Evaluation of Three Potential CNS Pretreatments for Soman Exposure - Huperzine A, Donepezil, and Galantamine - on Human Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Observe military relevant neurocognitive performance in humans taking huperzine A, donepezil and galantamine compared to placebo.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All healthy men and women 18 to 39 years of age are eligible to participate.
排除标准
- •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
研究组 & 干预措施
Huperzine A: 100 ug
干预措施: Huperzine A (Drug)
Huperzine A: 200 ug
干预措施: Huperzine A (Drug)
Donepezil: 2.5 mg
干预措施: Donepezil (Drug)
Donepezil: 5 mg
干预措施: Donepezil (Drug)
Galantamine: 4 mg
干预措施: Galantamine (Drug)
Galantamine: 8 mg
干预措施: Galantamine (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Observe military relevant neurocognitive performance in humans taking huperzine A, donepezil and galantamine compared to placebo.
时间窗: 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.
次要结局
- 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)