Will digital therapeutics complement or replace stimulant medications to address inattention and “silent” cognitive issues?

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Akili Inter­ac­tive: Dig­i­tal pedi­atric ADHD ther­a­peu­tic per­forms well with or with­out accom­pa­ny­ing stim­u­lant ther­a­py (Mobi­Health News):

“Dig­i­tal ther­a­peu­tic com­pa­ny Akili Inter­ac­tive has announced the first results of an open-label, mul­ti­site pedi­atric ADHD tri­al pro­vid­ing some patients with the company’s video game-like treat­ment along­side a stim­u­lant medication.

Accord­ing to the com­pa­ny, both those who received the AKL-T01 ther­a­py with (n = 130) or with­out (n = 76) accom­pa­ny­ing stim­u­lant med­ica­tion saw sig­nif­i­cant improve­ments one month after base­line (p < .001) as mea­sured by the trial’s pri­ma­ry out­come, rat­ings on the ADHD Impair­ment Rat­ing Scale (IRS) report­ed by par­ents … While a full report­ing of the study data is still being pre­pared for upcom­ing con­fer­ences or jour­nal pub­li­ca­tion, Akili views these find­ings as evi­dence that AKL-T01 pro­vides a ben­e­fit “inde­pen­dent of whether the chil­dren were on or off ADHD medication.”

The Study:

Akili Study of AKL-T01 With and With­out Stim­u­lant Med­ica­tion in Chil­dren With ADHD Achieves Pri­ma­ry Effi­ca­cy End­point (press release):

“Fol­low­ing our suc­cess­ful piv­otal STARS-ADHD study of AKL-T01 as a poten­tial treat­ment for inat­ten­tion in chil­dren with ADHD not tak­ing stim­u­lant med­ica­tions, 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,” said Eddie Mar­tuc­ci, CEO of Akili. “As we con­tin­ue to work toward FDA clear­ance for this nov­el ther­a­peu­tic for inat­ten­tion in chil­dren with ADHD, these data and the ben­e­fits expressed by par­ents and physi­cians in this study lend fur­ther cre­dence to the impor­tant role AKL-T01 can play in the treat­ment of ADHD.”

More than 5.5 mil­lion chil­dren diag­nosed with ADHD strug­gle with atten­tion issues. Inat­ten­tion and oth­er “silent” cog­ni­tive issues often go unrec­og­nized in the face of oth­er more overt dis­ease symp­toms, yet they sig­nif­i­cant­ly impact dai­ly func­tion­ing. “Chil­dren with ADHD are joined by mil­lions of oth­ers, both with and with­out med­ical diag­noses, who expe­ri­ence chal­lenges in their dai­ly lives due to inat­ten­tion or oth­er cog­ni­tive issues. We’re com­mit­ted to dri­ving greater aware­ness and recog­ni­tion of the impact of these cog­ni­tive issues and advanc­ing nov­el approach­es to help all those affect­ed,” said Anil Jina, M.D., Akili’s Chief Med­ical Officer.

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