Large multi-center study to test videogame-like digital therapy as (potentially) FDA-cleared ADHD treatment

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evo_akiliAkili Labs recruits for ADHD tri­al with ambi­tions of FDA clear­ance for dig­i­tal med­i­cine (Med­C­i­ty News)

“Akili Labs has kicked off open enroll­ment for a clin­i­cal tri­al of its Project EVO video game plat­form in a quest to secure for 510(k) clear­ance from the U.S. Food and Drug Admin­is­tra­tion for its lead indi­ca­tion — atten­tion deficit hyper­ac­tiv­i­ty disorder.

The tri­al is recruit­ing at least 300 par­tic­i­pants aged 8–12 years old who have been diag­nosed with ADHD. It will eval­u­ate the safe­ty and effi­ca­cy of the Project EVO plat­form, accord­ing to a com­pa­ny state­ment. The ulti­mate goal is to pro­vide a drug alter­na­tive for chil­dren with ADHD and Akili Labs CEO Eddie Mar­tuc­ci views dig­i­tal ther­a­peu­tics as the way to do that…If the tri­al meets its end­points, the com­pa­ny plans to sub­mit Project EVO for FDA approval.

In a phone inter­view in Feb­ru­ary Mar­tuc­ci said, “We want this to stand along­side Adder­all and oth­er drugs as a doc­tor-pre­scribed treatment.”

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

  • Brief sum­ma­ry: 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.
  • 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.

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