Cognoa ASD Diagnosis Aid Validation Study
Phase: NA
Conditions: Autism Spectrum Disorder
Sponsor: Cognoa, Inc.

 
 
 
 
 
Protocol Number: 
Q170886 
Protocol Title:  
Cognoa ASD Diagnosis Aid Validation Study 
 
 
NCT Number: 
NCT04151290 
 
Protocol Date: 
Version 3.0, Dated February 3, 2020 
 
 

Cognoa, Inc. 
Protocol # Q170886 
“Cognoa ASD Diagnosis Aid Validation Study” 
 
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TITLE PAGE 
 
 
 
 
Protocol Number: 
Q170886 
Protocol Title:  
Cognoa ASD Diagnosis Aid Validation Study 
Sponsor: 
 
Cognoa, Inc. 
2185 Park Blvd. 
Palo Alto, CA 94306 
Telephone: (408) 207-6659 
Contact: Minda Seal 
Email: minda.seal@cognoa.com 
 
 
Version, Date: 
Version 3.0, Dated February 3, 2020 
 
 
 
 
 
 
Statement of Compliance  
The study will be conducted in accordance with the design and specific provisions of this IRB approved protocol, the ethical principles that 
have their origin in the Declaration of Helsinki, U.S. FDA requirements, including Good Clinical Practice (GCP), and all applicable local, state 
and federal regulations. 
 
 
 
NOTE: The confidential information in the following document is provided to you as an Investigator, potential Investigator, or consultant for 
review by you, your staff, and applicable Institutional Review Board. By accepting this document, you agree that the information contained 
herein will not be disclosed to others without written authorization from Cognoa, Inc. except to the extent necessary to obtain informed 
consent from those persons to whom the device will be administered. 
 
 

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Protocol Signature Page – Principal Investigator 
 
 
 
 
Study Title:  Cognoa ASD Diagnosis Aid Validation Study  
 
 
Protocol Version 3.0, Dated February 3, 2020 
 
I have received and read the protocol dated February 3, 2020 and agree to adhere to the requirements. I am aware 
that my adherence to the above protocol is mandatory and that any changes in the protocol or informed consent 
form must first be approved by Cognoa, Inc. and the Institutional Review Board, except those changes necessary to 
eliminate apparent immediate hazards to subjects. I will provide copies of this protocol and all pertinent information 
to the study personnel under my supervision. I will discuss this material with them and ensure they are fully 
informed regarding their role in the study. I will ensure that the study is conducted in compliance with the protocol, 
Good Clinical Practice (GCP), and all applicable regulatory requirements, and with the reviewing Institutional Review 
Board (IRB) requirements. I agree to commence this study only after documented IRB approval is obtained. 
 
 
Principal Investigator:    _____________________________ 
_________________________ 
 
                             Signature 
 
 
 
 
Date 
 
 
 
 
  _____________________________ 
 
 
                             Printed Name  
 
 
 
 
 
 

Cognoa, Inc. 
Protocol # Q170886 
“Cognoa ASD Diagnosis Aid Validation Study” 
 
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Table of Contents 
Abbreviations 
5 
Glossary 
6 
Protocol Summary 
9 
1 
BACKGROUND INFORMATION 
12 
2 
STUDY DEVICE DESCRIPTION 
14 
3 
STUDY OBJECTIVES 
15 
4 
STUDY ENDPOINTS 
16 
4.1 
Effectiveness endpoints 
16 
4.2 
Safety endpoints 
16 
5 
STUDY DURATION 
16 
6 
STUDY DESIGN AND PROCEDURES 
16 
7 
STUDY POPULATION 
19 
7.1 
Study Subject Recruitment and Selection 
19 
7.2 
Inclusion Criteria 
20 
7.3 
Exclusion Criteria 
20 
7.4 
Subject Number 
21 
7.5 
Subject Discontinuation Criteria 
21 
8 
DATA COLLECTION AND STORAGE 
21 
9 
ADVERSE EVENTS AND ADVERSE DEVICE EVENTS 
22 
9.1 
Definitions 
22 
9.1.1 
Adverse Event (AE) 
22 
9.1.2 
Serious Adverse Event (SAE) 
22 
9.1.3 
Anticipated Serious Adverse Device Effect (ASADE) 
23 
9.1.4 
Unanticipated Serious Adverse Device Effect (USADE) 
23 
9.2 
Recording AEs/ADEs and SAEs/SADEs 
25 
9.3 
Follow-up of Subjects after AEs 
25 
10 
POTENTIAL RISKS / BENEFITS 
25 
10.1 
Potential Risks 
25 
10.2 
Potential Benefits 
25 
11 
DATA ANALYSIS PLAN 
26 
11.1 
Sample Size 
26 
11.2 
Analysis Sets 
26 
11.3 
Statistical Analyses 
26 
11.4 
Safety Analyses 
26 
 
 

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12 
STUDY MANAGEMENT AND ADMINISTRATIVE CONSIDERATIONS 
26 
12.1 
Investigator Selection 
26 
12.2 
Training and Monitoring 
26 
12.3 
Informed Consent 
26 
12.4 
Protocol Compliance 
27 
12.5 
Protocol Amendments 
27 
12.6 
Protocol Deviation 
27 
12.7 
Study Discontinuation 
27 
12.8 
Data Collection, Record Keeping and Storage 
27 
12.9 
Subject Confidentiality 
27 
12.10 
Financial Considerations 
28 
REFERENCES 
29 
APPENDIX - STANDARDIZED MEDICAL HISTORY AND PHYSICAL FORM 
31 
 
 
 
 

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Abbreviations 
 
ADHD:   
Attention Deficit Hyperactivity Disorder 
ADI-R:  
Autism Diagnostic Instrument Revised 
AE: 
 
Adverse Event 
AGRE:  
Autism Genetic Resource Exchange 
ASADE:  
Anticipated Serious Adverse Device Effect 
ASD:  
 
