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

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01194336
First received: August 31, 2010
Last updated: November 27, 2012
Last verified: November 2012

August 31, 2010
November 27, 2012
February 2012
October 2012   (final data collection date for primary outcome measure)
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.
Observe military relevant neurocognitive performance in humans taking huperzine A, donepezil and galantamine compared to placebo and positive control. [ 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 and positive control (scopolamine).
Complete list of historical versions of study NCT01194336 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Evaluation of Three Potential Central Nervous System (CNS) Pretreatments for Soman Exposure on Human Performance
Evaluation of Three Potential CNS Pretreatments for Soman Exposure - Huperzine A, Donepezil, and Galantamine - on Human Performance

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Healthy adults (18-39 years) males and females, military or civilian

Biomarkers, Pharmacological
  • Drug: Huperzine A
    dosage form: tablet dose frequency: once only
  • Drug: Donepezil
    dosage form: tablet dosage frequency: once only
  • Drug: Galantamine
    dosage form: tablet dosage frequency: once only
  • Other: Placebo
    dosage form: tablet dosage frequency: once only
  • Huperzine A: 100 ug
    Intervention: Drug: Huperzine A
  • Huperzine A: 200 ug
    Intervention: Drug: Huperzine A
  • Donepezil: 2.5 mg
    Intervention: Drug: Donepezil
  • Donepezil: 5 mg
    Intervention: Drug: Donepezil
  • Galantamine: 4 mg
    Intervention: Drug: Galantamine
  • Galantamine: 8 mg
    Intervention: Drug: Galantamine
  • Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 39 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01194336
WRAIR 1650
No
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
Walter Reed Army Institute of Research (WRAIR)
Principal Investigator: MAJ James E Moon, MC Walter Reed Army Institute of Research (WRAIR)
U.S. Army Medical Research and Materiel Command
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP