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Cognoa ASD Diagnosis Aid Validation Study | Clinical Trials | Clareo Health

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COMPLETEDNANCT04151290

Cognoa ASD Diagnosis Aid Validation Study

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.

Lead sponsor: Cognoa, Inc.•16 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Cognoa, Inc.

To assess the ability of the diagnostic device to aid in the diagnosis of ASD by comparing its diagnostic output with the clinical reference standard, consisting of a diagnosis made by a specialist clinician, based on DSM-5 criteria and validated by one or more reviewing specialist clinicians

Age

1 - 6 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
•Caregiver or HCP concern for developmental delay.
•Female or Male, \>18 to \<72 months of age

Exclusion Criteria

•Subjects with a prior diagnosis of ASD rendered by a healthcare professional.
•Subjects whose age on the date of enrollment is outside the target age range.
•Subjects or caregivers who have been previously enrolled in any Cognoa clinical study or survey.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 28, 2021Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment711

Start dateAug 2019

Last updatedDec 28, 2021

Condition

Autism Spectrum Disorder

Locations shown

Melmed Center

Scottsdale, Arizona

The Nicholls Group

Scottsdale, Arizona

Orange County Child Neurology

Laguna Niguel, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2021Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions