Autism Spectrum Disorder
Conditions
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
Interventions
DIAGNOSTIC_TESTCognoa ASD diagnostic device
Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
Sponsors
Cognoa, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
All participants and healthcare providers will be blinded to the diagnosis results.
Intervention model description
All subjects will undergo both investigational and comparator diagnosis for ASD.
Eligibility
Sex/Gender
ALL
Age
18 Months to 72 Months
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation | 6 Weeks | 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: |
| No Result Percentage | 6 Weeks | Measurement of the percentage of children for whom the device has provided no result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Sensitivity and Specificity | 6 Weeks | Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognoa Assessment Cognoa diagnostic ASD device.
Cognoa ASD diagnostic device: Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD) | 425 |
| Total | 425 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | The COVID-19 Pandemic made it hard for subjects to complete the study. | 286 |
Baseline characteristics
| Characteristic | Cognoa Assessment |
|---|---|
| Age, Categorical <=18 years | 425 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 3.3 years STANDARD_DEVIATION 1.2 |
| Race/Ethnicity, Customized Race\Ethnicity American Indian only | 0 Participants |
| Race/Ethnicity, Customized Race\Ethnicity Asian only | 18 Participants |
| Race/Ethnicity, Customized Race\Ethnicity Black only | 56 Participants |
| Race/Ethnicity, Customized Race\Ethnicity Hawaiian or Pacific Islander only | 1 Participants |
| Race/Ethnicity, Customized Race\Ethnicity Hispanic or Latino or Latino only | 49 Participants |
| Race/Ethnicity, Customized Race\Ethnicity Multiple races and/or ethnicities indicated | 57 Participants |
| Race/Ethnicity, Customized Race\Ethnicity Non-Hispanic White only | 229 Participants |
| Race/Ethnicity, Customized Race\Ethnicity Other race indicated only | 5 Participants |
| Race/Ethnicity, Customized Race\Ethnicity Unknown | 10 Participants |
| Sex: Female, Male Female | 154 Participants |
| Sex: Female, Male Male | 271 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 425 |
| other Total, other adverse events | 0 / 425 |
| serious Total, serious adverse events | 0 / 425 |
Outcome results
Primary
No Result Percentage
Measurement of the percentage of children for whom the device has provided no result.
Time frame: 6 Weeks
Population: Participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cognoa Assessment | No Result Percentage | 68.2 percent |
Primary
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:
Time frame: 6 Weeks
Population: Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cognoa Assessment | Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation | PPV | 80.8 percent |
| Cognoa Assessment | Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation | NPV | 98.3 percent |
Secondary
Device Sensitivity and Specificity
Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population.
Time frame: 6 Weeks
Population: Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cognoa Assessment | Device Sensitivity and Specificity | Sensitivity | 51.6 percent |
| Cognoa Assessment | Device Sensitivity and Specificity | Specificity | 18.5 percent |