Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-02 @ 6:07 AM
Study NCT ID:
NCT03844269
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2019-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Electroencephalogram (EEG) Study of Inattention Following Treatment With AKL-T01
Sponsor:
Akili Interactive Labs, Inc.
Organization:
Study Overview
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
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: