Cognitive Interference Processing

(AKLT, AKLS, AKLM)

Brain / Nervous System

TRIAL PHASE
MECHANISMINDICATION(S)PRODUCT NAMEPreclinicalPhase 1Phase 2Phase 3
Cognitive Interference Processing
Pediatric ADHD, Alzheimer's Disease, Depression
Akili
(AKLT, AKLS, AKLM)

Brain / Nervous System

Cognitive Interference Processing
INDICATION(S):Pediatric ADHD, Alzheimer's Disease, Depression
NAME:Akili (AKLT, AKLS, AKLM)
STAGE:Phase 3
Cognitive therapeutics, assessments, and diagnostics

We are building clinically-validated cognitive therapeutics, assessments, and diagnostics that look and feel like high-quality video games. Our aim is to develop a new type of digital medicine that can be deployed remotely and directly to any patient anywhere, prescribed and tracked by physicians. We are currently conducting multiple clinical trials of our digital medicine platform across a variety of patient populations, including pediatric ADHD, autism spectrum disorder (in collaboration with Autism Speaks), depression, Alzheimer’s disease and traumatic brain injury. Our lead product candidate, Project: EVOTM, is currently being evaluated in a pivotal trial in patients with pediatric ADHD. 

  • Patient Need & Market Potential
    • There are a number of conditions where the brain’s executive function is negatively impacted, including ADHD, autism, Alzheimer’s disease, and depression. The markets for treatment of these conditions all have significant needs in terms of risk-benefit profiles, and are currently only partially served by centrally-acting drugs with challenging safety profiles or by in-person behavioral therapy
    • The market for ADHD therapeutics is projected to be approximately $10 billion by 2020 and we believe that this market – and the other markets in which our Cognitive Interference Processing products may act as a stand-alone medical treatment, add-on therapy, or digital biomarker – represent significant opportunities for the program
  • Our Approach to Solving the Problem
    • Our technology is non-invasive and built to be patient-friendly, while designed to have a potent treatment effect
    • By leveraging medical-grade science and consumer-grade software technology, we are seeking to produce a new type of medical product that can offer safe and effective scalable treatment and better monitoring for patients across a range of mental health and neurological conditions
  • Intellectual Property
    • We currently own or have exclusive rights to a total of 25 issued patents and patent applications in 13 families or patent filings
    • One of these 13 families of IP is exclusively licensed from UCSF and covers our cognitive assessment and treatment methods related to interference processing.
  • Team
    • Our cross-disciplinary team has expertise in neuroscience, clinical trials in related disorders, video game design, data science, and consumer engagement
    • Key Advisors include:

      Dr. Adam Gazzaley, the Founding Director of Neuroscape Lab at UCSF;

      Dr. Daphne Bavelier, Professor of Cognitive Neuroscience at the University of Geneva, and of Brain and Cognitive Sciences at the University of Rochester;

      Dr. Stephen Faraone, Professor in the Departments of Psychiatry and Neuroscience & Physiology at SUNY Upstate Medical University and Director of Medical Genetics Research for the University;

      Dr. Robert Schultz, Professor of Psychology in the Department of Pediatrics at the University of Pennsylvania School of Medicine; and

      Dr. Geraldine Dawson, Professor, Departments of Psychiatry and Behavioral Sciences, Pediatrics, and Psychology, and Neuroscience and Director of the Duke Center for Autism and Brain Development at Duke University

    • The program was developed and is run by Dr. Eddie Martucci and team members, Mr. Matthew Omernick, Mr. LeRoux Jooste, and Mr. Scott Kellogg
  • Milestones Achieved
    • Proof-of-concept treatment data on our Cognitive Interference Processing technology was established as the cover story in the top tier medical science journal, Nature Medicine (link to publications at the bottom of the page)
    • An open-label pilot study in 80 children confirmed that Project: EVO improved attention, inhibition, and working memory – including both objective measures and subjective parent-reported systems – in children with ADHD
    • In collaboration with Pfizer, we presented data at the International Conference on Clinical Trials for Alzheimer’s (CTAD) showing that the our Cognitive Interference Processing technology differentiated between older healthy subjects positive for amyloid deposits in their brains (a primary biomarker for Alzheimer’s risk) vs. an age-matched comparison group of amyloid-negative subjects, both in change over time (p=0.04) and at the completion visit after a 28-day remote self-administration protocol (p<0.008)
    • Academic investigators recently published two pilot research studies in peer-reviewed journals showing the potential benefit of our core cognitive treatment technology in targeting cognition and mood in depressed individuals (link to publications at bottom of page)
    • Our cognitive interference targeting technology has also been further studied, with additional efficacy data and symptom benefit, in a group of children with sensory processing and attention impairments. Published in April, this open-label study builds on a series of announcements and publications since December 2016 (Alzheimer’s disease, late life depression, depression and sensory processing dysfunction), which together support the advancement of three major product programs based on our platform technology: treatments, screens, and monitors 
  • Collaborations
    • We are working with top universities and premier partners in the healthcare space to bring our products to marketWe entered into a collaboration with Pfizer to test the ability of our technology to serve as a biomarker and cognitive enhancer in patients with prodromal (pre-symptomatic) Alzheimer’s disease (data presented at CTAD, see milestones above)
    • Shire Pharmaceuticals' (SHPG) Strategic Investment group, Merck Ventures V BV and Amgen Ventures are all investors in this program.
  • Expected Milestones and Timing
    • Our pivotal ADHD study, which assesses the efficacy and safety of Project: EVO in patients with pediatric ADHD, is expected to read out in the second half of 2017, with potential subsequent FDA filings as a digital treatment for ADHD. The trial was designed, with significant input from the FDA, to serve as a registration trial 
    • We are currently planning on or conducting multiple additional clinical trials across a variety of patient populations including autism spectrum disorder, depression, Alzheimer’s disease, multiple sclerosis, Parkinson’s disease and traumatic brain injury

The platform functions on the premise that advances in neuroscience research and consumer-facing technology are enabling a new way to sensitively measure neural function, and intervene in measured deficits, wherever the patient may be.  Our products address both quantitative measurement of and intensive intervention in cognitive functions in a variety of patient populations. The lead, patent-pending technology platform is based on cognitive science exclusively licensed from the lab of Dr. Adam Gazzaley at the University of California, San Francisco (UCSF), and proprietary adaptive algorithms developed by our team, all designed to be administered in the form of action video game interfaces. The platform powers both assessment (screens and monitors) and treatment products, which deploy real-time, adaptive cognitive challenges and interventions, respectively. 


Open-Label Proof of Concept Trial in Pediatric ADHD

Key Findings


Data: Efficacy Results from Open-Label Phase II Trial



Digital Biomarker Study in Healthy Subjects at Risk of Developing Alzheimer’s Disease

Key Findings


Data: Proprietary Akili AD Screen Reaction Time Metric



Pipeline