Autism Spectrum Disorder 
ASRS:  
Autism Spectrum Rating Scales 
BRIEF:  
Behavior Rating Inventory of Executive Functions 
CFR:  
 
Code Federal Regulation 
CRF: 
 
Case Report Form 
DSM-5:  
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition 
FDA: 
 
Food and Drug Administration 
GCP: 
 
Good Clinical Practice 
HCP: 
 
Healthcare Provider 
HIPAA:  
Health Insurance Portability and Accountability Act of 1996 
ICH: 
 
International Conference on Harmonization 
IRB: 
 
Institutional Review Board 
JAMIA:  
Journal of the American Medical Informatics Association 
M-CHAT-R: 
Modified Checklist for Autism in Toddlers-Revised 
NPV: 
 
Negative Predictive Value 
PII: 
 
Personally Identifiable Information 
PPV: 
 
Positive Predictive Value 
SAE: 
 
Serious Adverse Event 
SRS: 
 
Social Responsiveness Scale 
USADE:  
Unanticipated Serious Adverse Device Effect 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Glossary 
 
Term 
Definition 
Accuracy (error rate) 
Rate of correct (incorrect) predictions made by the model over a 
data set. Accuracy is usually estimated by using an independent test set 
that was not used at any time during the learning process. 
ADI-R 
The Autism Diagnostic Interview-Revised (ADI-R) is a structured interview 
conducted by an experienced clinical interviewer questions a parent or 
caretaker who is familiar with the developmental history and current 
behavior of the individual being evaluated and uses standardized 
procedures to code the responses. The interview can be used to assess 
children and adults as long as their mental ages are two years or higher. 
Because the ADI–R is an interview rather than a test, and because it 
focuses on behaviors that are rare in non-affected individuals, it provides 
categorical results rather than scales or norms. 
ADOS 
The Autism Diagnostic Observation Schedule (ADOS) is a semi- structured 
assessment of communication, social interaction, and play (or imaginative 
use of materials) for individuals suspected of having autism or other 
pervasive developmental disorders. Its goal is to provide standardized 
contexts in which to observe the social-communicative behaviors of 
individuals across the life span in order to aid in the diagnosis of autism 
and other pervasive developmental disorders. Administration and coding 
are highly standardized. Therefore, valid assessment requires training.  
Aid to Diagnosis 
Output that provides a Healthcare Provider (HCP) information that 
drives a diagnosis. An Aid to Diagnosis is not a standalone diagnosis tool. 
Algorithm 
A process or set of rules to be followed in calculations or other problem-
solving operations, especially by a computer. The Device has an 
underlying algorithm based on machine learning 
techniques that provides the output to the provider. 
ASD 
Autism Spectrum Disorder 
Caregiver 
The caregiver is often the parent of the child presenting ASD symptoms 
but may represent the legal guardian or adult in charge of the child’s well-
being and healthcare decisions. 
Clinical reference 
standard 
Best available method for establishing a subject’s true status with 
respect to a target condition. 
(Machine learning) 
Classification 
Process of predicting to which predefined category (or class/label) a new 
observation belongs, on the basis of a training set of data 
containing observations whose category membership is known. 
Classifier 
Algorithm that evaluates unlabeled data and classifies them. 
 
 
 
 
 

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Term 
Definition 
Cognoa Research App 
A smartphone-based app that describes the Cognoa device, provides 
guidance on and access to assessments and video software, and serves as 
a collection mechanism for assessments and videos. 
Coverage 
Proportion of a data set for which a classifier makes a prediction. 
Diagnostic Output 
Output from the Cognoa Device that is used as part of an overall 
diagnosis decision. 
Dropout 
After consenting to participation in trial (and therefore enrolling), a study 
subject discontinues participation in the trial (e.g., due to lack of interest, 
medical condition, adverse event). Dropout may simply be lost to follow 
up. 
DSM-5 
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; a 
guide to clinicians for diagnosis of neurobehavioral and 
psychiatric disorders. 
Endpoint 
Key outcome measure in a clinical study. 
Feature 
Individual measurable property or characteristic of an observation. 
Futility 
Situation in which proceeding further with a trial is not safe, feasible, or 
warranted from a statistical perspective. Studies can be stopped early due 
to unacceptable safety or risk/benefit profile, inability to recruit or 
perform study procedures, overwhelming 
early efficacy, or statistical impossibility of achieving endpoint(s). 
HCP 
Healthcare provider. 
IC / ICF 
Informed consent / Informed consent form. 
IRB 
Institutional review board. 
Negative Predictive Value 
Probability that a child identified by the device as Negative for ASD truly 
doesn’t have ASD 
NPV = (True Negative)/ (True Negative + False Negative) 
Positive Predictive Value 
Probability that a child identified by the device as Positive for ASD truly 
has ASD 
PPV = (True Positive)/ (True Positive + False Positive) 
Prevalence 
Number of cases in a defined population at a single point in time, 
regardless of when they first developed the condition. 
Prevalence = (# of cases in sample with condition) / (total # of cases in 
sample) 
Screening tool 
A tool used in assist in clinical triage. 
 
 
 
 
 
 

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Term 
Definition 
Sensitivity 
Measure of the proportion of children truly having ASD who are correctly 
identified by the device as Positive for ASD (or True positive rate). 
Sensitivity = (True Positive)/ (True Positive + False Negative) 
Specificity 
Measure of the proportion of children truly not having ASD who are 
correctly identified by the device as Negative for ASD (or True negative 
rate). 
Specificity = (True Negative)/ (True Negative + False Positive) 
Specialist Clinician 
Board-certified child adolescent psychiatrists, child neurologists, 
developmental-behavioral pediatricians, or psychologists, and have at 
least five years of experience in diagnosing and treating individuals with 
ASD. 
Standalone/ primary 
diagnostic device 
A device that outputs a primary diagnosis that is intended to be 
the sole source of input into clinical-decision making, absent any 
interaction with a clinician. 
Standard of care 
Current practice of care 
Video Analyst 
A trained healthcare professional who reviews Module 2 (Video Analysis 
module) videos submitted by caregivers to provide responses on the 
patient’s behaviors and actions. 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 

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Protocol Summary 
 
Title 
Cognoa ASD Diagnosis Aid Validation Study 
Sponsor 
Cognoa, Inc. 
Study Description 
This study seeks to evaluate the ability of the fourth generation Cognoa 
ASD Diagnosis Aid (the “device”) to aid healthcare providers in 
diagnosing autism spectrum disorder (ASD).  Children age >18 to <72 
months for whom the caregiver or a healthcare provider has concern 
regarding developmental delay will be assessed with the device in a 
prospective, blinded, multi-site, active comparator, cohort study. The 
output of the device will be compared to a specialist clinician diagnosis 
based on DSM-5 criteria, validated with independent review by one or 
two central specialist clinicians. 
 
