Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents

NCT02822937 | Completed

• 1 other identifier: Akili-027
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

  Measurements taken 120 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks

• 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

  Measurements taken 120 min post drug with a comparison between 3 clinic visits (each with different drug) over 2 weeks

Secondary Outcomes (4)

• 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

  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

• 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

  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

• 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

  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

• 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

  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

Study Arms (6)

Placebo, Methylphenidate, Triazolam

EXPERIMENTAL

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.

Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo

Placebo, Triazolam, Methylphenidate

EXPERIMENTAL

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.

Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo

Methylphenidate, Placebo, Triazolam

EXPERIMENTAL

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.

Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo

Methylphenidate, Triazolam, Placebo

EXPERIMENTAL

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.

Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo

Triazolam, Placebo, Methylphenidate

EXPERIMENTAL

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.

Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo

Triazolam, Methylphenidate, Placebo

EXPERIMENTAL

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.

Drug: Methylphenidate; Drug: Triazolam; Other: Project: EVO; Drug: Placebo

Interventions

Methylphenidate DRUG

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.

Also known as: Ritalin

Methylphenidate, Placebo, Triazolam; Methylphenidate, Triazolam, Placebo; Placebo, Methylphenidate, Triazolam; Placebo, Triazolam, Methylphenidate; Triazolam, Methylphenidate, Placebo; Triazolam, Placebo, Methylphenidate

Triazolam DRUG

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).

Also known as: Halcion

Methylphenidate, Placebo, Triazolam; Methylphenidate, Triazolam, Placebo; Placebo, Methylphenidate, Triazolam; Placebo, Triazolam, Methylphenidate; Triazolam, Methylphenidate, Placebo; Triazolam, Placebo, Methylphenidate

Project: EVO OTHER

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.

Also known as: Cognitive Monitor

Methylphenidate, Placebo, Triazolam; Methylphenidate, Triazolam, Placebo; Placebo, Methylphenidate, Triazolam; Placebo, Triazolam, Methylphenidate; Triazolam, Methylphenidate, Placebo; Triazolam, Placebo, Methylphenidate

Placebo DRUG

Sugar pill

Also known as: Sugar Pill

Methylphenidate, Placebo, Triazolam; Methylphenidate, Triazolam, Placebo; Placebo, Methylphenidate, Triazolam; Placebo, Triazolam, Methylphenidate; Triazolam, Methylphenidate, Placebo; Triazolam, Placebo, Methylphenidate

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akili Interactive Labs, Inc.: lead

Study Sites (1)

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Methylphenidate; Triazolam; Sugars

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Study Officials

• Ted Riley

  ProMedica International

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: July 6, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 7, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)