Cognoa ASD Diagnosis Aid Validation Study
1 other identifier
interventional
711
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2019
CompletedFirst Submitted
Initial submission to the registry
October 9, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedResults Posted
Study results publicly available
December 28, 2021
CompletedDecember 28, 2021
November 1, 2021
10 months
October 9, 2019
June 18, 2021
November 29, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation
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:
6 Weeks
No Result Percentage
Measurement of the percentage of children for whom the device has provided no result.
6 Weeks
Secondary Outcomes (1)
Device Sensitivity and Specificity
6 Weeks
Study Arms (1)
Cognoa Assessment
EXPERIMENTALCognoa diagnostic ASD device.
Interventions
Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cognoa, Inc.lead
Study Sites (16)
Melmed Center
Scottsdale, Arizona, 85254, United States
The Nicholls Group
Scottsdale, Arizona, 85258, United States
Orange County Child Neurology
Laguna Niguel, California, 92677, United States
Pediatric Neurology of Orange County
Laguna Niguel, California, 92677, United States
Private Practice
Laguna Niguel, California, 92677, United States
Private Practice
Los Angeles, California, 90034, United States
Private Practice
Palo Alto, California, 94303, United States
MediSync Clinical Research Hattiesburg Clinic
Petal, Mississippi, 39465, United States
PriMed Clinical Research
Dayton, Ohio, 45419, United States
ARC Clinical Research at Wilson Parke
Austin, Texas, 78726, United States
ARC Clinical Research William Cannon
Austin, Texas, 78745, United States
ARC Clinical Research Kelly Lane
Pflugerville, Texas, 78660, United States
Texas Child Neurology
Plano, Texas, 75024, United States
Private Practice
Seattle, Washington, 98103, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Multicare Health System - Mary Bridge Pediatrics
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Research
- Organization
- Cognoa
Study Officials
- STUDY DIRECTOR
Sharief Taraman, MD
Cognoa, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- All participants and healthcare providers will be blinded to the diagnosis results.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2019
First Posted
November 5, 2019
Study Start
August 7, 2019
Primary Completion
June 5, 2020
Study Completion
August 31, 2020
Last Updated
December 28, 2021
Results First Posted
December 28, 2021
Record last verified: 2021-11