Attention Deficit/Hyperactivity Disorder (ADHD)
Our lead candidate, AKL-T01, is an investigational digital medicine being evaluated as a potential prescription treatment for children with ADHD. AKL-T01 is currently under regulatory review to ensure it meets strict standards for efficacy, safety, and manufacturing before being prescribed by physicians.
AKL-T01 is designed to deploy sensory and motor stimuli to target and activate the prefrontal cortex, the area of the brain known to play a key role in cognitive function.
Building on multiple published clinical trials, a multi-center, randomized, double-blind, active-controlled pivotal study of AKL-T01 in pediatric ADHD has recently been completed. This is the first study of its kind, evaluating a potential new digital medicine as you would a drug to treat disease. If cleared by FDA, physicians will be able to prescribe AKL-T01 to treat ADHD patients just as they currently prescribe drugs.
Autism Spectrum Disorder (ASD)
We are evaluating AKL-T02 as a potential digital treatment for attention symptoms in children with autism spectrum disorder. Building on the specific and simultaneous sensory and motor stimuli of AKL-T01,we have worked with experts and the ASD community to design AKL-T02 to specifically address the needs of ASD patients.
AKL-T02 has been tested in a small, active-controlled study with ASD patients who also have significant attention issues. This feasibility study evaluated the impact of the digital treatment on attention abilities and parent reported behavioral symptoms of attention and executive function.
Major Depressive Disorder (MDD)
We are currently evaluating two investigational products, AKL-T03 and AKL-T04, as potential prescription digital medicines for the treatment of cognitive deficiency in adult patients with Major Depressive Disorder. AKL-T03, currently in Phase II clinical studies, targets executive function abilities such as attention and working memory. AKL-T04, currently in feasibility phase, targets both executive function abilities and emotional processing capabilities.
In creating AKL-T03 and AKL-T04, we have completely redesigned the sensory and motor stimuli that target the prefontal cortex to provide a treatment course that is suitable for adults. In addition, working with experts in cognition and emotional processing in depression, we have created new stimuli designed to strengthen the link between the prefrontal cortex and areas of the brain that interpret and process emotion. These changes, being tested in AKL-T04, may more specifically target emotional processing and mood symptoms in addition to improving executive function abilities.
Multiple Sclerosis (MS)
AKL-T03 is being evaluated as a potential digital medicine to address cognitive impairment in patients with multiple sclerosis. Building on a successful open-label feasibility study, AKL-T03 is currently being clinically tested through a randomized controlled pilot study.
AKL-T03 is engineered to target pre-frontal cortex based cognitive functions such as complex attention, executive functions, and information processing speed. AKL-T03 is being developed in association with AKL-M01, a cognitive monitor being evaluated as a possible clinical assessment technique for the evaluation and the remote monitoring of cognitive impairments at-home or for in-patient settings.
We're actively exploring the potential of our technologies to help people living with cognitive dysfunction associated with numerous other medical conditions. We currently have ongoing clinical trials in traumatic brain injury (TBI), ICU delirium, lupus, and more. Stay tuned.
If you’d like to learn more about any of our clinical trials underway, please visit clinical trials.gov. If you would like to explore a potential clinical trial collaboration, please contact us. We’d love to hear from you