N/A
N=711
Cognoa ASD Diagnosis Aid Validation Study
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04151290 ↗Enrolled (actual)
711
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation — 80.8; 98.3 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognoa ASD diagnostic device (Diagnostic_test)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Cognoa, Inc.
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation |
80.8; 98.3 | — |
| PRIMARY No Result Percentage |
68.2 | — |
| SECONDARY Device Sensitivity and Specificity |
51.6; 18.5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04151290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.