Large study finds positive yet mixed results from Akili’s digital therapeutic for kids with ADHD

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Full pub­li­ca­tion of piv­otal tri­al data out­lines Akil­i’s case for FDA reg­u­la­tion (Mobi­Health­News):

“A full tran­script of STARS-ADHD — the piv­otal tri­al of Akili Interactive’s video game-like pedi­atric atten­tion deficit treat­ment — has been pub­lished in The Lancet Dig­i­tal Health jour­nal, pro­vid­ing onlook­ers a clear view of data fuel­ing the dig­i­tal ther­a­peu­tic company’s pend­ing FDA sub­mis­sion … Those in the inter­ven­tion group (n = 180) received a tablet with AKL-T01, which requires play­ers to focus on nav­i­gat­ing an alien avatar through a course while respond­ing to on-screen prompts. The con­trol group (n = 168) received an edu­ca­tion­al word game that was also designed by the company.

The pri­ma­ry out­come of inter­est was the mean change in TOVA API — an objec­tive, val­i­dat­ed mea­sure of atten­tion and inhibito­ry con­trol cleared by the FDA — after the inter­ven­tion peri­od. In this, the researchers saw a greater mean change in scores among the inter­ven­tion group (0.93) than in the con­trol group (0.03 ;adjust­ed p = .006) …

The per­for­mance of Akili’s treat­ment become a lit­tle more con­di­tion­al when review­ing the STARS-ADHD trial’s sec­ondary end­points. These includ­ed a vari­ety of scales and tools that Jina described as mea­sure­ments of behav­ioral or sub­jec­tive cog­ni­tive impact, rather than objec­tive symp­tom changes.

Patients who received AKL-T01 demon­strat­ed sig­nif­i­cant improve­ments across each of these mea­sures — but not enough of a boost to out­pace their peers receiv­ing the sham ther­a­py …  “Under­stand­ing the ben­e­fit of our tech­nol­o­gy when used along­side ADHD med­ica­tions has been a research pri­or­i­ty for us. Impor­tant­ly, par­ents see improve­ments in their chil­dren regard­less of whether they are using the treat­ment alone or along­side stim­u­lants,” Eddie Mar­tuc­ci, CEO of Akili, said last month in an announce­ment of the adjunct trial’s results.

Jina said that these stud­ies, tak­en in con­junc­tion with the company’s oth­er tri­als, should paint a clear enough pic­ture of AKL-T01 for reg­u­la­tors and clin­i­cians alike.”

The Study:

A nov­el dig­i­tal inter­ven­tion for active­ly reduc­ing sever­i­ty of pae­di­atric ADHD (STARS-ADHD): a ran­domised con­trolled tri­al (The Lancet Dig­i­tal Health). From the abstract:

• Back­ground: Atten­tion-deficit hyper­ac­tiv­i­ty dis­or­der (ADHD) is a com­mon pae­di­atric neu­rode­vel­op­men­tal dis­or­der with sub­stan­tial effect on fam­i­lies and soci­ety. Alter­na­tives to tra­di­tion­al care, includ­ing nov­el dig­i­tal ther­a­peu­tics, have shown promise to reme­di­ate cog­ni­tive deficits asso­ci­at­ed with this dis­or­der and may address bar­ri­ers to stan­dard ther­a­pies, such as phar­ma­co­log­i­cal inter­ven­tions and behav­iour­al ther­a­py. AKL-T01 is an inves­ti­ga­tion­al dig­i­tal ther­a­peu­tic designed to tar­get atten­tion and cog­ni­tive con­trol deliv­ered through a video game-like inter­face via at-home play for 25 min per day, 5 days per week for 4 weeks. This study aimed to assess whether AKL-T01 improved atten­tion­al per­for­mance in pae­di­atric patients with ADHD.
• Find­ings: Between July 15, 2016, and Nov 30, 2017, 857 patients were eval­u­at­ed and 348 were ran­dom­ly assigned to receive AKL-T01 or con­trol. Among patients who received AKL-T01 (n=180 [52%]; mean [SD] age, 9·7 [1·3] years) or con­trol (n=168 [48%]; mean [SD] age, 9·6 [1·3] years), the non-para­met­ric esti­mate of the pop­u­la­tion medi­an change from base­line TOVA API was 0·88 (95% CI 0·24–1·49; p=0·0060). The mean (SD) change from base­line on the TOVA API was 0·93 (3·15) in the AKL-T01 group and 0·03 (3·16) in the con­trol group. There were no seri­ous adverse events or dis­con­tin­u­a­tions. Treat­ment-relat­ed adverse events were mild and includ­ed frus­tra­tion (5 [3%] of 180) and headache (3 [2%] of 180). Patient com­pli­ance was a mean of 83 (83%) of 100 expect­ed ses­sions played (SD, 29·2 sessions).
• Inter­pre­ta­tion: Although future research is need­ed for this dig­i­tal inter­ven­tion, this study pro­vides evi­dence that AKL-T01 might be used to improve objec­tive­ly mea­sured inat­ten­tion in pae­di­atric patients with ADHD, while pre­sent­ing min­i­mal adverse events.

The Study in Context:

• Will dig­i­tal ther­a­peu­tics com­ple­ment or replace stim­u­lant med­ica­tions to address inat­ten­tion and “silent” cog­ni­tive issues?
• Study: Hav­ing ADHD costs $1.1 mil­lion in low­er life­time earn­ings, even when “treat­ed”
• Rein­vent­ing Brain Med­i­cine, Phar­ma adopts Dig­i­tal Therapeutics
• Five rea­sons the future of brain enhance­ment is dig­i­tal, per­va­sive and (hope­ful­ly) bright
• Pear Ther­a­peu­tics rais­es $50M to devel­op and mar­ket a port­fo­lio of dig­i­tal ther­a­peu­tics for men­tal health
• Pend­ing FDA review and approval, research find­ings pave way for Akili’s EVO to become first brain train­ing plat­form pre­scribed for ADHD
• The FDA cre­ates new Dig­i­tal Health unit to reimag­ine reg­u­la­to­ry paths in the age of scal­able, AI-enhanced innovation
• Can brain train­ing work? Yes, if it meets these 5 conditions