Pending FDA review and approval, research findings pave way for Akili’s EVO to become first brain training platform prescribed for ADHD

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Akili Achieves Pri­ma­ry Effi­ca­cy End­point in ADHD Tri­al (MD magazine):

“Boston-based Akili Inter­ac­tive has announced top-line results from the STARS-ADHD piv­otal study of its inves­ti­ga­tion­al dig­i­tal ther­a­peu­tic med­i­cine AKL-T01, in treat­ment of pedi­atric atten­tion-deficit/hy­per­ac­tiv­i­ty dis­or­der (ADHD)…The dig­i­tal med­i­cine, AKL-T01, is a video game for patients to play on tablet devices. It uses the same sto­ry­telling and reward mech­a­nisms as stan­dard videogames; how­ev­er, it fea­tures mech­a­nisms to act on neur­al sys­tems and algo­rithms that dial the lev­el of stim­u­lus up or down, meet­ing the needs of the patient.

In the STARS-ADHD ran­dom­ized, con­trolled tri­al of 348 chil­dren and ado­les­cents diag­nosed with ADHD, AKL-T01 showed a sta­t­i­cal­ly sig­nif­i­cant improve­ment com­pared to an active con­trol group on the pre­de­fined pri­ma­ry end­point, a change in the Atten­tion Per­for­mance Index (API), a com­pos­ite score from the Test of Vari­ables of Atten­tion (TOVA)…

After the 4‑week peri­od, an assess­ment mea­sured changes from base­line on stan­dard mea­sures of atten­tion, mem­o­ry and impul­siv­i­ty. Chil­dren and ado­les­cents that received AKL-T01 showed a sta­tis­ti­cal­ly mean­ing­ful improve­ment in atten­tion­al func­tion­ing on the API…Engineered as a ther­a­peu­tic active treat­ment for cog­ni­tive defi­cien­cy, AKL-T01 is built on Akili’s patent­ed Project: EVO tech­nol­o­gy plat­form that allows selec­tive tar­get­ing and acti­va­tion of spe­cif­ic cog­ni­tive neur­al sys­tems in the brain that exhib­it defi­cien­cy from var­i­ous med­ical conditions…

Akili plans to file for reg­u­la­to­ry approval with the US Food and Drug Admin­is­tra­tion in the first half of 2018 for clear­ance as a nov­el treat­ment for chil­dren and ado­les­cents with ADHD, paving the way for the first ‘dig­i­tal’ pre­scrip­tion prod­uct to direct­ly treat a disorder.

The com­pa­ny is also study­ing whether a sim­i­lar ver­sion of its video game could poten­tial­ly treat adults with depres­sion, and the Akili recent­ly start­ed a mid-stage clin­i­cal tri­al with ear­ly results expect­ed late next year.”

The Study (ongoing)

Soft­ware Treat­ment for Active­ly Reduc­ing Sever­i­ty of ADHD (STARS-ADHD) (ClinicalTrials.gov)

  • Pur­pose: The pur­pose of this study is to eval­u­ate the effects of videogame-like dig­i­tal ther­a­pies on atten­tion­al func­tion­ing and symp­toms in chil­dren diag­nosed with ADHD.
  • Offi­cial title: A Ran­dom­ized, Con­trolled, Par­al­lel-group, Inter­ven­tion Study to Assess At-home, Game-based Dig­i­tal Ther­a­py for Treat­ing Pedi­atric Par­tic­i­pants Ages 8 to 12 Years Old With Atten­tion Deficit Hyper­ac­tiv­i­ty Dis­or­der (ADHD)
  • Detailed descrip­tion: The study will be a ran­dom­ized, par­al­lel group, con­trolled tri­al of two videogame-like (iPad-based) dig­i­tal ther­a­pies. The study will con­sist of 3 pri­ma­ry phas­es: Screen­ing, Washout/Baseline, and Treat­ment. Dur­ing the Screen­ing Phase (Day ‑28 to Day ‑7), par­tic­i­pants will under­go screen­ing to eval­u­ate eli­gi­bil­i­ty for the study. Screen­ing may take place up to 28 days before the Base­line Vis­it (Day 0). For those chil­dren cur­rent­ly on med­ica­tion for ADHD the Washout peri­od will begin 7 days pri­or to Base­line where treat­ment will be dis­con­tin­ued. On Day 0, the Base­line vis­it will occur where­in addi­tion­al eli­gi­bil­i­ty cri­te­ria will be estab­lished. The Treat­ment Phase (Day 1 to Day 27) will involve using the dig­i­tal ther­a­py at home for each par­tic­i­pant fol­lowed by an In-Clin­ic assess­ment on Day 28 to assess key out­comes. Com­pli­ance with treatment/use require­ments will be mon­i­tored remote­ly dur­ing this phase.
  • Just announced top-line results: HERE

The Study in Context