American Journal of Psychiatry Publishes Data Demonstrating Akili's Digital Therapeutic AKL-T03 Improves Cognition in Adults with Major Depressive Disorder When Combined with Antidepressant Medication
AKL-T03 showed a statistically significant improvement in sustained attention compared to control intervention
AKL-T03 is built on the same technology engine as Akili’s digital therapeutic EndeavorRx, which has been cleared by the U.S. Food and Drug Administration (FDA) for use in children with ADHD (see full indication below)
BOSTON, Mass – April 12, 2022 – Akili Interactive (“Akili”), a leading cognitive medicine company improving health through game-changing technologies, today announced that the American Journal of Psychiatry has published findings from the STARS-MDD clinical trial evaluating Akili’s AKL-T03 digital therapeutic as a potential treatment for attention impairments in adults with major depressive disorder (MDD) when used alongside antidepressant medication.
More than 16 million people in the United States are living with MDD.1 Despite the positive benefits of antidepressant therapy on mood, most pharmacologic treatments provide little or no benefit on cognitive impairments in patients with MDD.234 Many patients with MDD who have responded to antidepressant treatment continue to report cognitive challenges, including difficulties concentrating, decision making, slowed thinking, and forgetfulness, which have been shown to have an impact on daily activities, like education and work.⁵
“Society is facing a growing mental health crisis, with depression rates in the U.S. increasing about 20% during the pandemic. While mood symptoms are most often associated with MDD, equally concerning are the frequent associated cognitive impairments,” said Richard Keefe, Ph.D., Professor of Psychiatry at Duke University Medical Center, and primary investigator of the study. “More than ever, we need safe and effective ways to support these patients – new tools that can be easily and broadly accessed. Based on the results of this study, AKL-T03 has the potential to play a meaningful role in the treatment of MDD patients.”
The STARS-MDD study enrolled 80 adults, ages 25-55, who were stably treated with an antidepressant medication yet were still experiencing mild to moderate symptoms of depression as well as cognitive impairments. Patients were randomized 1:1 to AKL-T03 or a digital control designed to have an equal expectation of benefit. Results of the study demonstrated that the addition of AKL-T03 to antidepressant therapy significantly improved sustained attention in adults diagnosed with MDD compared to the control (p=0.005), as measured by the Test of Variables of Attention (TOVA), which is a computerized test cleared by FDA to assess attention deficits and evaluate the effects of interventions in ADHD.
No treatment-related serious adverse events were reported, and two patients (5.5%) reported headaches following treatment with AKL-T03. Results from the STARS-MDD study were first presented at the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) and are consistent with those of prior research of Akili’s study of AKL-T01 in patients with MDD, published in Translational Psychiatry.⁶
“Addressing cognitive impairments associated with depression has been an area of interest from healthcare professionals and companies over recent years, yet options remain limited for patients,” said Anil S. Jina M.D., Chief Medical Officer of Akili. “Akili’s technology is designed to target specific neural networks related to attention function and this study demonstrates the important role it could play in the treatment of patients with cognitive dysfunction in depression.”
AKL-T03 is an investigational medical device which has not been cleared by FDA. It is built on Akili’s SSMETM technology engine, which is designed to address impairments in attention independent of disease. SSME presents specific sensory stimuli and simultaneous motor challenges designed to target the fronto-parietal cortex, an area of the brain which plays a key role in attention function. This is the same technology embedded in AKL-T01, which has been branded as EndeavorRx® and cleared by FDA to treat attention symptoms in children ages 8-12 diagnosed with ADHD (see full indication below). AKL-T03 was adapted from AKL-T01 with a new game interface designed specifically for an adult patient population.
About STARS-MDD
The Software Treatment for Actively Reducing the Severity of Cognitive Deficits in Major Depressive Disorder (STARS-MDD) study (NCT03310281) is a randomized, double-blind, controlled study designed to assess the safety and efficacy of AKL-T03 versus an expectation-matched digital control intervention in an at-home setting. The study enrolled 80 adult patients between the ages of 25 and 55 with a confirmed diagnosis of MDD according to DSM-5 criteria and confirmed via the Mini International Neuropsychiatric Interview, version 7.0.2. Other key inclusion criteria included confirmation of a score between 14 and 22 on the 17-item Hamilton Depression Rating Scale (HAM-D) during the screening phase (day -28) and at baseline (day 0) and a symbol coding T-score < 50 on the Brief Assessment of Cognition. Participants were required to have been on antidepressant medication for > 8 weeks prior to screening/baseline with a stable dosage for > 4 weeks prior to baseline. Patients were randomized 1:1 to AKL-T03 or a digital control, both of which were administered using Apple iPad mini 2 tablets. Participants in the AKL-T03 arm were instructed to complete five sessions, at least five days per week for six weeks, for a total of approximately 25 minutes of game-play per day. The software automatically locked after the five sessions were completed, to preclude excessive use of the intervention. Participants assigned to the control arm also were instructed to complete 25 minutes of game-play for at least five days per week for six weeks; this software also automatically locked after 25 minutes. The primary endpoint was a change from baseline in cognitive performance following AKL-T03 intervention compared with the control group, as measured by change in sustained attention using the TOVA reaction time to rare target stimuli, normalized by age and sex. The TOVA is a validated computerized continuous performance test of attention and inhibitory control. Change from baseline scores from the first half of the TOVA between day 0 (baseline) and day 42 (study exit) was compared between the two intervention groups.
EndeavorRx® Indication and Overview
EndeavorRx® is indicated to improve attention function as measured by computer-based testing in children ages 8 to 12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx® demonstrate improvements in a digitally assessed measure Test of Variables of Attention (TOVA®) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx® should be considered 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. EndeavorRx® is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication. EndeavorRx associated adverse events in clinical trials included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). No serious adverse events were associated with its use. EndeavorRx® is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider. To learn more about EndeavorRx®, please visit EndeavorRx.com.
About Akili
Akili is pioneering the development of cognitive treatments through game-changing technologies. Our approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device, but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences.
On January 26, 2022, Akili entered into a definitive agreement to become publicly traded via a merger with Social Capital Suvretta Holdings Corp. I (Nasdaq: DNAA), a special purpose acquisition company. The transaction is expected to close in mid-2022, subject to satisfaction of the closing conditions, after which Akili will be listed on the Nasdaq stock market under the new ticker symbol “AKLI.”
For more information, please visit www.akiliinteractive.com.
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¹ Anxiety and Depression Association of America
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