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Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Triazolam
Project: EVO
Placebo
Sponsored by
Akili Interactive Labs, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

40 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinical Trials of Texas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo, Methylphenidate, Triazolam

Placebo, Triazolam, Methylphenidate

Methylphenidate, Placebo, Triazolam

Methylphenidate, Triazolam, Placebo

Triazolam, Placebo, Methylphenidate

Triazolam, Methylphenidate, Placebo

Arm Description

The participants will receive placebo on the first day, 40mg Methylphenidate on the second day, and 0.375mg Triazolam on the third day. All drug administration and cognitive measurement 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.

The participants will receive placebo on the first day, 0.375mg Triazolam on the second day, and 40mg Methylphenidate on the third day. All drug administration and cognitive measurement 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.

The participants will receive 40mg Methylphenidate on the first day, placebo on the second day, and 0.375mg Triazolam on the third day. All drug administration and cognitive measurement 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.

The participants will receive 40mg Methylphenidate on the first day, 0.375mg Triazolam on the second day, and placebo on the third day. All drug administration and cognitive measurement 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.

The participants will receive 0.375mg Triazolam on the first day, placebo on the second day, and 40mg Methylphenidate on the third day. All drug administration and cognitive measurement 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.

The participants will receive 0.375mg Triazolam on the first day, 40mg Methylphenidate on the second day, and placebo on the third day. All drug administration and cognitive measurement 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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
June 2, 2016
Last Updated
November 3, 2016
Sponsor
Akili Interactive Labs, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02822937
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akili Interactive Labs, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo, Methylphenidate, Triazolam
Arm Type
Experimental
Arm Description
The participants will receive placebo on the first day, 40mg Methylphenidate on the second day, and 0.375mg Triazolam on the third day. All drug administration and cognitive measurement 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.
Arm Title
Placebo, Triazolam, Methylphenidate
Arm Type
Experimental
Arm Description
The participants will receive placebo on the first day, 0.375mg Triazolam on the second day, and 40mg Methylphenidate on the third day. All drug administration and cognitive measurement 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.
Arm Title
Methylphenidate, Placebo, Triazolam
Arm Type
Experimental
Arm Description
The participants will receive 40mg Methylphenidate on the first day, placebo on the second day, and 0.375mg Triazolam on the third day. All drug administration and cognitive measurement 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.
Arm Title
Methylphenidate, Triazolam, Placebo
Arm Type
Experimental
Arm Description
The participants will receive 40mg Methylphenidate on the first day, 0.375mg Triazolam on the second day, and placebo on the third day. All drug administration and cognitive measurement 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.
Arm Title
Triazolam, Placebo, Methylphenidate
Arm Type
Experimental
Arm Description
The participants will receive 0.375mg Triazolam on the first day, placebo on the second day, and 40mg Methylphenidate on the third day. All drug administration and cognitive measurement 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.
Arm Title
Triazolam, Methylphenidate, Placebo
Arm Type
Experimental
Arm Description
The participants will receive 0.375mg Triazolam on the first day, 40mg Methylphenidate on the second day, and placebo on the third day. All drug administration and cognitive measurement 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.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Ritalin
Intervention Description
Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.
Intervention Type
Drug
Intervention Name(s)
Triazolam
Other Intervention Name(s)
Halcion
Intervention Description
Triazolam is a benzodiazepine similar to Valium. Triazolam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia). Triazolam is used to treat insomnia (trouble falling or staying asleep).
Intervention Type
Other
Intervention Name(s)
Project: EVO
Other Intervention Name(s)
Cognitive Monitor
Intervention Description
Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Sugar pill
Primary Outcome Measure Information:
Title
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
Time Frame
Measurements taken 120 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks
Title
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
Time Frame
Measurements taken 120 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
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
Title
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
Time Frame
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
Title
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
Time Frame
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
Title
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
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 40-55 at the time of informed consent Ability to follow written and verbal instructions (English). Weight between 140 lbs and 240 lbs. Male and female (Gender-matched). Ability to comply with all the testing and requirements. Exclusion Criteria: Known adverse reaction to study medications. Known non-response or paradoxical response to study medications. 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. 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. Current diagnosis of severe learning disorder, dyslexia, or dyscalculia. Current subjective complaints of inattention or memory loss. Currently undergoing psychotherapy, behavioral therapy, or occupational therapy. Current use of psychotropic medication, prescription or otherwise. Motor condition that prevents game playing, as reported by parent or observed by investigator. Impaired visual acuity, as defined by difficulty reading the informed consent even with corrective lenses. Lifetime history of suspected substance abuse or dependence. 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. History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, a current diagnosis of Tourette's Disorder. Taken part in a clinical trial within 30 days prior to screening. Diagnosis of or patient-reported color blindness. Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments. Pregnancy. Currently nursing or breastfeeding. Resting heart rate > 100 beats/min. Systolic blood pressure > 150 mm/Hg. History of cardiac abnormalities. History of glaucoma. 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. Any other medical condition that in the opinion of the investigator may confound study data/assessments. Any other medical condition that in the opinion of the investigator prohibits the administration of any study medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ted Riley
Organizational Affiliation
ProMedica International
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents

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