For enrollment into the study, informed consent will be obtained from 
the subject’s legal guardian. The subjects’ caregivers will complete a 
caregiver assessment and upload two brief videos of the child for 
analysis prior to their evaluation by a specialist clinician. All participants, 
subjects’ caregivers and HCPs, will be blinded to the results of the 
device. Furthermore, the caregivers, device video analysts, and HCPs 
providing inputs to the device algorithm will be blinded to each other’s 
input. 
Objective 
 
To assess the ability of the 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. 
Endpoints 
Primary: 
● 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. 
● Measurement of the proportion of children for whom the 
Device provides no result.    
 
Secondary: 
● Sensitivity of the device in relation to the clinical reference 
standard in the overall study population. 
● Specificity of the device in relation to the clinical reference 
standard in the overall study population. 
 
Safety Assessment 
Adverse events (AEs) and serious adverse events (SAEs) will be 
collected and reported 

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Study Design 
This is a multi-site, prospective, blinded, active comparator cohort study 
Exempt Device Study 
This study is exempt from the requirements of the IDE regulations (21 
CFR 812.2 (c)), with the exception of 21 CFR 812.119 Disqualification of a 
Clinical Investigator. 
 
In accordance with 21 CFR 809.10(c), the device labeling shall include 
the following statement: "For Investigational Use Only. The performance 
characteristics of this product have not been established." 
Number of Sites 
The study will be conducted at up to 30 clinical sites within the United 
States. 
Principal Investigator 
To be determined 
Study Sample Size 
Up to 725 subjects 
Subject Population 
Female and male subjects between the ages of ≥ 18 months of age and < 
72 months of age from a general population for whom a caregiver or 
healthcare provider has a concern about developmental delay. 
Inclusion/Exclusion 
Criteria  
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. 
● Functional English capability in the home environment. 
● Caregivers must have smartphone capabilities for downloading 
the Cognoa Research App (Cognoa supports iOS 10.0 and up, 
Android 6.0 and up). 
● Participants must be willing to be videotaped as part of the 
diagnostic assessment by the specialist clinician.  
 
Exclusion Criteria: 
● Subjects with a prior diagnosis of ASD rendered by a healthcare 
professional. 
● Subjects with suspected auditory or visual hallucinations or with 
prior diagnosis of childhood onset schizophrenia. 
● Subjects with deafness or blindness. 
● Subjects with known physical impairments affecting their ability 
to use their hands. 
● Subjects with major dysmorphic features or prenatal exposure 
to teratogens (such as fetal alcohol syndrome). 
● Subjects with history, suspicion, or diagnosis of genetic 
conditions (such as Rett’s Syndrome or Fragile X) 
● Subjects with microcephaly. 
● Subjects with history or prior diagnosis of epilepsy or seizures. 
● Subjects with a history of neglect. 

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● Subjects with a history of brain malformation, injury or insult 
requiring interventions such as surgery or chronic medication. 
● 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. 
● Subjects whose medical records had been included in any 
internal Cognoa training or validation sets. 
Planned Schedule 
First subject enrolled:  August 2019 
Study Duration 
10 Months 
Duration of Subject 
Participation 
The duration of each individual subject’s involvement in the study will 
be approximately 6 weeks.  
Investigational and 
Control Diagnoses 
Investigational: Cognoa device diagnostic output.  
Comparator: Specialist clinician diagnosis of ASD, validated by one or 
more central reviewing specialist clinicians. 
Randomization 
None. All subjects will be scheduled to undergo both investigational and 
comparator diagnosis for ASD. 
 
 

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1 
BACKGROUND INFORMATION 
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder that affects communication and behavior. 
 
According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), a guide created by 
the American Psychiatric Association and used by health care professionals to diagnose mental disorders, ASD 
primarily consists of persistent deficits in social communication and social interaction as well as the presence of 
restricted, repetitive patterns of behaviors, interests, and/or activities that can persist throughout life. 
 
ASD is said to be a “developmental disorder” because symptoms generally appear in the first two years of life and 
is known as a “spectrum” because there is a wide variation in the type and severity of symptoms people 
experience. 
 
Symptoms can include poor eye contact, difficulty reading social cues, failure to develop peer relationships, lack of 
social or emotional reciprocity, delayed speech development, difficulty sustaining conversations, lack of make-
believe play, repetitive motor mannerisms, rigid adherence to routines, restricted interests and hyper- and/or 
hypo sensitivity to sensory input. ASD can have a significant impact on a child’s day-to-day functioning including 
but not limited to impairments in communicating and getting needs met as well as difficulties with activities of 
daily living such as eating, dressing, playing, and sleeping. 
 
Reported prevalence rates have been rising steadily since the 1960s and Autism Spectrum Disorders have risen to 
the top of childhood disorders with a prevalence rate of 1 in 59 children (Baio, Wiggins, Christensen et al., 2018). 
Multiple environmental, biologic, and genetic factors contribute to the development of ASD (Landrigan, 2010; 
Hallmayer, Cleveland, Torres, et al., 2011; Gaugler, Klei, Sanders, et al., 2014; Pinto, Pagnamenta, Klei, et al., 
2010). Also, ASD is reported to occur in all racial, ethnic, and socioeconomic groups, and is approximately 4 times 
as prevalent in boys than girls. 
 
