Autism Spectrum DisorderNCT04151290
Cognoa ASD Diagnosis Aid Validation Study
A study testing Cognoa ASD diagnostic device in people with Autism Spectrum Disorder, run by Cognoa, Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Cognoa ASD diagnostic device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 711 participants
- Where
- 16 sitesUnited States
- Study dates
- 7 Aug 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 months
- All sexes
- No healthy volunteers
- Child
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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
ARC Clinical Research at Wilson Parke
Austin, Texas, 78726
ARC Clinical Research William Cannon
Austin, Texas, 78745
PriMed Clinical Research
Dayton, Ohio, 45419
Orange County Child Neurology
Laguna Niguel, California, 92677
Pediatric Neurology of Orange County
Laguna Niguel, California, 92677
Private Practice
Laguna Niguel, California, 92677
Private Practice
Los Angeles, California, 90034
Private Practice
Palo Alto, California, 94303
MediSync Clinical Research Hattiesburg Clinic
Petal, Mississippi, 39465
ARC Clinical Research Kelly Lane
Pflugerville, Texas, 78660
Texas Child Neurology
Plano, Texas, 75024
Melmed Center
Scottsdale, Arizona, 85254
The Nicholls Group
Scottsdale, Arizona, 85258
Private Practice
Seattle, Washington, 98103
Seattle Children's Hospital
Seattle, Washington, 98105
Multicare Health System - Mary Bridge Pediatrics
Tacoma, Washington, 98405
About this study
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.
Read the 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
- Conditions
- Autism Spectrum Disorder
- Being tested
- Cognoa ASD diagnostic device
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognoa ASD diagnostic deviceDiagnostic test
Cognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD)
| Study group | Role | What they receive |
|---|---|---|
| Cognoa Assessment | Experimental | Cognoa diagnostic ASD device. Receives: Diagnostic Test: Cognoa ASD diagnostic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: 6 Weeks
No Result Percentage
Measurement of the percentage of children for whom the device has provided no result.
Measured: 6 Weeks
Secondary outcomes (1)
Device Sensitivity and Specificity
Sensitivity and Specificity of the device in relation to the clinical reference standard in the overall study population.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start7 Aug 2019
- Primary completion5 Jun 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will undergo both investigational and comparator diagnosis for ASD.
- Masking
- None (open label)
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognoa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharief Taraman, MD, Study director, Cognoa, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151290
- Sponsor's protocol ID
- Q170886
- Status last verified
- Nov 2021
- First submitted
- 9 Oct 2019
- Last updated
- 28 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognoa ASD Diagnosis Aid Validation Study
- ClinicalTrials.gov ID
- NCT04151290
- Acronym / sponsor ID
- Q170886
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Cognoa, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Posted 28 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will undergo both investigational and comparator diagnosis for ASD.
| Arm | Type | Receives |
|---|---|---|
| Cognoa Assessment | Experimental | Diagnostic Test: Cognoa ASD diagnostic deviceCognoa diagnostic ASD device. |
Who may qualify
- Ages
- 18 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognoa ASD diagnostic deviceCognoa device is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD) | Diagnostic test | Cognoa Assessment |
Primary outcome
Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation
Time frame: 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
Time frame: 6 Weeks
Measurement of the percentage of children for whom the device has provided no result.
1 secondary outcome
Device Sensitivity and Specificity
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharief Taraman, MD study director
Cognoa, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognoa ASD diagnostic device in people with Autism Spectrum Disorder, run by Cognoa, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Predictive Value of ASD Dx in Relation to Clinician Diagnostic Evaluation (time frame: 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.