NCT02822937

Sensitivity of Project: EVO Monitor Cognitive Measurements to Pharmacological Agents

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Akili Interactive Labs, Inc. · Industry
• Sex: All
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Methylphenidate	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.
DRUG	Triazolam	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).
OTHER	Project: EVO	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.
DRUG	Placebo	Sugar pill

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-07-06
• Last updated: 2016-11-07

Locations

1 site across 1 country: United States