As recognized by the Center for Disease Control (CDC), diagnosing ASD can be difficult, since there is no medical 
test, like a blood test, to diagnose the disorder. Healthcare professionals typically diagnose ASD by observing how 
the child talks and acts in comparison to other children of the same age and by asking questions to caregivers. 
They use the standardized diagnostic criteria for ASD provided in the American Psychiatric Association’s Diagnostic 
and Statistical Manual, Fifth Edition (DSM-5) and focus on the assessment of a behavioral phenotype, including 
deficits in social communication, social interactions, and restricted or repetitive behaviors while also considering 
the developmental history as well as the alternate developmental diagnosis that would explain the symptoms.
 
The American Academy of Pediatrics recommends children be screened specifically for Autism at 18 and 24 
months, or whenever caregivers express concern. The standard practice for screening is the Modified Checklist for 
Autism in Toddlers-Revised (M-CHAT-R). Many studies show, however, that primary HCPs are not screening 
children for ASD per these recommendations due to lack of confidence in the tools and/or lack of time to properly 

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review results with caregivers (Carbone et. al, 2016). If a primary care provider does suspect a developmental 
delay such as ASD, children are often put on watchful waiting until the clinician can be more certain of a problem. 
Moreover, in cases in which a referral for an assessment by a specialist is eventually provided, families may wait 
as long as 18 months between initial screening by their primary HCP and final diagnosis by the specialist, or even 
longer if the family is part of a minority population or lower socioeconomic group (Begeer, Bouk, Boussaid, 
Terwogt, & Koot, 2009). On average, the overall delay between first concerns arising in caregivers and an ASD 
diagnosis is approximately 3 years (Zuckerman, Lindly, & Sinche, 2015). 
 
This delay in obtaining a diagnosis directly translates into delays in initiating early behavioral intervention. Such 
early intervention in ASD has been shown to have significant positive impact on a child’s development, especially 
when delivered before 36 months (Warren et al., 2011). 
 
Although families report concerns to their child’s physician as early as 1 year of age, the average age of diagnosis 
in the United States is 4.4 years old and an estimated 27% of children with ASD still remain undiagnosed at 8 years 
of age. At later stages in development, many of the early intervention opportunities have passed. Delayed 
therapies are much less effective, and the delay can impact child learning and development creating lifelong 
disability, not to mention the related increased economic costs on caregivers and society (Dawson et al, 2009; 
Cidav, et al., 2017). Thus, there is a critical need to provide primary HCPs not only with tools to screen and triage 
children for ASD, but also tools that can provide them with higher levels of diagnostic certainty than are currently 
available in the primary care setting, thus enabling them to render a diagnosis without referral to a specialist. 
 
Currently there are no FDA cleared or approved medical devices intended to aid in the diagnosis of ASD. 
Behavioral instruments with the highest diagnostic validity, such as the Autism Diagnostic Observation Schedule 
(ADOS) (Lord et al., 2000) and the Autism Diagnostic Instrument Revised (ADI-R) (Lord, Rutter, & Couteur, 1994) 
are typically delivered in a secondary care setting and can take several hours to administer by a trained specialist. 
The geographic and logistical hurdles in finding a healthcare professional trained to administer these instruments, 
the long duration of the standard exams, as well as the need for administration in a clinical facility, contribute to 
delays in diagnosis and an imbalance in coverage of the population needing attention (Shattuck PT, Durkin M, et 
al. 2009). 
 
Rural communities face even more significant challenges regarding the availability of diagnostic specialists and 
geographic distance and transportation challenges, which results in delayed diagnosis of ASD, and consequently 
lower outcomes for children in these communities (Antezana, Scarpa, Valdespino, Albright, & Richey, 2017).
 
To address these challenges, Dr. Dennis Wall (scientific founder of Cognoa), then at the Center for Bioinformatics 
at Harvard Medical School, used machine learning techniques to create a 7- question classifier, which stems from 
machine learning research on answers to elements in the ADI-R, an interviewer-based examination administered 
by a trained clinician to a parent or care provider about autism symptoms, which can take between 2 and 5 hours 
to complete. Dr. Wall’s Lab used data from Autism Speaks’ Autism Genetic Resource Exchange (AGRE) to create 
the classifier and then used this same database, in addition to two independent sources (a collection of 1654 

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autistic individuals from the Simons Foundation and a collection of 322 autistic individuals from the Boston Autism 
Consortium), to show a high level of statistical accuracy in correctly classifying children with ASD. The classifier 
was 92% accurate in identifying those who do not have ASD (Wall, Dally, Luyster, Jung, & DeLuca, 2012). 
 
Dr. Wall and his colleagues continued to apply the techniques of machine learning to each of the observational 
modules of the ADOS. The ADOS is a semi-structured observational tool administered by a trained clinician that is 
focused on first-hand observations of the child. The ADOS module that is administered is determined by the 
child’s level of language (i.e. nonverbal, single words, phrased speech, fluent speech). By generating classifiers for 
each of the modules separately, Dr. Wall was able to adjust the risk generator to accommodate children across 
the developmental spectrum. He was able to again validate his findings in independent samples and showed a 
high degree of sensitivity and specificity in these archival datasets (Duda, Kosmicki, & Wall, 2014; Kosmicki, 
Sochat, Duda, & Wall, 2015). 
 
Building on the work of Dr. Dennis Wall, Cognoa has further developed the algorithm/software to render a risk 
assessment for Autism. Cognoa’s first-generation algorithm, developed in 2015 for screening purposes, showed 
better accuracy across a broader age range than other screening tools in a clinical study published in Autism 
Research (Kanne, Carpenter, & Warren, 2018). Cognoa has continued to advance the development of its machine 
learning platform as the basis for a reliable diagnostic device to improve the timeliness of autism diagnosis within 
the critical early childhood years (Abbas H., Garberson F., Glover E., Wall D. 2018). 
   
