment techniques and the underlying neurobiology of both concepts.


METHODS
Reviews of four key areas were conducted: commonly used techniques in the assessment of wakefulness; neurobiology of sleep/wake and cognition; targets of wake promoting and/or cognition enhancing drugs; and ongoing clinical trials investigating wake promoting effects.


RESULTS
There is clear overlap between the assessment of wakefulness and cognition. There are common techniques which may be used to assess both concepts; aspects of the neurobiology of both concepts may be closely related; and wake-promoting drugs may have nootropic properties (and vice versa). Clinical trials of wake-promoting drugs often, though not routinely, assess aspects of cognition.


CONCLUSIONS
Routine and broad assessment of cognition in the development of wake-promoting drugs may reveal important nootropic effects, which are not secondary to alertness/wakefulness, whilst existing cognitive enhancers may have underexplored or unknown wake promoting properties.
Edgar
Christopher J
CJ
chris@cognitionstudy.com
Pace-Schott
Edward F
EF
Wesnes
Keith A
KA
D001921:Brain / Q000033:anatomy & histology / Q000187:drug effects / Q000502:physiology; D000697:Central Nervous System Stimulants / Q000494:pharmacology*; D002940:Circadian Rhythm / Q000187:drug effects; D002986:Clinical Trials as Topic; D003071:Cognition / Q000187:drug effects*; D006801:Humans; D009483:Neuropsychological Tests; D012890:Sleep / Q000187:drug effects; D011795:Surveys and Questionnaires; D014851:Wakefulness / Q000187:drug effects* / Q000502:physiology*
D000697:Central Nervous System Stimulants