Biomarkers, Pharmacological
Conditions
Keywords
Central nervous system, Cholinesterase, Neurocognitive performance testing
Brief 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.
Detailed description
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. Secondary: Secondary objectives are to correlate neurocognitive performance effects with degree of inhibition and therefore sequestration of red blood cell AChE by huperzine A, donepezil, and galantamine, and to monitor the safety of the study drugs in healthy adult (18-39 years) males and females. In a double-blind, randomized, placebo-controlled, parallel-groups design, normal, healthy, adult male and female volunteers will be administered one of the drug/doses. They will be tested prior to and periodically for militarily relevant performance tasks for up to 8 hours post-dose and for cholinesterase levels via finger prick.
Interventions
DRUGHuperzine A
dosage form: tablet dose frequency: once only
DRUGDonepezil
dosage form: tablet dosage frequency: once only
DRUGGalantamine
dosage form: tablet dosage frequency: once only
OTHERPlacebo
dosage form: tablet dosage frequency: once only
Sponsors
Walter Reed Army Institute of Research (WRAIR)
U.S. Army Medical Research and Development Command
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observe military relevant neurocognitive performance in humans taking huperzine A, donepezil and galantamine compared to placebo. | 6pm Day 1 to 7pm Day 2 | The primary objective of this study is to determine whether huperzine A (a nutraceutical), donepezil (Aricept®), and galantamine (Razadyne®), impact militarily relevant aspects of neurocognitive performance in humans, compared to placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlate neurocognitive performance effects of huperzine A, donepezil and galantamine and to monitor the safety of the study drugs in healthy adults. | 6pm Day 1 to 7pm Day 2 | Secondary objectives are to correlate neurocognitive performance effects with degree of sequestration of red blood cell AChE by huperzine A, donepezil, and galantamine, and to monitor the safety of the study drugs in healthy adults. |
Countries
United States
Outcome results
None listed