Abstract
Objective: The Janssen Autism Knowledge Engine (JAKE®) is a clinical research outcomes assessment system developed to more sensitively measure treatment outcomes and identify subpopulations in autism spectrum disorder (ASD). Here we describe JAKE and present results from its digital phenotyping (My JAKE) and biosensor (JAKE Sense) components.Methods: An observational, non-interventional, prospective study of JAKE in children and adults with ASD was conducted at nine sites in the United States. Feedback on JAKE usability was obtained from caregivers. JAKE Sense included electroencephalography, eye tracking, electrocardiography, electrodermal activity, facial affect analysis, and actigraphy. Caregivers of individuals with ASD reported behaviors using My JAKE. Results from My JAKE and JAKE Sense were compared to traditional ASD symptom measures.Results: Individuals with ASD (N = 144) and a cohort of typically developing (TD) individuals (N = 41) participated in JAKE Sense. Most caregivers reported that overall use and utility of My JAKE was “easy” (69%, 74/108) or “very easy” (74%, 80/108). My JAKE could detect differences in ASD symptoms as measured by traditional methods. The majority of biosensors included in JAKE Sense captured sizable amounts of quality data (i.e., 93–100% of eye tracker, facial affect analysis, and electrocardiogram data was of good quality), demonstrated differences between TD and ASD individuals, and correlated with ASD symptom scales. No significant safety events were reported.Conclusions: My JAKE was viewed as easy or very easy to use by caregivers participating in research outside of a clinical study. My JAKE sensitively measured a broad range of ASD symptoms. JAKE Sense biosensors were well-tolerated. JAKE functioned well when used at clinical sites previously inexperienced with some of the technologies. Lessons from the study will optimize JAKE for use in clinical trials to assess ASD interventions. Additionally, because biosensors were able to detect features differentiating TD and ASD individuals, and also were correlated with standardized symptom scales, these measures could be explored as potential biomarkers for ASD and as endpoints in future clinical studies.Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02668991 identifier: NCT02668991
Highlights
Accepted, standardized tools for diagnosing autism spectrum disorder (ASD) include the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) and the Autism Diagnostic Interview-Revised (Falkmer et al, 2013)
Global efforts to identify potential biomarkers for use in ASD research have been noted in the European Union (EU) and US
The mean (SD) age of ASD participants was 14.6 (7.83) years compared with a mean (SD) age of 16.3 (13.18) years for typically developing (TD) participants
Summary
Accepted, standardized tools for diagnosing autism spectrum disorder (ASD) include the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) and the Autism Diagnostic Interview-Revised (Falkmer et al, 2013). In the US, the Autism Biomarkers Consortium Clinical Trial (ABC-CT) is engaged in a similar effort to examine change over time in a younger cohort of children and adolescents with ASD (McPartland, 2018). These large-scale consortia utilize a select group of expert academic sites and employ high-density tools (e.g., 128 lead electroencephalogram [EEG] and magnetic resonance imaging) to help identify biomarkers to stratify subgroups of individuals with ASD that might be more responsive to a particular therapy, and to measure change in symptoms and behavior over time
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