NCT05183919

Software Treatment for Actively Reducing Severity of ADHD in Adults (STARS ADHD Adult)

A Single Arm, Adaptive Design, Pivotal Trial to Assess the Efficacy of AKL-T01, a Novel Digital Intervention Designed to Improve Attention, in Adults Diagnosed With Attention Deficit Hyperactive Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Akili Interactive Labs, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This study is a multi-center, unblinded/non-controlled adaptive design study to evaluate objective attention functioning and ADHD symptoms and impairments in adults with a diagnosis of ADHD (combined or inattentive subtype), stably on or off ADHD medication, after 6 weeks of AKL-T01 treatment. A maximum of 325 total participants from 12-30 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 2-42) 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 42 to assess key outcomes.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
OTHER	Digital Treatment	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: 2021-11-29
• Primary completion: 2023-01-13
• Completion: 2023-01-13
• First posted: 2022-01-11
• Last updated: 2023-02-28

Locations

14 sites across 1 country: United States