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The first ever game to be given approval by FDA as a therapeutic for any condition

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Mobi Health News
Author Dave Muoio
Date March 29, 2021

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Akili Interactive has published the full data from its STARS-ADHD Adjunctive trial. The data builds upon the company's pivotal study of AKL-T01 (now available as EndeavorRx) and suggests the videogame-like digital therapeutic delivers benefits with or without accompanying stimulant medication, and that they persist up to one month following the treatment.

"These results increase the generalizability of previous studies and provide further evidence that AKL-T01 is a viable option for improving attention functioning in children with ADHD, including children receiving concurrent pharmacotherapy," researchers wrote in npj Digital Medicine.

The study was funded by Akili, authored by employees and other researchers with ties to the company, and conducted by the Duke Clinical Research Institute.

EndeavorRx is a software treatment for improving symptoms associated with ADHD in children, in which patients navigate an avatar through a course while responding to on-screen prompts. It is intended for use as one component of a broader therapeutic program, as per the product's De Novo clearance from last year.
TOPLINE DATA
Of the study's 206 participants, 95% completed the study through the initial four-week treatment period, 90% through a subsequent four-week pause and 87% through an additional four weeks of treatment after the break. Just shy of 80% of participants played through half of the recommended "missions" during the initial four-week treatment period (down from 85.6% in the company's pivotal trial).

As outlined in an early data reveal in January 2020, study participants who received the digital therapeutic demonstrated ADHD Impairment Rating Scale improvements four weeks after baseline ( p < .001), as well as increases among secondary clinical measures such as the ADHD Rating Scale and the Clinical Global Impression - Improvement Scale. The researchers observed these outcomes both among those who received the digital therapeutic with stimulant medication (n = 130) or without (n = 76).

This primary measure and secondary outcomes held steady over the four-week break ( p <.001), with treatment effects increasing from baseline to the end of the second treatment period in both cohorts. Responder analyses generally supported these trends.

The researchers reported no serious adverse events among the participants, and device-related adverse events among 18% of the children. The majority of parents and children perceived an improvement in participants' ability to pay attention following the trial.

"The findings from this latest study offer additional information about the effectiveness of EndeavorRx in children treated with front-line pharmacotherapy for ADHD," Scott Kollins, professor of psychiatry and director of the ADHD Program at the Duke University School of Medicine, faculty member at the Duke Clinical Research Institute and the study's lead author, said in a statement provided by Akili. "As a clinician who works with children with ADHD, I am happy to see these results from an innovative treatment that can improve both symptoms and impairments in children with ADHD."
HOW IT WAS DONE
The open-label, multisite trial recruited children aged eight to 14 years with an ADHD diagnosis but no other significant comorbid psychiatric diagnoses. These participants were required to either not be receiving stimulant treatment for their ADHD or to be adherent to the stimulant medication for at least 30 days prior to baseline.

Children received the digital treatment for use at home over four weeks, followed by a four-week break and then an additional four weeks of use. The children were instructed to use the treatment five days per week during treatment, with a daily session comprising of five missions that would take roughly four or five minutes to complete.
THE BACKGROUND
The adjunct trial follows last year's full publication of the STARS-ADHD pivotal trial of Akili's product in February 2020. This study compared the treatment to a prescribed sham app, and outlined significant improvements in primary pediatric attention disorder symptoms such as the Test of Variables of Attention Attention Performance Index (TOVA API) - although the case was a bit muddier when looking at some of the secondary measures highlighted in the adjunct trial.

Data from both trials were included as part of the company's FDA submission. Shortly after the digital therapeutic was allowed to launch early due to the COVID-19 public health emergency, EndeavorRx received its De Novo clearance in June last year.
IN CONCLUSION
"The new digital therapeutic described in this paper is not intended to replace existing and efficacious approaches for managing ADHD," Kollins wrote in a viewpoint article accompanying the data in npj Digital Medicine. "However, for the first time in decades, a completely novel, efficacious and safe modality of treatment is available as an option for patients, and has passed the scrutiny of regulators to ensure a favorable benefit:risk ratio.