 
2 
STUDY DEVICE DESCRIPTION 
 
The Study Device (“Device”) is intended to aid healthcare providers in diagnosing Autism Spectrum Disorder (ASD) 
for children ≥ 18 months of age and < 72 months of age who are at risk for developmental delays based on a 
parental or healthcare provider concern. 
 
The device is not intended for use as a stand-alone diagnostic device. It is intended to be used in conjunction with 
the clinical presentation of the patient.  
 
The Device comprises of the following: 
● A caregiver facing mobile application (Cognoa Research App) 
● A Video Analyst Portal 
● Healthcare Provider Assessment 
● Underlying machine learning algorithm that drives the Device outputs (“Algorithm”) 
 
 
 
 
 
 
 

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The Algorithm operates on information and data from three modules, that serve as data input. 
 
Device Module 
Module Description 
Delivery System 
Module 1 - Caregiver Assessment 
Answers to questions on key 
developmental behaviors (by age 
group), provided by the child’s 
caregiver. 
Caregiver responses will be 
submitted via Cognoa Research 
App 
Module 2 - Patient Video Analysis 
Information provided by trained 
video analyst who reviewed videos 
of the child’s natural play, 
communication, and social 
behavior at home, provided by the 
child’s caregiver. 
Caregiver will submit videos via 
Cognoa Research App 
 
Video analysts will access, review, 
and provide information via Video 
Analyst Portal 
Module 3 - Healthcare Provider 
Assessment 
Answers to questions on key 
developmental behaviors (by age 
group), provided by the child’s 
healthcare provider. 
Healthcare provider responses will 
be captured on a form via pen and 
paper.  
 
Study Staff data entry personnel 
will enter information from form 
into a study database.   
 
The device evaluates the data inputs based on key developmental behaviors that are most indicative of autism 
and provides the following outputs -- Positive for Autism Spectrum Disorder (Positive ASD) or Negative for Autism 
Spectrum Disorder (Negative ASD).  The device output will be recorded by Sponsor in a dedicated study data 
repository. It will not be shared with the referring HCP, caregivers, or specialist clinicians performing diagnosis and 
review. 
 
3 
STUDY OBJECTIVES 
This study seeks to evaluate the ability of the 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. 
 
This is a multi-site, prospective, blinded, active comparator, cohort study in up to 725 subjects, ages ≥ 18 months of 
age and < 72 months of age. 
 
 
 

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4 
STUDY ENDPOINTS 
4.1 
Effectiveness endpoints 
 
The primary endpoints of this study are: 
(1) to achieve 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, and 
(2) measurement of the proportion of all children for whom the Device provides no result. 
 
The secondary endpoints are: 
(1) sensitivity of the device in relation to the clinical reference standard in the overall study population and  
(2) specificity of the device in relation to the clinical reference standard in the overall study population. 
   
4.2 
Safety endpoints  
Adverse events (AEs) and serious adverse events (SAEs) will be collected and reported from enrollment (informed 
consent signature) through completion of the reference diagnosis clinic visit. 
 
5 
STUDY DURATION 
The study is expected to last 6 months. Subjects’ participation in the study is expected to last 6 weeks. 
 
6 
STUDY DESIGN AND PROCEDURES 
Primary healthcare providers who identify children at risk for developmental delay or learn of caregiver concern 
about developmental delay will inform caregivers about the clinical study. Caregivers may have access to a 
research coordinator, study website, or app (Cognoa Research app) to learn more about the study, provide 
consent, determine whether their child qualifies, and answer questions to test their comprehension of the study.  
 
All subjects will undergo investigational (Cognoa assessment) and comparator diagnostic assessments for ASD 
using DSM-5 criteria and validating central review.  Caregivers will be instructed to download the Cognoa 
Research app on their smartphone, set the username and password, complete a caregiver assessment about the 
child’s behavior and development, and record two brief videos of their child. Caregivers will be given guidance on 
how to record videos. Both the assessment and the videos will be submitted via the Cognoa Research app. Cognoa 
video analysts will analyze the videos. The primary healthcare provider (HCP) will also answer an assessment 
about the child’s behavior and development. The caregivers, video analysts, and HCPs providing inputs to the 
device algorithm will be blinded to each other’s input. 
 
Once the caregiver assessment, primary HCP assessment, and scored videos have been submitted, the device will 
generate a diagnostic output. The device output will be recorded by the Sponsor in a dedicated study data 
repository. The device inputs and the device output will not be shared with the referring HCP, caregivers, or 

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specialist clinicians performing diagnosis and review. 
 
After the caregiver assessment has been completed and scorable videos submitted, the caregiver will be 
contacted by a research coordinator to schedule an appointment for a diagnostic evaluation by a specialist 
clinician. The specialist clinician will meet with the child and caregiver(s), conduct an assessment (which will be 
captured on video), and make a diagnosis of positive for ASD or negative for ASD based on DSM-5 criteria. The 
outcome of the diagnostic encounter may not be “uncertain” or “unknown at this time”.  The diagnosing clinician 
will also complete a standardized medical history and physical form (See Appendix), which may be completed 
during the diagnosing clinician visit.  The standardized form and video will be sent to the Cognoa study monitor. 
 
Determination of clinical diagnosis for study analysis purposes (clinical reference standard) will consist of a 
specialist clinician diagnosis by DSM-5 criteria, validated with independent review by one or two central specialist 
clinicians. After the diagnosing clinician has completed the patient assessment, the patient case is reviewed by 
one reviewing specialist clinician (who is provided with the standardized medical history and physical form, and a 
video of the diagnostic encounter). The diagnosing clinician will be instructed to not state any diagnostic 
conclusion, decision on any particular component of DSM-5 criteria, or diagnostic observation during the video of 
the assessment. If the assessment of the reviewing specialist clinician agrees with that of the diagnosing clinician, 
the diagnosis is considered validated and no further validation is conducted.   If the reviewing specialist clinician 
disagrees with the diagnosing clinician, then the case is referred to a second reviewing specialist clinician.  The 
study monitor will track reviewing clinicians' assessment results, maintaining blinding to all parties. The diagnosis 
for study analysis purposes is taken as the majority assessment of the three specialists (one diagnosing specialist 
and two reviewing specialists). 
 
