Evaluation of Three Potential Central Nervous System (CNS) Pretreatments for Soman Exposure on Human Performance
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Biomarkers, Pharmacological |
Drug: Huperzine A Drug: Donepezil Drug: Galantamine Other: Placebo |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Evaluation of Three Potential CNS Pretreatments for Soman Exposure - Huperzine A, Donepezil, and Galantamine - on Human Performance |
- Observe military relevant neurocognitive performance in humans taking huperzine A, donepezil and galantamine compared to placebo. [ Time Frame: 6pm Day 1 to 7pm Day 2 ] [ Designated as safety issue: Yes ]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.
- Correlate neurocognitive performance effects of huperzine A, donepezil and galantamine and to monitor the safety of the study drugs in healthy adults. [ Time Frame: 6pm Day 1 to 7pm Day 2 ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 84 |
| Study Start Date: | February 2012 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Huperzine A: 100 ug |
Drug: Huperzine A
dosage form: tablet dose frequency: once only
|
| Huperzine A: 200 ug |
Drug: Huperzine A
dosage form: tablet dose frequency: once only
|
| Donepezil: 2.5 mg |
Drug: Donepezil
dosage form: tablet dosage frequency: once only
|
| Donepezil: 5 mg |
Drug: Donepezil
dosage form: tablet dosage frequency: once only
|
| Galantamine: 4 mg |
Drug: Galantamine
dosage form: tablet dosage frequency: once only
|
| Galantamine: 8 mg |
Drug: Galantamine
dosage form: tablet dosage frequency: once only
|
| Placebo |
Other: Placebo
dosage form: tablet dosage frequency: once only
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 39 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Healthy adults (18-39 years) males and females, military or civilian
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
Contacts and Locations| United States, Maryland | |
| Walter Reed Army Institute of Research | |
| Silver Spring, Maryland, United States, 20910 | |
| Principal Investigator: | MAJ James E Moon, MC | Walter Reed Army Institute of Research (WRAIR) |
More Information
No publications provided
| Responsible Party: | U.S. Army Medical Research and Materiel Command |
| ClinicalTrials.gov Identifier: | NCT01194336 History of Changes |
| Other Study ID Numbers: | WRAIR 1650 |
| Study First Received: | August 31, 2010 |
| Last Updated: | November 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by U.S. Army Medical Research and Materiel Command:
|
Central nervous system Cholinesterase Neurocognitive performance testing |
Additional relevant MeSH terms:
|
Galantamine Donepezil Huperzine A Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nootropic Agents |
Central Nervous System Agents Therapeutic Uses Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on June 18, 2013