Trial record 8 of 9 for:    HUPERZINE A

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
  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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • 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.


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. [ 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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194336

Locations
United States, Maryland
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Institute of Research (WRAIR)
Investigators
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:
Huperzine A
Galantamine
Donepezil
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 July 22, 2014