Subjects Identification and Recruitment 
If the primary HCP has identified a child at risk for developmental delay or learns of caregiver concern about 
developmental delay the primary HCP or a member of his or her clinical team will inform caregivers about the 
study. Caregivers will be provided with material(s) describing the study and how to learn more and enroll. 
Caregivers may be enrolled in the study by Study Staff, if available at the site, via a website, or the Cognoa 
Research app.  If caregivers have questions, they can direct them to their primary HCP or his/her staff assisting in 
the study. They can also contact the Sponsor’s representative for the study. If the caregivers wish to pursue 
enrollment for their child, they will answer questions to determine if the inclusion/exclusion criteria are met.  This 
will determine eligibility of the child for the study. 
 
Process of Consent 
The caregivers of the child will be given access to the consent form. The objective of the informed consent form is 
to ensure that they understand the purpose of the study, the risks and benefits of participating and the voluntary 
nature of their participation. If they have questions, they may reach out to their primary HCP, other research staff 
at the site, or the Sponsor’s study coordinator. A child will not be enrolled in the study if his/her caregivers do not 
sign the consent. Child assent is not needed as the child involved will be less than 6 years old. Study subjects can 
end their participation in the study at any time. 

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Randomization 
No randomization is necessary. This is a cohort single-arm study, with all subjects scheduled to undergo both 
investigational (Cognoa assessment) and diagnostic assessment for ASD using DSM-5 criteria and validated by one 
or two reviewing specialist clinicians. 
 
Study Flow 
Caregivers of subjects who have enrolled in the study will be instructed to download the Cognoa Research app, if 
they have not already done so, onto their smartphone, set a username and password, complete the caregiver 
assessment, and record two brief videos of their child for the video analysis portion of the assessment. Both the 
caregiver assessment and videos will be submitted via the Cognoa Research App. 
 
The videos will be uploaded securely to a HIPAA secure server. Each submission will be scored by analysts who 
evaluate behaviors observed by answering a series of multiple-choice questions evaluating phenotypic features of 
ASD (e.g., on-verbal and verbal communication; social interaction; unusual sensory interests/reactions; 
stereotyped or repetitive motor movements, use of objects, or speech) on the combinative videos.  
 
The videos analysts scoring the videos submitted for study purposes will have at least a Master’s Degree from 
professional backgrounds including psychology, occupational therapy, physical therapy, speech-language 
pathology, special education, or a related field with specific training in autism diagnosis and/or treatment. They 
will also have at least 5 years of professional and/or clinical experience working with children with ASD. They will 
be trained, qualified to score the videos and their performance will be monitored according to Cognoa’s 
procedures. 
 
The video analysts will not have access to the caregiver assessment or the primary HCP assessment. If the videos 
are not scorable (e.g., if one or more videos are unhelpful for any reason such as: poor lighting, poor video or 
audio quality, bad vantage point, child not present or identifiable within a group, insufficient interaction with the 
child), the caregiver will be asked to submit additional videos. Caregivers will be allowed a maximum of 60 days 
from submitting the caregiver assessment (Module 1) to complete video upload or provide scoreable videos.  
Caregivers will be given guidance points on how to record videos.  
 
Either during the primary care appointment when the patient was informed about the study or in a timely manner 
after the appointment, the primary care physician will answer the primary HCP assessment about the child’s 
behavior and development. The clinician will only answer the assessment if the caregiver provides an initial 
consent.  If the caregiver chooses not to participate in the study, the primary HCP assessment will be securely 
destroyed. The HCP will not have access to the responses in the caregiver assessment (Module 1), the patient 
videos, or the video’s analysis (Module 2). 
 
Once the caregiver assessment, primary HCP assessment, and scored videos have been submitted, the device will 
generate a diagnostic output. The device output will be recorded by Sponsor in a dedicated study data repository. 

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“Cognoa ASD Diagnosis Aid Validation Study” 
 
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It will not be shared with the referring HCP, caregivers, or specialist clinicians performing diagnosis and review. 
 
After the caregiver assessment has been completed and scorable videos submitted, the caregiver will be 
contacted by a research coordinator to schedule an appointment for a diagnostic evaluation by a specialist 
clinician.  The subjects will be randomized to one of the specialist clinicians in the study at their respective site.  
The specialist clinician will meet with the child and caregiver(s), fill out a standardized form for medical history and 
physical information (and may ask caregivers to fill out parts of this form during the visit) (See Appendix), conduct 
an assessment, and make a diagnosis for ASD. He/she will utilize clinical observation, clinician interview and exam, 
medical record review, and assessment instruments as he or she deems necessary to arrive at a diagnosis based 
on DSM-5 criteria, positive for ASD or negative for ASD. The diagnosing specialist clinician will be provided with a 
standardized protocol to use for a portion of the recorded diagnostic encounter (this video is a unique video 
unrelated to the videos uploaded by the caregiver in the App (Module 2)).  This recorded interaction includes 
standard approaches to eliciting behavior (e.g., asking child to blow bubbles or speak on toy phone). The 
diagnosing clinician will be instructed to not state any diagnostic conclusion, decision on any particular component 
of DSM-5 criteria, or diagnostic observation during the video of the assessment. 
 
Any further diagnostic testing deemed necessary by the clinician will be included as part of the study records. 
Diagnosis of ASD alone or ASD plus co-morbid condition(s) would both constitute a positive for ASD clinical 
evaluation. If the clinician determines that the patient is negative for ASD and is able to arrive at a diagnosis other 
than ASD or determine that the patient is neurotypical, that data will also be captured.   
 
The completion of diagnostic assessment by the diagnosing specialist clinician will indicate the conclusion of the 
subject’s involvement in the study. 
 
