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Akili Interactive announced Thursday that its digital therapeutic AKL-T03 demonstrated a significant improvement in sustained attention compared to control as a treatment for cognitive impairments adjunct to antidepressant medication in adults with major depressive disorder (MDD). Results from the study were presented at the American College of Neuropsychopharmacology (ACNP) annual meeting.
The trial randomised over 80 adults diagnosed with mild-to-moderate MDD symptoms and with mild-to-moderate cognitive impairment to receive treatment with AKL-T03, which is a video game-based digital therapeutic, or control, which consisted of a video game designed with similar reward and engagement as AKL-T03. Akili noted that both groups used the treatment at home on a tablet device for 25 minutes a day, five days per week, over a six-week period. After the treatment period, an in-clinic evaluation was conducted with the primary outcome assessing sustained attention as determined by the Test of Variables of Attention (T.O.V.A), an FDA-cleared objective measure of attention.
According to Akili, AKL-T03 uses the company's SSME technology engine, which deploys sensory and motor stimuli to target and activate the fronto-parietal network in the brain. CEO Eddie Martucci remarked "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."
Results showed that AKL-T03 significantly improved patients' sustained attention as compared to the control, which did not show an improvement. Akili added that engagement with AKL-T03 was also shown to be associated with improved processing speed, or the time required to complete a specific task.
Richard Keefe, the study's primary investigator, said "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."
In 2017, Akili announced results of the STARS-ADHD trial showing that its investigational digital medicine, AKL-T01, showed an improvement in attention in children and adolescents with paediatric attention-deficit hyperactivity disorder. AKL-T01 is currently under review by the FDA, while Akili has partnered with Shionogi on the digital therapeutic in Japan and Taiwan.
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