NCT03649074

Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant

Software Treatment for Actively Reducing Severity of ADHD as Adjunctive Treatment to Stimulant (STARS-ADHD Adjunctive)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Akili Interactive Labs, Inc. · Industry
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effects of combining AKL-T01 (with AKL-X01 symptom tracking) as adjunctive treatment to stimulant medication, and to understand the effects of AKL-T01 treatment (with AKL-X01 symptom tracking) in participants not recently on medication.

Detailed description

The study aims to enroll (203) participants, with a confirmed diagnoses of ADHD, at approximately 15 sites and will be divided between 2 cohorts; 130 participants will be enrolled in Cohort 1, and 73 participants will be enrolled in Cohort 2. Cohort 1 will have been stable (adherence to a prescribed medication schedule) on a stimulant medication, but are inadequately managed by the stimulant (in the opinion of the investigator). The stimulant is managed by their own physician for at least 30 days before baseline. This is the Stimulant cohort. Cohort 2 will have been stable without any stimulant medication for at least 30 days before the baseline. This is the Non-Stimulant cohort. For both cohorts, at least 7 and up to 30 days before baseline, participants' caretakers will begin using AKL-X01 (Fengo) to track their participants' symptoms and behaviors. During Treatment Phase 1 (Days 1 through 28) participants in Cohort 1 (Stimulant) will continue to receive their current stimulant plus the addition of AKL-T01. Participants in Cohort 2 (Non-Stimulant) will just receive AKL-T01. For both cohorts, during this time the caretakers will monitor their child's symptoms daily with AKL-X01. During the 1-Month Break (Days 29 through 56) between AKL-T01 treatment phases, participants in Cohort 1 will continue to receive their current stimulant. In both cohorts, AKL-T01 will be suspended during this time. For both cohorts, during this time caretakers will continue to monitor their child's symptoms daily with AKL-X01. During Treatment Phase 2 (Days 57 through 84), participants in Cohort 1 (stimulant) will continue to receive their current stimulant plus the addition of AKL-T01. Participants in Cohort 2 will just receive AKL-T01. For both cohorts, during this time the caretakers will monitor their child's symptoms daily with AKL-X01. AKL-T01, or EVO Multi, is a digital intervention that requires the subject to navigate a character through a game-like space, while collecting objects, in a fixed period of time. AKL-T01: Videogame-like digital therapy

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: 2018-12-28
• Primary completion: 2019-09-23
• Completion: 2019-09-23
• First posted: 2018-08-28
• Last updated: 2023-08-09
• Results posted: 2023-08-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study