Trial Outcomes & Findings for Cognoa ASD Diagnosis Aid Validation Study (NCT NCT04151290)
NCT ID: NCT04151290
Last Updated: 2021-12-28
Results Overview
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:
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
711 participants
Primary outcome timeframe
6 Weeks
Results posted on
2021-12-28
Participant Flow
Participant milestones
| Measure |
Cognoa Assessment
Cognoa diagnostic ASD device.
Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
|
|---|---|
|
Overall Study
STARTED
|
711
|
|
Overall Study
COMPLETED
|
425
|
|
Overall Study
NOT COMPLETED
|
286
|
Reasons for withdrawal
| Measure |
Cognoa Assessment
Cognoa diagnostic ASD device.
Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
|
|---|---|
|
Overall Study
The COVID-19 Pandemic made it hard for subjects to complete the study.
|
286
|
Baseline Characteristics
Cognoa ASD Diagnosis Aid Validation Study
Baseline characteristics by cohort
| Measure |
Cognoa Assessment
n=425 Participants
Cognoa diagnostic ASD device.
Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
|
|---|---|
|
Age, Categorical
<=18 years
|
425 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
3.3 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
271 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race\Ethnicity · American Indian only
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race\Ethnicity · Asian only
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race\Ethnicity · Black only
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race\Ethnicity · Hawaiian or Pacific Islander only
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race\Ethnicity · Hispanic or Latino or Latino only
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race\Ethnicity · Multiple races and/or ethnicities indicated
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race\Ethnicity · Non-Hispanic White only
|
229 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race\Ethnicity · Other race indicated only
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race\Ethnicity · Unknown
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 WeeksPopulation: Participants
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:
Outcome measures
| Measure |
Cognoa Assessment
n=425 Participants
Cognoa diagnostic ASD device.
Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
|
|---|---|
|
Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation
PPV
|
80.8 percent
Interval 70.3 to 88.8
|
|
Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation
NPV
|
98.3 percent
Interval 90.6 to 100.0
|
PRIMARY outcome
Timeframe: 6 WeeksPopulation: Participants
Measurement of the percentage of children for whom the device has provided no result.
Outcome measures
| Measure |
Cognoa Assessment
n=425 Participants
Cognoa diagnostic ASD device.
Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
|
|---|---|
|
No Result Percentage
|
68.2 percent
Interval 63.6 to 72.6
|
SECONDARY outcome
Timeframe: 6 WeeksPopulation: Participants
Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population.
Outcome measures
| Measure |
Cognoa Assessment
n=425 Participants
Cognoa diagnostic ASD device.
Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
|
|---|---|
|
Device Sensitivity and Specificity
Sensitivity
|
51.6 percent
Interval 42.4 to 60.8
|
|
Device Sensitivity and Specificity
Specificity
|
18.5 percent
Interval 14.3 to 23.3
|
Adverse Events
Cognoa Assessment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pub./disc. of the Study(30)days prior to submission for pub./disc. Sponsor to review/comment on the proposed pub./disc. identify any Confidential Information of Sponsor to be deleted from the proposed pub./disc.; protect proprietary rights to Inventions. Sponsor shall provide comments or identify any Confidential Information to be deleted from the proposed pub./disc.(30)day period.Upon Sponsor's reasonable request prior to expiration of the initial thirty (30) day review,Investigator shall delay
- Publication restrictions are in place
Restriction type: OTHER