Leading digital medicine company Akili, has announced results from a pivotal clinical trial, evaluating the efficacy and safety of EndeavourRx, in adults with attention-deficit/hyperactivity disorder (ADHD).
The trial, STARS-ADHD-Adult, was a multi-center open-label study, which recruited 221 adults with inattentive or combined-type ADHD. Participants used the EndeavorRx program at home on a mobile device for 6 weeks. Users' attention levels were evaluated before and after the study period using the Test of Variables of Attention (TOVA) Attention Comparison Score (ACS). After six weeks the change from the baseline was almost 6.5 points, higher than the 2.6 point improvement seen in adolescents and 0.9 point improvement seen in 8-12 year old's. Akili noted that results were consistent across patients taking medication and those who weren’t.
Alongside improved attention, study participants also saw significant improvements in their ADHD symptoms, by at least 30%. Again surpassing findings in the STARS-ADHD-Adolescents study in 13-17 year old's with ADHD (27.1%) and the STARS-ADHD study in 8-12 year old's with ADHD (24%).
More than 70% also reported improvements in their quality of life as measured by the validated Adult ADHD Quality of Life Scale (AAQoL) and almost half met the criteria for clinically meaningful improvements.
No serious adverse effects were reported by participants, however, some reported nausea and headache.
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