NCT01194336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2010

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

8 months

First QC Date

August 31, 2010

Last Update Submit

May 2, 2017

Conditions

Biomarkers, Pharmacological

Keywords

Central nervous systemCholinesteraseNeurocognitive performance testing

Outcome Measures

Primary Outcomes (1)

  • Observe military relevant neurocognitive performance in humans taking huperzine A, donepezil and galantamine compared to placebo.

    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.

    6pm Day 1 to 7pm Day 2

Secondary Outcomes (1)

  • 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

Study Arms (7)

Huperzine A: 100 ug

Drug: Huperzine A

Huperzine A: 200 ug

Drug: Huperzine A

Donepezil: 2.5 mg

Drug: Donepezil

Donepezil: 5 mg

Drug: Donepezil

Galantamine: 4 mg

Drug: Galantamine

Galantamine: 8 mg

Drug: Galantamine

Placebo

Other: Placebo

Interventions

Huperzine ADRUG

dosage form: tablet dose frequency: once only

Huperzine A: 100 ugHuperzine A: 200 ug
DonepezilDRUG

dosage form: tablet dosage frequency: once only

Donepezil: 2.5 mgDonepezil: 5 mg
GalantamineDRUG

dosage form: tablet dosage frequency: once only

Galantamine: 4 mgGalantamine: 8 mg
PlaceboOTHER

dosage form: tablet dosage frequency: once only

Placebo

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • All healthy men and women 18 to 39 years of age are eligible to participate.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Butyrylcholinesterase deficiency

Interventions

huperzine ADonepezilGalantamine

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsAmaryllidaceae AlkaloidsAlkaloidsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • MAJ James E Moon, MC

    Walter Reed Army Institute of Research (WRAIR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 3, 2010

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

US(1)