Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents



Status:Not yet recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:40 - 55
Updated:7/7/2016
Start Date:June 2016
End Date:August 2016
Contact:Ted Riley
Email:triley@promedica-intl.com
Phone:714-460-7363

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A Study to Assess the Sensitivity of Project: EVO Monitor Cognitive Function Measurements to Methylphenidate and Triazolam in Adults 40-55 Years Old

This is a study in adults to assess the sensitivity of Project: EVO Monitor cognitive
measurements to two short-acting cognitively active pharmacological agents. The participants
will receive a placebo, and two pharmacological agents in a randomized order for three
in-clinic study days. During each study day in the clinic, the participants will use
Project: EVO Monitor and another cognitive task through the day.

This is a study in adults ages 40 to 55 to assess the sensitivity of Project: EVO Monitor
cognitive measurements to two short-acting cognitively active pharmacological agents,
methylphenidate (MPH) and triazolam (TRZ). The participants will receive a placebo, MPH, and
TRZ in a randomized order for three in-clinic study days. All drug administration and
cognitive testing will take place in the clinic under medical staff supervision. During each
study day in the clinic, the participants will use Project: EVO Monitor and do a short digit
symbol substitution task (DSST) 8 times over the day. A minimum of 48 hours will be needed
between each study day. The investigators plan to evaluate 18 participants in this study.

Inclusion Criteria:

1. Age 40-55 at the time of informed consent

2. Ability to follow written and verbal instructions (English).

3. Weight between 140 lbs and 240 lbs.

4. Male and female (Gender-matched).

5. Ability to comply with all the testing and requirements.

Exclusion Criteria:

1. Known adverse reaction to study medications.

2. Known non-response or paradoxical response to study medications.

3. Current, controlled (requiring a restricted medication) or uncontrolled,
self-reported psychiatric diagnosis with significant symptoms such as post-traumatic
stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe
obsessive compulsive disorder, severe depressive or anxiety disorder, conduct
disorder, attention deficit disorder, autism spectrum disorder, or other symptomatic
manifestations that in the opinion of the Investigator that may confound study
data/assessments.

4. Current self-reported community diagnosis of cognitive ailments such as dementia,
Alzheimer's disease, stroke, traumatic brain injury, or other diseases that in the
opinion of the Investigator that may confound study data/assessments.

5. Current diagnosis of severe learning disorder, dyslexia, or dyscalculia.

6. Current subjective complaints of inattention or memory loss.

7. Currently undergoing psychotherapy, behavioral therapy, or occupational therapy.

8. Current use of psychotropic medication, prescription or otherwise.

9. Motor condition that prevents game playing, as reported by parent or observed by
investigator.

10. Impaired visual acuity, as defined by difficulty reading the informed consent even
with corrective lenses.

11. Lifetime history of suspected substance abuse or dependence.

12. Current use (defined as within the last 30 days) of products with nicotine, e.g.
cigarettes, chewing tobacco, e-cigarettes, nicotine patch, and nicotine gum.

13. History of seizures (exclusive of febrile seizures), a tic disorder, significant
tics, a current diagnosis of Tourette's Disorder.

14. Taken part in a clinical trial within 30 days prior to screening.

15. Diagnosis of or patient-reported color blindness.

16. Regular use of psychoactive drugs that in the opinion of the Investigator may
confound study data/assessments.

17. Pregnancy.

18. Currently nursing or breastfeeding.

19. Resting heart rate > 100 beats/min.

20. Systolic blood pressure > 150 mm/Hg.

21. History of cardiac abnormalities.

22. History of glaucoma.

23. Current use of monoamine oxidase inhibitors, HIV protease inhibitors, ranitidine,
isoniazid, ketoconazole, itraconazole, nefazodone and other azole-type antifungal
agents or any other drugs that are contra-indicated for use with study medications.

24. Any other medical condition that in the opinion of the investigator may confound
study data/assessments.

25. Any other medical condition that in the opinion of the investigator prohibits the
administration of any study medication.
We found this trial at
1
site
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
Principal Investigator: Jason Miller, OD
?
mi
from
San Antonio, TX
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