Study to Assess the Janssen Autism Knowledge Engine in Participants With Autism Spectrum Disorder and in a Normally Developing Cohort

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Autism Spectrum Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT02668991

CR106701

MENTIS-ASD002 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the utility of and to clinically validate the Autism Behavior Inventory (ABI) in measuring clinical symptoms of Autism Spectrum Disorder (ASD) compared with other gold standard measures.

Full description

This is an observational study (in which participants identified as belonging to study groups are assessed for biomedical or health outcomes) to evaluate the utility of Janssen Autism Knowledge Engine (JAKE) in measuring clinical symptoms of ASD in children and adults with ASD. The study will consist of 3 cohorts of participants. For Cohort 1 and 2, there will be 14-day Screening phase and 8-week (Cohort 1) or 10 week (Cohort 2) data collection phase extending from Day 0 (Baseline) to Day 56 or Day 70, respectively. For Cohort 3, the study will consist of a screening visit and a single testing visit, which may be combined. Primarily, the usability of JAKE as a system to monitor clinical outcomes in ASD will be assessed. Participants' safety will be monitored throughout the study.

Enrollment: 186 patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Cohort 1 and 2:

• Participants must be males or females aged 6 years and older with at least one female for every five male participants
• Diagnosis of ASD made or confirmed using the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2)
• Participants can receive behavioral and/or pharmacologic treatments for ASD and comorbid disorders during the course of the study, or not (Cohort 1)
• In cohort 2, as part of their standard care participants must be about to begin a behavioral intervention within 2 weeks after the Baseline visit
• Parents or legally authorized representatives must speak and understand English

Cohort 3:

• Participants must be males or females aged 6 years and older with at least one female for every five male participants.
• Parents or legally authorized representatives must speak and understand English
• In the opinion of the investigator, subject and parents must be capable of completing all procedures and tasks of the study
• Each participant or their legally authorized representative must sign an informed consent form (ICF)
• A score in the normal range on the Social Communication Questionnaire (SCQ) and must not have any Diagnostic and Statistical Manual of Mental Disorders

Exclusion criteria

Cohort 1 and 2:

• Measured composite score on the Kaufmann Brief Intelligence Test-2 (KBIT-2) of less than 60
• History of, or current significant medical illness that the Investigator considers should exclude the participant
• Psychological and/or emotional problems which would render the informed consent invalid or limit the ability of the subject to comply with the study requirements
• Any condition that in the opinion of the investigator would compromise the study, or the wellbeing of the subject; for example, visual problems that would impede eye-tracking or viewing the stimuli or hearing problems that would impede hearing auditory stimuli
• Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator

Cohort 3:

• History of or current significant medical illness that the Investigator considers should exclude the participant
• Psychological and/or emotional problems which would render the informed consent invalid or limit the ability of the participant to comply with the study requirements
• Any condition that in the opinion of the investigator would compromise the study, or the wellbeing of the subject; for example, visual problems that would impede eye-tracking or viewing the stimuli or hearing problems that would impede hearing auditory stimuli
• Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
• Participant should not take any sedating medications on the day of the test battery and should not consume caffeine within 2 hours prior to the battery

Trial design

186 participants in 3 patient groups

Cohort 1

Description:

It will consist of planned 100 children and adults with Autism Spectrum Disorder (ASD) aged 6 years and older with no requirements regarding concurrent therapies or treatments.

Cohort 2

Description:

It will consist of planned 50 children and adults aged 6 and older who, as part of their standard care, happen to be beginning a behavioral intervention within 2 weeks after the baseline visit of the study. This intervention can be an applied behavior analysis (ABA) program or similar or a social skills program or a school-based autism program and must be intended to last at least throughout the duration of the study.

Cohort 3

Description:

It will consist of planned 30 normally developing children and adults. These participants will only have a single visit wherein they will undergo a single session with the task battery and biosensors. There should be 5 participants aged 6-9 years, 5 aged 10-12 years, 5 aged 13-17 years, and 5 aged 18 years and older. This cohort should approximate the male:female ratio in Cohorts 1 \& 2, with approximately 1 female for every 5 males.