Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: A Study to Assess Midline Frontal Theta (MFT) Power as Measured by Stimulus-locked Electroencephalography (EEG) Before and After AKL-T01 Treatment for Improving Attention in Pediatric Participants Ages 8-12 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)

Status Completed

Clinical Trial Summary

This study is a single arm, open-label, pilot study to assess midline frontal theta (MFT) power as measured by stimulus-locked electroencephalogram (EEG) before and after treatment with AKL-T01 for improving attention in pediatric participants ages 8-12 years old with attention deficit hyperactivity disorder (ADHD).

Clinical Trial Description

All participants enrolled in this study will not be taking medications for attention deficit hyperactivity disorder (ADHD), including stimulants, for the duration of the study. Participants who are taking ADHD medications prior to Day 0 must have been stable off of medications for at least 30 days per parent report, or washout of medications at a Screening visit 3 - 7 days prior to Day 0.

At Baseline / Day 0, all eligible participants will complete both resting-state electroencephalogram (EEG) and a perceptual discrimination task (PDT)-locked EEG.

All participants will then play AKL-T01 for approximately 25 minutes per day, 5 days per week, for 4 weeks at home.

At Follow-up / Day 28, participants will repeat both resting-state and PDT-locked EEG. ;

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

• NCT number: NCT03844269
• Study type: Interventional
• Source: Akili Interactive Labs, Inc.
• Status: Completed
• Phase: N/A
• Start date: May 10, 2019
• Completion date: February 1, 2020