Biomarkers, PharmacologicalNCT01194336
Evaluation of Three Potential Central Nervous System (CNS) Pretreatments for Soman Exposure on Human Performance
An observational study of Biomarkers, Pharmacological, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomarkers, Pharmacological
- What is being tested?
- Huperzine A, Donepezil and Galantamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults (18-39 years) males and females, military or civilian
Who may be able to join
- All healthy men and women 18 to 39 years of age are eligible to participate.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
About this study
Official title: 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.
Read the 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
- Being tested
- Huperzine A, Donepezil, Galantamine, Placebo
- Keywords
- Central nervous system, Cholinesterase, Neurocognitive performance testing
- Medical subject headings
- Butyrylcholinesterase deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huperzine ADrug
dosage form: tablet dose frequency: once only
DonepezilDrug
dosage form: tablet dosage frequency: once only
GalantamineDrug
dosage form: tablet dosage frequency: once only
PlaceboOther
dosage form: tablet dosage frequency: once only
| Study group | Role | What they receive |
|---|---|---|
| Huperzine A: 100 ug | Not described Receives: Drug: Huperzine A | |
| Huperzine A: 200 ug | Not described Receives: Drug: Huperzine A | |
| Donepezil: 2.5 mg | Not described Receives: Drug: Donepezil | |
| Donepezil: 5 mg | Not described Receives: Drug: Donepezil | |
| Galantamine: 4 mg | Not described Receives: Drug: Galantamine | |
| Galantamine: 8 mg | Not described Receives: Drug: Galantamine | |
| Placebo | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 6pm Day 1 to 7pm Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomarkers, PharmacologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- MAJ James E Moon, MC, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194336
- Sponsor's protocol ID
- WRAIR 1650
- Other IDs
- A-16072
- Status last verified
- May 2017
- First submitted
- 31 Aug 2010
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three Potential CNS Pretreatments for Soman Exposure - Huperzine A, Donepezil, and Galantamine - on Human Performance
- ClinicalTrials.gov ID
- NCT01194336
- Acronym / sponsor ID
- WRAIR 1650
- Conditions
- Biomarkers, Pharmacological
- Keywords
- Central nervous system, Cholinesterase, Neurocognitive performance testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Institute of Research (WRAIR)
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults (18-39 years) males and females, military or civilian
Key inclusion criteria (1 listed)
- All healthy men and women 18 to 39 years of age are eligible to participate.
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huperzine Adosage form: tablet dose frequency: once only | Drug | Huperzine A: 100 ug, Huperzine A: 200 ug |
| Donepezildosage form: tablet dosage frequency: once only | Drug | Donepezil: 2.5 mg, Donepezil: 5 mg |
| Galantaminedosage form: tablet dosage frequency: once only | Drug | Galantamine: 4 mg, Galantamine: 8 mg |
| Placebodosage form: tablet dosage frequency: once only | Other | Placebo |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MAJ James E Moon, MC principal investigator
Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarkers, Pharmacological, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.