Clinical trial NCT02822937: Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents
Official title: A Study to Assess the Sensitivity of Project: EVO Monitor Cognitive Function Measurements to Methylphenidate and Triazolam in Adults 40-55 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Akili Interactive Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-06
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intra-subject sensitivity of Project: EVO cognitive measurements (threshold based) to a cognitive enhancer or a cognitive disruptor at peak drug effects relative to placebo
timeFrame: Measurements taken 120 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks
measure: Intra-subject sensitivity of Project: EVO cognitive measurements (reaction time based) to a cognitive enhancer or a cognitive disruptor at peak drug effects relative to placebo
timeFrame: Measurements taken 120 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks
Secondary outcomes:
measure: Intra-subject sensitivity of Project: EVO cognitive measurements (threshold based) to the cognitive enhancer and cognitive disruptor relative to the placebo measurements using the area-under-the-curve (AUC) analysis
timeFrame: Measurements taken predose and 30, 60, 90, 120, 150, 180, and 240 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks
measure: Intra-subject sensitivity of Project: EVO cognitive measurements (reaction time based) to the cognitive enhancer and cognitive disruptor relative to the placebo measurements using the area-under-the-curve (AUC) analysis
timeFrame: Measurements taken predose and 30, 60, 90, 120, 150, 180, and 240 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks
measure: Intra-subject sensitivity to Project: EVO cognitive measurements (threshold based) with the onset and decline of the predicted drug effects over the study day, using a quadratic regression model
timeFrame: Measurements taken predose and 30, 60, 90, 120, 150, 180, and 240 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks
measure: Intra-subject sensitivity to Project: EVO cognitive measurements (reaction time based) with the onset and decline of the predicted drug effects over the study day, using a quadratic regression model
timeFrame: Measurements taken predose and 30, 60, 90, 120, 150, 180, and 240 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
Study officials:
affiliation: ProMedica International
name: Ted Riley
role: STUDY_DIRECTOR
References: