Akili Interactive Announces Trial Results for Video Game Treatment of ADHD

| Printer friendly version

Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01.  According to FierceBiotech, Akili plans to file AKL-T01 with the U.S. Food and Drug Administration (FDA) for clearance under the 510(k) medical device pathway as a novel treatment for children and adolescents with attention deficit/hyperactivity disorder (ADHD).

According to the article, unlike traditional drug treatments for ADHD, AKL-T01, also known as Project: EVO, is a video game patients play on a tablet device.  AKL-T01 uses storytelling and reward

mechanisms, like those found in standard video games, and further uses adaptive algorithms to automatically adjust the level of stimulus up or down to target deficient cognitive neural systems in the brain and meet the specific needs of the patient.

The article further notes that in the randomized, controlled trial, 348 children and adolescents diagnosed with ADHD were evaluated before and after four weeks of at-home treatment with either AKL-T01 or an active control.  According to Akili’s press release, children and adolescents who used AKL-T01 showed a statistically significant improvement in attentional functional compared to the children in the active control group.  According to Akili, a full analysis of the results is underway and will be presented in upcoming peer-reviewed publications, scientific conferences, and medical meetings.

The use of interactive software as digital treatment is a relatively new trend.  The FDA recently approved what it characterized as its first-ever mobile medical application, an application developed by Pear Therapeutics to treat substance use disorders.  As reported by Reuters, Akili’s plan to file for FDA approval may pave the way for what would be the first such digital prescription product to tackle ADHD.  Considering that Pear Therapeutics was recently selected to participate in the FDA’s digital health software precertification pilot program, the FDA has provided an indication that the agency may be interested in the type of digital therapy treatment Akili claims to offer.

 

 

Benjamin Ho
Benjamin Ho's practice includes patent prosecution and litigation relating to electronic, software, and communication technologies. Benjamin attended college at New York University, where he graduated with degrees in both Computer Science and Economics. He received his Juris Doctor from Cornell Law School, where he was Managing Editor of the Journal of Law and Public Policy. Benjamin worked as a summer associate at the firm in 2016 and joined the firm in 2017.
View all posts published by Benjamin Ho »

Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.