NCT04897074

Software Treatment for Actively Reducing Severity of ADHD in Adolescents (STARS-ADHD-Adolescents)

A Single Arm Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adolescents, Aged 13-17 Years Old, Diagnosed With Attention Deficit Hyperactive Disorder (ADHD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Akili Interactive Labs, Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of videogame-like digital therapy on attentional functioning and symptoms in adolescents ages 13-17 diagnosed with ADHD

Detailed description

This study is a multi-center, unblinded/non-controlled study to evaluate objective attention functioning and ADHD symptoms and impairments in adolescents aged 13 to 17 years old, with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 4-weeks of AKL-T01 treatment. Up to 165 total participants from up to 20 sites will be enrolled. During the Screening/baseline, participants will undergo screening to evaluate eligibility for the study. Eligible participants will continue onto baseline procedures in the same visit. Treatment phase (Day 2-27) will involve using the digital therapy at home for each participant. Compliance with treatment/use requirements will be monitored remotely during this phase. An In-Clinic assessment will be completed on Day 28 to assess key outcomes.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DEVICE	AKL-T01	AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor "driving" task.

Timeline

• Start date: 2021-06-29
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-05-21
• Last updated: 2023-08-14

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study