PureTech Founded Entity Akili Announces American Journal of Psychiatry Publication of Data Demonstrating its Digital Therapeutic AKL-T03 Improves Cognitive Impairments in Adults w/ Major Depressive Disorder When Combined w/ Antidepressant Medication
PureTech Health announced that Akili’s AKL-T03 digital therapeutic demonstrated a statistically significant improvement in sustained attention in adults with major depressive disorder (MDD) when combined with antidepressant therapy, as published in the American Journal of Psychiatry. The STARS-MDD trial involved 80 adults and showed a 0.005 significance level. This digital therapeutic builds on the technology of EndeavorRx, already FDA-cleared for treating children with ADHD. Akili aims to fill a gap in treating cognitive impairments associated with depression, a condition affecting over 16 million Americans.
- AKL-T03 demonstrated statistically significant improvement (p=0.005) in sustained attention for adults with MDD.
- The digital therapeutic is based on the same technology as EndeavorRx, which is FDA-cleared for ADHD treatment.
- The study addresses cognitive impairments in a patient population where typical antidepressants have limited effectiveness.
- No serious adverse events were reported, with only 5.5% of patients experiencing headaches.
- None.
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
More than 16 million people in
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.
The full text of the announcement from Akili is as follows:
The
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
More than 16 million people in
“Society is facing a growing mental health crisis, with depression rates in the
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 (
“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
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 (
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
For more information, please visit www.akiliinteractive.com.
Additional Information and Where to Find It
In connection with the proposed business combination transaction between
The documents filed by SCS with the
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SCS and Akili and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from SCS’s shareholders in connection with the proposed transaction. A list of the names of such directors and executive officers and information regarding their interests in the proposed transaction between Akili and SCS are contained in the proxy statement/prospectus. You may obtain free copies of these documents as described in the preceding paragraph.
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This communication shall not constitute a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction. This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any states or jurisdictions in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act or an exemption therefrom. This press release may be deemed to be solicitation material in respect of the proposed transactions contemplated by the proposed business combination between Akili and SCS.
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For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation those statements that relate to AKL-T03, Akili’s SSMETM technology engine, expectations around EndeavorRx, the proposed business combination agreement between
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