Determination of clinical diagnosis for study analysis purposes (clinical reference standard) will follow a staged 
sequential review, in which a specialist clinician diagnosis by DSM-5 criteria will be validated with independent 
review by one or two central reviewing specialist clinicians. The purpose of this approach is to mitigate against any 
excessive variability in the clinical diagnostic process. Specialist clinicians will be board-certified child adolescent 
psychiatrists, child neurologists, developmental-behavioral pediatricians, or psychologists, and will have at least 
five years of experience diagnosing autism spectrum disorder.     
 
For clinical care purposes, at the end of subject participation in the study, any findings will be shared with the 
caregiver by the study site. 
 
7 
STUDY POPULATION 
 
7.1 
Study Subject Recruitment and Selection 
This study will enroll up to 725 male or female subjects, between the ages of ≥ 18 months of age and < 72 months 
of age from multiple recruitment sites. 

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Subjects may also be recruited from the Investigator’s existing patient database or from patients who present 
themselves to the study site requesting evaluation.  
 
Only subjects who meet all eligibility criteria and who provide informed consent will be enrolled into the study. 
 
Each subject will be evaluated by the primary HCP to assess his/her suitability for entry into the study according to 
the following inclusion and exclusion criteria. 
  
7.2 
Inclusion Criteria 
To be included in the study, subjects must meet all of the following 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. 
● 
Functional English capability in the home environment. 
● 
Caregiver must have smartphone capabilities for downloading the Cognoa Research App (Cognoa supports 
iOS 10.0 and up, Android 6.0 and up). 
● 
Participants must be willing to be videotaped during the diagnostic assessment by the specialist clinician.  
 
7.3 
Exclusion Criteria 
Subjects will be excluded from the study if they meet any of the following Exclusion Criteria: 
● 
Subjects with a prior diagnosis of ASD rendered by a healthcare professional. 
● 
Subjects with suspected auditory or visual hallucinations or with prior diagnosis of childhood onset 
schizophrenia. 
● 
Subjects with deafness or blindness. 
● 
Subjects with known physical impairments affecting their ability to use their hands. 
● 
Subjects with major dysmorphic features or prenatal exposure to teratogens (such as fetal alcohol 
syndrome). 
● 
Subjects with history, suspicion, or diagnosis of genetic conditions (such as Rett’s Syndrome or Fragile X) 
● 
Subjects with microcephaly. 
● 
Subjects with history or prior diagnosis of epilepsy or seizures. 
● 
Subjects with a history of neglect. 
● 
Subjects with a history of brain malformation, injury or insult requiring interventions such as surgery or 
chronic medication. 
● 
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. 
● 
Subjects whose medical records had been included in any internal Cognoa training or validation sets. 

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7.4 
Subject Number 
If a caregiver completes the Informed Consent Form, meets the study eligibility criteria and is willing to 
participate, the subject will be assigned a study subject identification number.  
 
This subject identification number will have no relation to Personally Identifiable Information (PII, defined as any 
data that could potentially identify a specific individual), such as date of birth, initials, medical record number, etc.  
All data transmitted and used for analysis will be identified by ID number and not subject identifying information.  
 
7.5 
Subject Discontinuation Criteria 
If possible, every subject should remain in the study until completion of the required follow-up period. However, 
participation in this study is completely voluntary and a subject can choose to withdraw from the study at any 
time.  Decision to withdraw will not affect or prejudice the subject’s continued medical care in any way. In those 
instances, the investigator will attempt to obtain a final clinical assessment and an adverse device effect 
evaluation for the subject prior to this withdrawal. A subject will be considered lost to follow-up only after three 
unsuccessful, documented attempts to contact the subject have been made.   
 
In addition, a subject can be discontinued for any of the following reasons: the Principal Investigator decides that 
continuing in the study would not be in the subject’s best interest, a subject is noncompliant with the protocol, a 
subject has a serious reaction to the treatment, a subject develops any of the exclusion criteria during the study 
period or the study is stopped by the study sponsor. 
 
 
8 
DATA COLLECTION AND STORAGE 
To maintain confidentiality, subjects will be assigned a unique subject ID number (see section 7.4 subject number), 
which will be used on all case report forms and linked to the Informed Consent Forms for audit and verification 
purposes.  All data transmitted and used for analysis will be identified by ID number rather than subject-
identifying information. 
 
Authorized representatives of institutions participating in the study, the Food and Drug Administration (FDA), the 
Sponsor, and the reviewing IRB and other groups or organizations that have a role in this study will have access to 
and may view a subject’s study information. They will be subject to regulations protecting patient confidentiality 
(e.g., HIPAA). 
 
Data collection will be completed using electronic and/or paper report forms provided by the Sponsor, and data 
will be recorded into the Sponsor dedicated study data repository. 
 
 
 

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Data repository will include: 
● 
Demographic information (child age, child biological sex, child race, child ethnicity, caregiver level of 
education) 
● 
Device Inputs 
o Caregiver assessment 
o Video analysis 
o Primary HCP assessment 
● 
Device Output
● 
Diagnostic assessment for ASD according to DSM-5 diagnostic criteria, by the diagnosing specialist clinician  
● 
Medical, Developmental history and Physical  
● 
Diagnostic review outcome of reviewing specialist clinicians 
 
The data will be stored securely on an Amazon S3 cloud server with secured access and SSL encryption. Any data 
collected on paper will be kept in a secure and locked location at the primary HCP’s or specialist clinician’s office 
and periodically transferred to a central research coordinator at each site, before being recorded in an electronic 
format by the study staff and stored on a HIPAA-secure server. 
 
All data will be retained for at least 7 years from the completion of the Study. Data collected on paper may be 
retained solely in electronic format.  
 
9 
ADVERSE EVENTS AND ADVERSE DEVICE EVENTS 
9.1 
Definitions 
9.1.1 
Adverse Event (AE) 
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, device users or other persons, whether or not it 
is related to the investigational medical device.  Expected Adverse Device Events (ADEs) may be previously 
identified in nature, incidence, severity or outcome in the study protocol, informed consent document, device 
operator manual, other risk analysis documentation or regulatory application. 
 
