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CompletedNCT03445104Updated May 31, 2018

Effect of Huperzine A on Cognitive Function and Perception of Effort During Exercise

An Early Phase 1 interventional study of Huperzine A and Placebo in Cognitive Enhancement During Exercise, sponsored by St. Louis University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by St. Louis University · Early Phase 1, Interventional, and Other

Phase
Early Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,858 studies in Motor Activity with a site in United States — 423 open to participants now, 564 under way, 9 of them phase 3. Motor Activity · United States.

Enrollment
2,281st of 2,605
15 · median 55
Started
2018
with 169 others
Phase 1
103 of 2,858
10 open now
Registered
1,420th of 2,858
by date

Among the 2,858 studies in Motor Activity with a site in United States, this one is the 2,281st largest by enrollment of the 2,605 interventional ones that give a count, is one of 170 that started in 2018, is one of 103 in phase 1, and was the 1,420th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

423 of the 2,858 studies in Motor Activity with a site in United States are open now. Recruiting first, the newest first:

418 more — sign in →

All 423 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

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02

Study summary

This study evaluates the effects of acute huperzine A ingestion prior to exercise on cognitive function and perceived effort in exercise-trained individuals. Huperzine A has shown the ability to improve cognitive function in dementia patients, and is currently marketed as a cognitive enhancing supplement. Study participants will receive either huperzine A or placebo during the first experimental session, and will receive the other substance during the second session.

Read the detailed description

Huperzine A improves cognitive function by inhibiting the enzyme acetylcholinesterase. This enzyme is responsible for the degradation of the neurotransmitter acetylcholine. inhibition of acetylcholinesterase may allow for greater availability of acetylcholine, which may allow for better nerve conduction and therefore enhanced cognitive function and possibly muscular contraction.

Huperzine A (200 mcg, Swanson®, Fargo, North Dakota) and placebo capsules will be administered in a single oral dose. The dose of Huperzine A to be used is comparable to previous research (Xu et al, 2011). Placebo capsules will consist of rice flour. The participants will ingest the capsules with 250 mL of water 30-45 minutes before exercise is initiated.

A paired-sample t-test with alpha set to p ≤ 0.05 for statistical significance will be used to analyze the data. Outcomes measured during the first and second experimental sessions will be compared to each other. The participants will be compared to themselves during previous sessions, so a paired sample t-test will be used to calculate the difference between the sessions. Data will be presented as means ± SE. Data analyses will be performed with Microsoft Excel; and other analyses may be performed as needed to gain further insights about the data.

A statistical power analysis was performed (G*Power software, version 3.1.5, University of Kiel, University of Dusseldorf, and University of Mannheim, 157 Germany) based on the following inputs: two-tailed paired t-test, alpha=0.05, desired power=0.80, sample size=15 subjects. The results indicated that a standardized effect size of 0.78 (i.e. large effect) will be detectable. As many as 20 subjects will be recruited and enrolled to ensure that complete data on 15 subjects are available in the event of screen fails and dropouts.

03

Conditions studied

  • Cognitive Enhancement During Exercise

Browse trials for

Keywords

  • Huperzine A
  • acetylcholinesterase inhibitor
  • AChEI
  • exercise
  • Physical performance
  • cognitive function
  • rating of perceived exertion
  • RPE
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women of all ethnic and racial groups that participate in endurance exercise of moderate to vigorous intensity at least three days per week, for at least 20 minutes per session, for at least six months prior to this study

Exclusion criteria

Exclusion Criteria:

  • Anyone not within the age range listed in section 8a will be excluded. Individuals who require medical clearance to participate in vigorous exercise based on ACSM's risk assessment algorithm will be excluded from the study. The participant screening form will be used to identify signs and symptoms or medical conditions that require medical clearance to participate in vigorous exercise.
05

Study design

Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Huperzine A

    Huperzine A will be provided in the form of a single capsule for oral ingestion.

    Other: Huperzine A

  • Placebo comparator
    Rice Flour

    Placebo will be provided in the form of a single capsule for oral ingestion.

    Other: Placebo

Interventions

  • OtherHuperzine A

    During one of the two experimental sessions, participants will be given huperzine A.

  • OtherPlacebo

    During one of the two experimental sessions, participants will be given a placebo.

06

What researchers measure

Primary outcomes

  1. Digit span

    Digit span will be used as a measure of working memory. During a period of two minutes, the participants will be presented with a series of digits at a rate of one digit per second, and will be required to to repeat them verbatim. If they succeed, they will be presented with a longer series by one digit. The longest series that they are able to correctly repeat will be the number of their score (i.e. if they are able to repeat a series of 7 digits, their score will be 7).

    Time frame: This test will be implemented during a 2 minute window during the last 10 minutes of endurance exercise.

  2. Verbal Fluency

    Verbal fluency will be used as a measure of executive function. Participants will be instructed to generate words beginning with F, A, S, B, H, or R. Each participant will be randomly assigned a different letter at each session.

    Time frame: This test will be implemented during a 1 minute window during the last 10 minutes of endurance exercise.

  3. Category Fluency

    Category fluency will be used as a measure of executive function. Participants will be instructed to produce as many words as they can for a particular category within one minute. Each participant will be randomly assigned a different category at each session.

    Time frame: This test will be implemented during a 1 minute window during the last 10 minutes of endurance exercise.

  4. Stroop Effect Test

    The Stroop effect test will be used as a measure of information processing. Participants will be exposed to color names printed in an ink color that does not match the color name. They will be instructed to name the color of the ink and to ignore the color name.

    Time frame: This test will be implemented during a 2 minute window during the last 10 minutes of endurance exercise.

07

Study locations

1 site
  • Allied Health Professional Building
    Saint Louis, Missouri 63139, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Apr 2018, 2 months.

Of 73 non-industry phase 1 interventional studies under Motor Activity, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 2 months is below that.

Counting every sponsor, half of 75 studies reached it within 20 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 26, 2018
StartActual
Jan 16, 2018
Primary completionActual
Apr 5, 2018
CompletionActual
Apr 5, 2018
Last update
May 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03445104
Responsible party
Chad Wessinger, BS (Graduate Assistant, St. Louis University) — Principal investigator
First posted
Feb 26, 2018
Start date
Jan 16, 2018
Primary completion
Apr 5, 2018
Completion
Apr 5, 2018
Last update
May 31, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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