ADHD + Autism Spectrum Disorder (ASD)

A randomized, double-blind, controlled study of AKL-T02 (which retains the same SSME therapeutic engine as AKL-T01) in 19 children ages 9-13 years old with ASD and comorbid ADHD, 11 randomized to AKL-T02 and 8 to digital control. AKL-T02 group improved in TOVA API (mean change=1.86, p=0.12, d=0.72) while the Control group worsened (mean change= -0.82, p=0.55, d=0.35). AKL-T02 group improved in ADHD symptoms (ADHD-RS-Total, mean change= -6.72, p=0.003, d=2.03). Both groups had high compliance with their intervention. There was one non-serious adverse event (decreased frustration tolerance) in the AKL-T02 group.


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Clinical Endpoint Acronyms

AA-QoL:
Adult ADHD Quality of Life Score
ADHD-RS:
ADHD Rating Scale (total score)
ADHD-RS-Hyperactive:
ADHD-RS hyperactivity-impulsivity subscale
ADHD-RS-Inattentive:
ADHD-RS inattention subscale
BRIEF:
Behavior Rating Inventory of Executive Function
CAARS-S:
Conners' Adult ADHD Rating Scales–Self Report: Short Version
CGI-I:
Clinical Global Impression - Improvement
EEG:
Electroencephalogram
IRS:
Impairment Rating Scale to measure ADHD-related impairment
MFT:
Mid-Frontal Theta
TOVA®:
Test of Variables of Attention
TOVA API:
TOVA Attention Performance Index (also known as TOVA ACS)
TOVA ACS:
TOVA Attention Comparison Score (formerly known as TOVA API)
TOVA RT Mean H1:
TOVA Reaction Time Mean (first half of the test)
TOVA RT Var:
TOVA Reaction Time Variability (total test)