Attention Therapeutics Release: ATENTIVmynd Games Lead To Significant And Sustained Reductions In Core Symptoms Of Attention Deficit Hyperactivity Disorder And Improved Academic Performance

WALTHAM, Mass.--(BUSINESS WIRE)--Attention Therapeutics LLC, a wholly owned subsidiary of Atentiv LLC and developer of digital health products, announced the results of a randomized, controlled and parallel human phase II clinical trial, which demonstrated that a novel nonpharmacological intervention, ATENTIVmynd™ Game training, resulted in significant and sustained reduction in the core symptoms of Attention Deficit/Hyperactivity Disorder (ADHD) in children aged 8-12, along with significant improvement in academic performance.

“I have been waiting 30 years for such a solution for children and parents. The profession needs to provide a parent with an effective, sustainable treatment option. Every parent wants significantly improved academic performance and home behavior. Kids love to play by using their attention levels to control game outcomes.”

The study, available online ahead of print in the peer-reviewed Journal of Attention Disorders (http://jad.sagepub.com) appeared under On Line First. Highlights of the study include:

• Participants who received the ATENTIVmynd™ Game training showed statistically significant improvements in ADHD symptomology and academic performance while the control group did not show meaningful improvement;
• Improvements from the ATENTIVmynd™ Game were sustained at follow-up three months later;
• Participants in the control group who completed the standard nonpharmacological community care intervention after 8 weeks, were then crossed over and trained over 8 weeks with the ATENTIVmynd™ Game intervention. Pooled results demonstrated that both groups experienced the same degree of statistically significant behavioral and academic performance improvements as measured by the parent and clinician rated ADHD-RS and PERMP when compared to baseline;
• ATENTIVmynd™ Game appears to be an effective intervention, which leads to sustained reductions in the core symptoms of ADHD (inattention, impulsivity and hyperactivity) while significantly improving a child’s underlying cognitive skills that strengthen academic performance.

As a result, Attention Therapeutics LLC plans to start a large double-blind, randomized and controlled study to further evaluate its ATENTIVmynd™ Game in 2016. If the results are positive, that data could support FDA clearance of the first nonpharmacological treatment of ADHD associated with significant and sustained reductions in the major symptomology of ADHD and improved academic performance.

Eric Gordon, Attention Therapeutics LLC CEO and Founder stated: “Millions of children diagnosed with ADHD may soon have access to an effective digital therapeutic that could help to remediate ADHD by a simple, engaging and rapid training of the vital cognitive skills of attention and impulse control, through which newly learned skills quickly become a routine of everyday life. Parents searching for significant improvements in academic performance and home behavior with sustained duration, may soon have access to this novel non-pharmacological therapeutic.”

Ranga Krishnan, MD Psychiatrist, Scientific Founder, Dean of Rush Medical College and former Dean of the Duke – National University of Singapore Graduate School of Medicine stated: “ADHD is one of many neuro-circuit disorders. Neuroplasticity-based treatments, such as ATENTIVmynd™ Games, will be an important part of Integrated Practices in neurological and psychiatric medicine.”

Ned Hallowell, MD Ed D Child and Adult Psychiatrist stated: “I have been waiting 30 years for such a solution for children and parents. The profession needs to provide a parent with an effective, sustainable treatment option. Every parent wants significantly improved academic performance and home behavior. Kids love to play by using their attention levels to control game outcomes.”

John Ratey, MD, Psychiatrist, Clinical Associate Professor of Psychiatry at Harvard Medical School, stated: “When I became acquainted with Atentiv I was skeptical as so many other treatments have come and gone. When I studied their results however, I saw the data supported the efficacy and sustainability. The fact that this seems to be an eight hour treatment that is fun and engaging and now looks like it lasts at least several months when treatment stops, gives us great hope for a real alternative for treating ADHD.”

Andrew Krystal, MD Psychiatrist, Director of Neurosciences Medicine for the Duke Clinical Research Institute stated: “We increasingly understand the mechanisms by which behaviors can activate the neuromodulators that play a role in the brain changes that underlie cognitive skill learning. ATENTIVmynd™ Game training appears to effectively engage these mechanisms and lead to significant and sustained improvement in ADHD symptoms and functional capacity.”

