|Project:EVO--Courtesy of Akili|
Akili Interactive Labs has partnered with the nonprofit Autism Speaks to conduct a clinical trial of its cognitive assessment and personalized treatment video game.
This is the latest in a clutch of clinical trials for the technology in various indications that are related to higher order executive brain functions. These typically involve difficulties with problem solving, memory, prioritizing multiple activities and self-regulation.
The autism trial is slated to be a randomized, double-blind and sham-controlled study of more than 100 people. It's expected to validate the use of the system to aid and assess people on the autism spectrum. The collaboration is specifically with DELSIA (Delivering Scientific Innovation for Autism), the not-for-profit venture philanthropy affiliate of Autism Speaks.
The startup's cognitive platform is based on the Project:EVO technology that the company in-licensed from the University of California, San Francisco, laboratory of Dr. Adam Gazzaley, whose related research was featured on the cover of the journal Nature.
That study found that a 10-hour protocol with 30-minute increments of play with a game called NeuroRacer over a one-month period was correlated with improvement in cognitive function for participants who were 65 or over. Even 6 months later, the improvements remained.
Those are the only disclosed clinical data thus far. During the second quarter, Akili expects to wrap up a trial in pediatric ADHD that it's conducting in conjunction with Shire ($SHPG). That trial is at three sites, with the lead at Duke University. Shire has also made an undisclosed strategic investment in Akili.
In addition, the startup expects to have results before year-end from a large trial in Alzheimer's conducted with Pfizer ($PFE). That trial is part of a larger partnership with Pfizer that encompasses several studies. In the Alzheimer's trial, the hope is that performance on the Akili video game technology eventually will serve to indicate a biomarker or cognitive endpoint for individuals at risk for Alzheimer's disease.
Another trial for the video game technology as a depression intervention is being sponsored by the National Institute of Mental Health and conducted entirely on smartphones and mobile tablets.
Akili's strategy is to assemble enough clinical data to demonstrate the technology's usefulness to physicians. It plans to follow the full medical device regulatory pathway, which is an area that is largely untried.
|Akili COO Eddie Martucci|
"We will make our products mainstream medical product, not small niche ones," Akili co-founder and COO W. Eddie Martucci told FierceMedicalDevices in an interview. "We are following a strategy to bring this forward as a medical device that would go through CDRH and fall under the regulations for mobile medical devices."
"It's an interesting path for us because we are kind of blazing new ground," Martucci said. "It's important to bring a product forward as something the medical community will respect and demand."
Akili was co-founded by PureTech and has three versions of its clinical game technology, which will be a mobile-first technology for smartphones and mobile tablets.