NCT01194336

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Biomarkers, Pharmacological

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2010-09-03
• Last updated: 2017-05-03

Locations

1 site across 1 country: United States