Tony Wagner, Ed D Harvard New Innovation Lab stated: “We have never taught these cognitive skills in our schools. Core cognitive component skills applications can then be followed by composite skill training to achieve higher cognitive skill level sets such as in self-regulation. Simplicity, practicality, cost, speed and significant increased academic achievement in the classroom are likely to drive broad adoption.”

Study Details: In this phase II study, 40 un-medicated children with mild to moderately severe ADHD were randomized (1:1) into either ATENTIVmynd™ Game training or a standard nonpharmacological community care control group. All participants in the new therapy group completed 8 hours of training, comprising three 20 minute sessions per week, or one hour per week, for eight weeks. All participants in the new therapy group were then followed for three months with no training and reassessed on all measures. Results for the original ATENTIVmynd™ Game training group and the crossed-over control group subsequently trained with the ATENTIVmynd™ Game were then pooled. ADHD symptoms were measured by clinicians and parents on the ADHD Rating Scale (ADHD – RS). The ADHD-RS is the standard test for diagnosing ADHD in children and adolescents and assessing their response to treatment. The 18 item scale is based on the ADHD diagnostic criteria as defined in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. The ATENTIVmynd™ Game training group demonstrated significant improvements in ADHD symptoms compared to the control group (P<0.001) after 8 weeks or approximately 8 hours of training. Average reductions in ADHD-RS scores were 36 percent as assessed by clinicians and 31 percent by parents. These reductions were maintained for three months after eight weeks of training.

The study demonstrated that children’s academic productivity significantly improved with training compared to the control as measured by the Permanent Product Measure of Performance (PERMP) test, an ability-adjusted collection of math problems that provides an accurate and objective measure of a child’s ability to pay attention and stay on task based on the number of correctly completed math problems. The training group improved the number of questions they answered correctly from 76.3 on average at baseline to 103.3 questions after training (35% average improvement), which was significantly more improvement (P<.05) than the control group with 77.4 correct answers at baseline and 76.5 after eight week community care intervention. The improvements seen in the training group were sustained at the three month follow-up assessment. Pooled results demonstrated that both groups experienced the same degree of significant academic productivity improvements as measured by the PERMP. The only adverse event experienced was headache, occasionally occurring in the first few training sessions (less than 2% of training sessions) with immediate resolution thereafter.

The authors noted that these results are consistent with five other clinic, school, and home studies using ATENTIVmynd™ Games in over 180 ADHD children.

About ATENTIVmynd™ Games: ATENTIVmynd™ Games are a digital therapeutics product platform that uses proprietary feedforward modeling technologies that measure and increase focused attention to activate the neuromodulators of learning. Each ATENTIVmynd™ Game is a series of adventures in a virtual world where children are challenged with multiple tasks over four to eight weeks to learn the multiple cognitive skills of attention and impulse inhibition. Because performance varies based on each individual’s learning pace, each game will take about eight hours to complete over approximately 24 training sessions. An AV™ Headset is used to capture EEG signals and send via wireless communication to any Bluetooth© enabled device to engage with a downloaded customized product application from the company’s servers. ATENTIVmynd™ Games for the treatment of ADHD are not available for sale in the United States. FDA review will be required before the product can be commercially introduced for use by medical professionals.

About ADHD: Attention Deficit Hyperactivity Disorder affects about 11% of children. The core observable symptoms are inattention, impulsivity and hyperactivity. It is a complex condition involving several interconnected brain regions and impacts all other executive functions, including memory, abstract reasoning, critical thinking and decision making. Causes of ADHD include both genetic and environmental components. Current treatment approaches for ADHD include modification of neurotransmitter levels (medication), psychosocial interventions (behavioral therapy, parent training and academic accommodations), working memory training and neurofeedback. The dilemma faced by anyone struggling with ADHD is that all of these treatments are only partially effective at alleviating some of the symptoms. However, none of these interventions teach the critical underlying cognitive skills to achieve sustained normal levels of attention and impulse control and academic achievement.

About Attention Therapeutics LLC- Attention Therapeutics LLC (ATL) is a wholly owned subsidiary of Atentiv LLC. ATL develops and intends to manufacture and market a variety of digital health products exclusively for medical professionals to help diagnose and treat mental illnesses, beginning with ADHD. Atentiv LLC develops and intends to manufacture and market a variety of digital education products exclusively for consumer and education markets. For additional information please visit www.attentiontherapeutics.com