Evaluation of Three Potential Central Nervous System (CNS) Pretreatments for Soman Exposure on Hu… (NCT01194336) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Three Potential Central Nervous System (CNS) Pretreatments for Soman Exposure on Human Performance
United States84 participantsStarted 2012-02
Plain-language summary
The primary objective of this study is to determine whether huperzine A, donepezil, and galantamine impact militarily relevant aspects of neurocognitive performance in humans, compared to placebo.
Who can participate
Age range18 Years – 39 Years
SexALL
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Inclusion Criteria:
* All healthy men and women 18 to 39 years of age are eligible to participate.
Exclusion Criteria:
Must be able to swallow whole pills.
* Self-reported habitual nightly sleep amounts outside the target range of 6-8 hours (i.e., less than 6 hours per night or more than 8 hours per night, on average)
* Cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, family history of sudden cardiac death or myocardial infarction) as determined by participant self report.
* Current hypertension or high blood pressure (greater than 140/90)
* Neurologic disorder (to include but not limited to epilepsy or another seizure disorder, amnesia for any reason, hydrocephalus, MS, narcolepsy or other sleep disorders)
* Kidney disease
* History of psychiatric disorder requiring hospitalization or psychiatric medication for any length of time
* Beck Depression Inventory score of 14 or above
* Underlying pulmonary disease requiring daily inhaler use
* Regular nicotine use (or addiction) (defined as more than 1 cigarette or equivalent per week) within the last 3 years
* Heavy alcohol use (more than 2 drinks per day; http://www.cdc.gov/alcohol/faqs.htm#10)
* Use of other illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana)
* Known liver disease or liver abnormalities as determined by a laboratory test
* Known ulcer disease or risk of ulcer disease (stomach bleeding)
* Self-repo…
What they're measuring
1
Observe military relevant neurocognitive performance in humans taking huperzine A, donepezil and galantamine compared to placebo.
Timeframe: 6pm Day 1 to 7pm Day 2
Trial details
NCT IDNCT01194336
SponsorU.S. Army Medical Research and Development Command