Clinical trial NCT04151290: Cognoa ASD Diagnosis Aid Validation Study
Official title: Cognoa ASD Diagnosis Aid Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Cognoa, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-05
Enrollment: 711
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will undergo both investigational and comparator diagnosis for ASD.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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

Eligibility criteria: General 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

General 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.

Primary outcomes:
measure: Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation
timeFrame: 6 Weeks
measure: No Result Percentage
timeFrame: 6 Weeks
Secondary outcomes:
measure: Device Sensitivity and Specificity
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Melmed Center
state: Arizona
city: Scottsdale
country: United States
facility: The Nicholls Group
state: Arizona
city: Laguna Niguel
country: United States
facility: Orange County Child Neurology
state: California
city: Laguna Niguel
country: United States
facility: Pediatric Neurology of Orange County
state: California
city: Laguna Niguel
country: United States
facility: Private Practice
state: California
city: Los Angeles
country: United States
facility: Private Practice
state: California
city: Palo Alto
country: United States
facility: Private Practice
state: California
city: Petal
country: United States
facility: MediSync Clinical Research Hattiesburg Clinic
state: Mississippi
city: Dayton
country: United States
facility: PriMed Clinical Research
state: Ohio
city: Austin
country: United States
facility: ARC Clinical Research at Wilson Parke
state: Texas
city: Austin
country: United States
facility: ARC Clinical Research William Cannon
state: Texas
city: Pflugerville
country: United States
facility: ARC Clinical Research Kelly Lane
state: Texas
city: Plano
country: United States
facility: Texas Child Neurology
state: Texas
city: Seattle
country: United States
facility: Private Practice
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Tacoma
country: United States
facility: Multicare Health System - Mary Bridge Pediatrics
state: Washington
Study officials:
affiliation: Cognoa, Inc.
name: Sharief Taraman, MD
role: STUDY_DIRECTOR
References: