AKL-T01 - a digital treatment for inattention in ADHD improved ADHD-related impairment in 2 out of 3
children with ADHD, independent of their ADHD
medication status aﬅer 2 treatment months.

AKL-T01, a Digital Treatment for Pediatric
ADHD as an Adjunct to Stimulant Medication:
Response Rates With Repeat Administration
Ann Catherine Childress, MD¹; Jacqueline Lutz, PhD²; Scott H. Kollins, PhD³
¹Center for Psychiatry and Behavioral Medicine Inc., Las Vegas, NV. 2Akili interactive
3Psychiatry & Behavioral Sciences, Duke University Medical Center, Durham, NC.

BackgroundSTARS-Adjunct trial goals:

Results
Responder rates in ADHD-related impairment and symptoms
AKL-T01 Response Rate: STARS-Adjunct1. What is the eﬀect of combining AKL-T01 withstimulant medication?
2. What is the eﬀect of a second treatment monthin children on and oﬀ stimulant medication?
AKL-T01 is a digital treatment designed to improve attentionfunction in ADHD delivered through a video-game interface.
Previous STARS-ADHD RCT:
Significant responder rate of 48% on ADHD-related impairment(Impairment Rating Scale, IRS) compared to digital control(37%) in children with ADHD but without ADHD medication who
used AKL-T01 for 1 month.

Outcome
MeasureResponse Rate
Definition

No Stimulants

On Stimulants

Both Cohorts

STARSADHD RCT

Day 28

Day 84

Day 28

Day 84

Day 28

Day 84

Day 28% children with ≥ 1improvement on IRS
Overall Severity

40.5%

69.7%

55.5%

68.1%

50%

68.3%

48%

% children with≥30% improvement
on ADHD-RS Total

27%

49.2%

27.3%

43%

27.2%

45.3%

24%

ADHD-RS
Inattention
subscale% children with≥30% improvement
on ADHD-RS
Inattention subscale

27%

38.8%

28.9%

41.2%

28.2%

40.3%

26%

Clinical Global
ImpressionImprovement scale(CGI-I)% children with scoreof ≤2 (very much ormuch improved)

13.5%

Impairment RatingScale(IRS)ADHD totalsymptoms(ADHD-RS Total)

25.4%

15.6%

28.8%

14.9%

STARS-Adjunct open label trial responder rates
in children on or oﬀ ADHD medication
replicate response rates in STARS-ADHD RCT.

27.6%

17%

STARS-Adjunct was an open-label, 3-month trial, across 15 sites (NCT03649074).
Participants: 206 children, m/f, 8-14yo, with ADHD, `On stimulants` or not on any ADHD medication (`No Stimulants`) and ADHD-related impairment (IRS ≥ 3).
STUDY DESIGNFIGURE 02

A second AKL-T01 treatment monthlead to increased responder rates in
ADHD symptoms and impairment.

Nearly 70% of
parents reported
improvement in
ADHD-related
impairment aﬅer
using AKL-T01 fora second
treatment month,in children on andoﬀ stimulant
medication.

Methods

FIGURE 01

Conclusions

A second monthof treatment (Day84) increased
responder rates in
ADHD symptoms
and impairment.

SCREENSHOT FROM AKL-T01

Comparable responder
rates, across:
ADHD medication status:
children on versus oﬀ stimulants.
Trial design: open label versus
RCT.

REFERENCES
Kollins et al., A Novel Digital Intervention for Actively
Reducing Severity of Paediatric ADHD (STARS-ADHD): A
Randomised Controlled Trial, The Lancet Digital Health 2,no. 4 (April 1, 2020): e168–78.
1

DISCLOSURES
ACC is on the avisory board and received research support
from Akili interactive. SHK is consultant, received researchsupport and may own stock or equity at Akili interactive.
JL is employee at Akili interactive and may own stock
options or equity at Akili interactive.