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HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATAPrimary Endpoint Achieved in Randomized, Controlled Trial of Digital Therapeutic AKL-T03 in...

Primary Endpoint Achieved in Randomized, Controlled Trial of Digital Therapeutic AKL-T03 in Major Depressive Disorder

Akili Interactive (“Akili” or “Company”), today announced results of its randomized, controlled study of digital therapeutic AKL-T03 as a treatment for cognitive impairments adjunct to anti-depressant medication in adults with MDD. AKL-T03 demonstrated a statistically significant improvement in sustained attention compared to control. Results of the study were presented yesterday at the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP).

Cognitive impairment is a fundamental diagnostic criterion of depression, and the majority of people living with MDD experience substantial cognitive issues, including with attention, decision-making and processing speed. Such cognitive impairments have been shown to be a predictor of daily function. More than 16 million people are living with MDD, and a majority have cognitive deficits on neuropsychological tests and/or self-report cognitive issues, yet their options for treatment are limited.

“The majority of patients with MDD experience cognitive impairments, significantly impacting their day-to-day function and quality of life as well as in their risk of recurrence of depression. These impairments are as important to treat as the classical depressive symptoms and, for many patients, persist even after successful antidepressant treatment,” said Richard Keefe, PhD, Professor of Psychiatry at Duke University Medical Center and primary investigator of the study. “Based on the results of this study, when combined with antidepressants, AKL-T03 potentially represents a low-risk treatment option that appears to improve cognitive impairments in MDD where few options are available for patients today.”

AKL-T03 is designed to improve specific cognitive functions and may play a complementary role to antidepressants in the holistic treatment of MDD. AKL-T03 was built on Akili’s SSME technology engine, which deploys sensory and motor stimuli to target and activate the fronto-parietal network in the brain, known to play a key role in cognitive function. The treatment is delivered through a captivating action video game to drive enjoyment and compliance.

“We believe cognitive issues represent one of the major unmet medical needs of the next decade and have a debilitating effect on the lives of millions of people, both with and without medical diagnoses,” said Eddie Martucci, CEO of Akili Interactive. “We’re very encouraged by the results of our study of AKL-T03, which add to our growing body of data on our SSME technology engine’s ability to improve cognitive impairments across a number of populations in need.”

In the study, AKL-T03 showed a statistically significant improvement in sustained attention compared to control (p=0.002) on the predefined primary endpoint, as measured by the Test of Variables of Attention (T.O.V.A.®), an FDA-cleared objective measure of attention. Engagement with AKL-T03 also showed a strong correlation with improved processing speed. AKL-T03 was shown to be safe in this study, with no serious adverse events observed. Results of the study will be submitted for publication in a peer-reviewed journal.

For Patients
In this study, the potential digital treatment, AKL-T03, was compared to a non-therapeutic product (the control) to evaluate AKL-T03’s safety and ability to improve certain cognitive impairments and, specifically, sustained attention, which is ability to focus on an activity over a long period of time. The study showed that AKL-T03 significantly improved patients’ sustained attention as compared to the control which did not show an improvement. Engagement with AKL-T03 was also shown to be associated with improved processing speed, or the time required to complete a specific task. At this time, AKL-T03 is not yet available for patient use outside of clinical studies.

Study Design
The study was a multi-center, randomized, controlled trial of AKL-T03 in over 80 adult participants diagnosed with mild-to-moderate MDD symptoms and with mild-to-moderate cognitive impairment. All participants were on stable antidepressant medication. Participants were randomized 1:1 to AKL-T03 (video game-based digital therapeutic) or a control (video game designed with similar reward and engagement of AKL-T03). Both groups used the treatment/control at home, 5 days per week for 25 minutes per day, on a tablet device for six weeks. Following the treatment period, an in-clinic assessment was conducted to assess key outcomes. The primary outcome of the study assessed sustained attention as measured by Test of Variables of Attention (T.O.V.A.®). The study was managed by VeraSci.


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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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