ADHD - Attention Deficit/Hyperactivity Disorder

Akili’s lead candidate, AKL-T01, is being evaluated as a potential prescription digital medicine for the treatment of children with ADHD. AKL-T01 is in the final phase of development, advancing through the regulatory process to ensure it meets the strict FDA standards for efficacy, safety, and manufacturing, like prescription drugs must meet before being prescribed by physicians.

AKL-T01  is designed to therapeutically treat cognitive deficiency and improve related symptoms with specific sensory stimuli and simultaneous assessment of motor responses to  target and activate the prefrontal cortex.In clinical studies to date, AKL-T01 was shown to improve attention, inhibition and working memory in children with ADHD.

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 pharmaceuticals. 

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ASD - Autism Spectrum Disorder

Akili plans to expand its pediatric behavioral medicine product line by 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, Akili has worked with experts & the ASD community to design AKL-T02 to be targeted specifically to the needs of ASD patients.

AKL-T02 was 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.

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MDD - Major Depressive Disorder

Akili is currently evaluating two candidates, 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.  Akili has developed preliminary evidence of the ability to improve cognition in a small, active-controlled, feasibility study in a depressed older adult population and continues to build and expand on that work with clinical studies in adults of a wider age range.

In creating AKL-T03 and AKL-T04, Akili has completely redesigned the sensory and motor stimulus that target the prefontal cortex to provide a six-week treatment course that is suitable for adults.   In addition, working with experts in cognition and emotional processing in depression, Akili has 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.

Upon successful completion of both Phase II and pivotal clinical trials, Akili will submit the products to FDA for clearance as prescription medical devices. 

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MS - Multiple Sclerosis

AKL-T05 is being evaluated as a potential candidate for the treatment of cognitive impairments for patients with Multiple Sclerosis. AKL-T05 recently transitioned into an advanced active-control pilot phase.

AKL-T05 is designed to identify impaired cognitive functions and adapts the nature of the therapeutic intervention to the pre-identified cognitive deficiencies. AKL-T05 targets pre-frontal cortex based cognitive functions such as complex attention, executive functions, and information processing speed.

AKL-T05 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 in any in-patient settings. The development AKL-M01 will comply with all regulatory requirements applicable to any clinical assessment systems and will be compared to all standard testing for cognitive functions applicable to Multiple Sclerosis. If developed successfully, this monitor would provide to physicians the ability to establish a cognitive performances baseline and would enable patients to monitor and report the evolution of their cognitive impairments or other symptoms associated to Multiple Sclerosis on a noninvasive, high frequency and clinically relevant way.

 

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Other Indications

We're committed to exploring the potential of our technologies in various patient populations that experience debilitating cognitive dysfunction.  We currently have ongoing clinical trial work in Parkinson's disease, Traumatic Brain Injury (TBI), ICU delirium, and more.  To get in touch for a clinical trial collaboration, please contact us for more information.

 

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