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

Sponsor

U.S. Army Medical Research and Development Command (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT01194336

Collaborator

Walter Reed Army Institute of Research (WRAIR) (U.S. Fed)

Enrollment

Location

Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biomarkers, Pharmacological	Drug: Huperzine A Drug: Donepezil Drug: Galantamine Other: 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.

Study Design

Study Type:

Observational

Actual Enrollment :

84 participants

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

All

Accepts 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