"As is often the case with the introduction of innovative solutions to old problems, there will be skepticism, including misinformed and mischaracterized criticism of the innovation itself or the studies that support its use. But at the end of the day, having more empirically-supported treatment options is an important step for the field; and hopefully one that can represent a sea change to usher in a new era of new tools to manage ADHD and many other conditions," he wrote.

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Full results of EndeavorRx adjunct trial show longer benefits with or without stimulant therapy

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Akili Interactive has published the full data from its STARS-ADHD Adjunctive trial. The data builds upon the company's pivotal study of AKL-T01 (now available as EndeavorRx) and suggests the videogame-like digital therapeutic delivers benefits with or without accompanying stimulant medication, and that they persist up to one month following the treatment.

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EndeavorRX is a digital game application created by a team of neuroscientist and game designers that can be played on iphones, androids, and tablets. The purpose of the game is to help improve symptoms of ADHD. It is for children ages 8-12. The game grows more difficult as a child's attention improves. It can be obtained through a written prescription through a healthcare provider (Muoio, 2021).

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Today, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD). The prescription-only game-based device, called EndeavorRx, is indicated for pediatric patients ages 8 to12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. EndeavorRx is indicated to improve attention function as measured by computer-based testing and is the first digital therapeutic intended to improve symptoms associated with ADHD, as well as the first game-based therapeutic granted marketing authorization by the FDA for any type of condition. The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.

"The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics."

ADHD is a common disorder that begins in childhood, affecting approximately 4 million children ages 6-11. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and very high levels of activity. According to the Centers for Disease Control and Prevention, diagnosis of ADHD should be conducted by a trained health care professional and follow an evaluation of symptoms or pattern of symptoms, such as inattention, hyperactivity, and impulsivity that interfere with functioning or development.

The FDA reviewed data from multiple studies in more than 600 children, including studies that evaluated, among other things, whether participants demonstrated improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools. There were no serious adverse events reported. The most common adverse events observed with EndeavorRx are: frustration, headache, dizziness, emotional reaction, and aggression.

The FDA reviewed the EndeavorRx through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization for the EndeavorRx to Akili Interactive.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Related Information

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FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD

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Today, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD). The prescription-only game-based device, called EndeavorRx, is indicated for pediatric patients ages 8 to12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue.

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This seems like a good option for families to try if they are trying to avoid giving their children medications for ADHD, although it can be given as a adjuvant. I do believe more studies need to be done to verify the effectiveness. Each family will need to weigh the pros and cons for themselves to determine if it is a good option for their child.

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Responsibility: (Executing) Takes ownership in commitments made. Value honesty and loyalty.
Connectedness: (Relationship building) Believes all things are connected, there is a reason behind things that happen, and there are few coincidences.
Context: (Strategic thinking) Views the present through their understanding of the past and enjoys learning about the past.
Harmony:(Relationship building) Likes to focus on what we have in common instead of our differences. Good at building strong relationships that hold a team together.
Belief: (Executing) Strong core values that do not change and provide purpose for life.

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Fernando: Focus. Good at follow through and staying on track.
Matthew: Maximizer. Finds and focuses on strengths to build a team up to excellence.
Sheila: Strategic. Good at planning and finding ways to reach goals.
Andrew: Activator. Action oriented. Likes to makes things happen.
Angelica: Analytical. Thinks about factors of causes and effects.

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1. A nonpharmaceutical treatment option for children with ADHD.
2. Minimal transient side effects reported (Muoio, 2021).

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1. Involves more screen time for children who may already spend too much time on electronics.
2. Not for children with predominately hyperactive- impulsive type ADHD, a seizure disorder or color blind (Aungst & Murdock, 2021).
3. Not all insurances cover it. Without insurance it will cost about $100 per month. Each subscription is in 3 month increments (Aungst & Murdock, 2021).

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Aungst, C. & Murdock, J. (2021). What is EndeavorRx, the video game for ADHD. GoodRx.com.
Muoio,D. (2021). Full results of EndeavorRx adjunct trial show longer benefits with or without stimulant therapy. Mobihealthnews.com.