NCT04151290 is a NA clinical trial of Cognoa ASD diagnostic device in Autism Spectrum Disorder, sponsored by Cognoa, Inc..

Who is sponsoring NCT04151290?

NCT04151290 is sponsored by Cognoa, Inc..

What drugs are being tested in NCT04151290?

Interventions in NCT04151290: Cognoa ASD diagnostic device.

What condition does NCT04151290 study?

NCT04151290 studies Autism Spectrum Disorder.

Is NCT04151290 still recruiting?

NCT04151290 is currently completed. Last updated 28 December 2021.

Are results published for NCT04151290?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-12-28 · How we verify

NCT04151290

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cognoa ASD Diagnosis Aid Validation Study

Completed NA Results posted Last updated 28 December 2021

What this trial tests

NA trial testing Cognoa ASD diagnostic device in Autism Spectrum Disorder in 711 participants. Completed in 31 August 2020.

Timeline

7 August 2019

Primary endpoint
5 June 2020

31 August 2020

Quick facts

Lead sponsor	Cognoa, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	711
Start date	7 August 2019
Primary completion	5 June 2020
Estimated completion	31 August 2020
Sites	16 locations across United States

Drugs / interventions tested

Cognoa ASD diagnostic device

Conditions studied

Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Cognoa, Inc.

Who can join

Adults 18 Months to 72 Months, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation Primary · 6 Weeks

Achievement of a composite of positive predictive value (PPV) greater than 65% and negative predictive value (NPV) greater than 85% for the device in relation to the clinical reference standard in the overall study population:

PPV

Group	Value	95% CI
Cognoa Assessment	80.8	70.3 – 88.8

NPV

Group	Value	95% CI
Cognoa Assessment	98.3	90.6 – 100

No Result Percentage Primary · 6 Weeks

Measurement of the percentage of children for whom the device has provided no result.

Group	Value	95% CI
Cognoa Assessment	68.2	63.6 – 72.6

Device Sensitivity and Specificity Secondary · 6 Weeks

Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population.

Sensitivity

Group	Value	95% CI
Cognoa Assessment	51.6	42.4 – 60.8

Specificity

Group	Value	95% CI
Cognoa Assessment	18.5	14.3 – 23.3

Sponsor's own description

The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Evaluation of an artificial intelligence-based medical device for diagnosis of autism spectrum disorder.
Megerian JT, Dey S, Melmed RD, Coury DL, et al · · 2022 · cited 54× · PMID 35513550 · DOI 10.1038/s41746-022-00598-6
An analysis of the real world performance of an artificial intelligence based autism diagnostic.
Salomon C, Heinz K, Aronson-Ramos J, Wall DP. · · 2025 · cited 2× · PMID 40796609 · DOI 10.1038/s41598-025-15575-8

Verify or expand the search:

Other recruiting trials for Autism Spectrum Disorder

Currently open trials in the same condition.

NCT07324057 — The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavi · NA · recruiting
NCT07493096 — Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disor · recruiting
NCT07505290 — Efficacy of the Korean PEERS® for Preschoolers (PEERS®-PS-K) Social Skills Intervention: A Randomized Controlled Trial f · NA · active not recruiting
NCT07524192 — A Self-Instructional Online Program for Early Childhood and Elementary Teachers Supporting Autistic Children and Childre · NA · recruiting
NCT07432776 — Effect of an 8-Week Pickleball Program for Adults With Autism: A Feasibility Trial With a Delayed-Control Design · EARLY_PHASE1 · recruiting

Other Cognoa, Inc. trials

Trials by the same sponsor.

NCT05223374 — Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting · completed
NCT04326231 — Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study · NA · terminated
NCT03871179 — Cognoa ASD Diagnostic Device - Data Collection Study · NA · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04151290 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cognoa, Inc.
Last refreshed: 28 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04151290.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing