New digital therapy significantly improves sustained attention among patients with depression

According to a new study, treatment with digital therapy AKL-T03 significantly improved sustained attention amongst patients with depression compared to control.

AKL-T03 is a digital therapy that works by activating the brain's fronto-parietal networks to increase attention and related attentional control processes.

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.

"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.

Reference:

1. Keefe RSE, McClintock SM, Roth RM, Doraiswamy PM, Tiger S, Madhoo M: Cognitive effects of pharmacotherapy for major depressive disorder: A systematic review. J Clin Psychiatry 2014; 75(8): 864-876. https://doi.org/10.4088/jcp.13r08609

2. Knight MJ, Mills NT, Baune BT: Contemporary methods of improving cognitive dysfunction in clinical depression. Expert Rev Neurother 2019; 19(5):431-443. https://doi.org/10.1080/14737175.2019.1610395

3. McIntyre R, Harrison J, Loft H, Jacobson W, Olsen CK: The effects of vortioxetine on cognitive function in patients with major depressive disorder: A meta-analysis of three randomized controlled trials. Int J Neuropsychopharmacol 2016; 19(10):pyw055. https://doi.org/10.1093/ijnp/pyw055

4. Gonda X, Pompili M, Serafini G, Carvalho A, Rihmer Z, Dome P: The role of cognitive dysfunction in the symptoms and remission from depression. Ann Gen Psychiatry 2015; 14:27. https://doi.org/10.1186/s12991-015-0068-9