Large multi-center study to test videogame-like digital therapy as (potentially) FDA-cleared ADHD treatment
"Akili Labs has kicked off open enrollment for a clinical trial of its Project EVO video game platform in a quest to secure for 510(k) clearance from the U.S. Food and Drug Administration for its lead indication — attention deficit hyperactivity disorder.
The trial is recruiting at least 300 participants aged 8-12 years old who have been diagnosed with ADHD. It will evaluate the safety and efficacy of the Project EVO platform, according to a company statement. The ultimate goal is to provide a drug alternative for children with ADHD and Akili Labs CEO Eddie Martucci views digital therapeutics as the way to do that…If the trial meets its endpoints, the company plans to submit Project EVO for FDA approval.
In a phone interview in February Martucci said, "We want this to stand alongside Adderall and other drugs as a doctor-prescribed treatment."
- Brief summary: The purpose of this study is to evaluate the effects of videogame-like digital therapies on attentional functioning and symptoms in children diagnosed with ADHD.
- Description: The study will be a randomized, parallel group, controlled trial of two videogame-like (iPad-based) digital therapies. The study will consist of 3 primary phases: Screening, Washout/Baseline, and Treatment. During the Screening Phase (Day -28 to Day -7), participants will undergo screening to evaluate eligibility for the study. Screening may take place up to 28 days before the Baseline Visit (Day 0). For those children currently on medication for ADHD the Washout period will begin 7 days prior to Baseline where treatment will be discontinued. On Day 0, the Baseline visit will occur wherein additional eligibility criteria will be established. The Treatment Phase (Day 1 to Day 27) will involve using the digital therapy at home for each participant followed by an In-Clinic assessment on Day 28 to assess key outcomes. Compliance with treatment/use requirements will be monitored remotely during this phase.
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