Evaluation of Three Potential Central Nervous System (CNS) Pretreatments for Soman Exposure on Human Performance

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Collaborator: Walter Reed Army Institute of Research (WRAIR)
• Treatments: Donepezil; Galantamine; Huperzine A

Criteria

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-reported history of caffeine use in excess of 400 mg (8 caffeinated sodas or 3-4 cups, each ~ 6 oz, of coffee) per day on average

• Pregnancy (females)

• Breast-feeding (females)

• Prior anaphylactic reaction, angioedema, or other severe psychological reactions to any of the test compounds