9.1.2 
Serious Adverse Event (SAE) 
A serious adverse event (SAE) is any adverse event, whether related to the use of an investigational device or 
clinical study device, that: 
 
● 
led to a death; 
● 
led to a serious deterioration in the health of the subject that:  
o resulted in a life-threatening illness or injury; 
o resulted in a permanent impairment of a body structure or body function; 
o required in-patient hospitalization or prolongation of existing hospitalization; 

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o resulted in medical or surgical intervention to prevent permanent impairment to a body structure or a 
body function; 
● 
led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
9.1.3 
Anticipated Serious Adverse Device Effect (ASADE) 
An anticipated serious adverse device effect (ASADE) is any SAE on health or safety or any life-threatening 
problem or death caused by, or associated with the device, if that effect, problem, or death was previously 
identified in nature, severity, or degree of incidence in the investigational plan, informed consent, operator 
manual, other risk analysis documentation or regulatory application; or any other serious problem associated with 
a device that relates to the rights, safety, or welfare of subjects.  
 
9.1.4 
Unanticipated Serious Adverse Device Effect (USADE) 
An unanticipated serious adverse device effect (USADE) is any SAE on health or safety or any life-threatening 
problem or death caused by, or associated with the device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the investigational plan, informed consent, operator 
manual, other risk analysis documentation, or regulatory application; or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects.  
 
In subjects, the ADEs/SADEs include the effects related to the investigational medical device (clinical study device), 
or the procedures involved. For device users or other persons (other clinical staff in the treatment room) 
ADE/SADE is restricted to the effects related to investigational medical devices. ADEs/SADEs may include the 
effects (1) resulting from insufficient or inadequate instructions for use, deployment, installation, or operation, or 
any malfunction of the investigational medical device; or (2) resulting from user error or from intentional misuse 
of the investigational medical device. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol # Q170886 
“Cognoa ASD Diagnosis Aid Validation Study” 
 
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Figure 1. Flowchart for classification of adverse device events  
 
 
 
                                                 
                                          
 
 
 
 
 
 
 
 
 
 
Adverse Event Occurrence                     
(i.e., Untoward Medical Occurrence)  
 
Is it device or 
procedure 
related? 
Adverse Event (AE) or Serious 
Adverse Event (SAE) depending on 
criteria 
- Report on Visit CRF  
NO 
YES 
NO 
Does it meet 
seriousness 
criteria? 
Adverse Device Event (ADE) 
- Report on Visit CRF  
 
 
 
YES 
 
Anticipated Serious Adverse Device Effect (ASADE) 
- Reported on Cognoa SADE Form 
- Report on ADE CRF 
 
Serious Adverse Device 
Effect (SADE) 
Unanticipated Serious Adverse Device Effect 
(USADE/UADE) 
- Reported on Cognoa SADE Form 
- Reported on ADE CRF 
- Examples: seizure, event leading to death 
 
YES 
 NO 
Is it anticipated? 
YES 
 
 

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9.2 
Recording AEs/ADEs and SAEs/SADEs 
All AEs/SAEs or ADEs/SADEs will be: (1) evaluated and must be recorded in the subject’s study case report forms 
(CRFs); (2) monitored and tracked from the time of the first treatment.  
At each contact with the subject, the investigator must seek information on AEs/ADEs/SADEs by specific 
questioning and, as appropriate, by examination. AEs/ADEs/SADEs may be observed by the investigator and/or 
clinical research staff, elicited from the subject and/or family member or volunteered by the subject. All observed 
and volunteered adverse signs and symptoms, anticipated or unanticipated, regardless of severity or frequency, 
will be recorded in the case histories (medical chart and CRFs). Included in the description should be the nature of 
the sign or symptom, the date of onset, date of resolution (duration), the severity, anticipated or unanticipated, 
the relationship to study treatment or other therapy, the action taken (if any), and the outcome.   
All SAEs/SADEs, anticipated or unanticipated, must be reported to Cognoa immediately but not later than 5 
working days.  The SADE must be recorded in: (1) the CRF and (2) a written report must be submitted to Cognoa 
within five (5) working days after the investigator first learns of the event and is to include a full description of the 
event and sequelae, in the format detailed by the Cognoa Serious Adverse Event Form. 
 
9.3 
Follow-up of Subjects after AEs 
All reported AEs/ADEs/SAEs/SADEs should be followed until resolution or until the subject’s participation in the 
study ends.  Resolutions of AEs/ADEs/SAEs/SADEs are to be documented on the appropriate CRFs.  All ADEs that 
result in permanent discontinuation from this clinical trial, whether serious or not, should also be reported on the 
subject Non-Completion of Study Form. 
 
10 
POTENTIAL RISKS / BENEFITS 
10.1 
Potential Risks 
Risks related to the study are expected to be minimal.  
 
There are no physical risks of participating in the study. However, one risk could be psychological. Caregivers may 
feel some discomfort in answering questions about their child’s behavior. Children might also feel some 
discomfort being filmed for the video analysis.  
 
Another potential risk is the possible release of sensitive medical, behavioral, or educational information. To 
mitigate the risk of releasing sensitive personal information, we adhere to confidentiality protocols to protect the 
privacy of personal information. When data is published, it is always anonymous and in a manner so that specific 
families or subjects cannot be identified.  
 
10.2 
Potential Benefits 
The subjects may or may not benefit from the study. 
Potential benefit is to identify subjects with ASD, thus enabling earlier therapy, which is known to positively 
impact long-term outcomes. All subjects in the study will receive an appointment with a specialist clinician, which 
is likely to occur in an expedited manner relative to their referral path were they not participating in the clinical 
study.  

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11 
DATA ANALYSIS PLAN 
11.1 
Sample Size 
This is a multi-site, prospective, blinded, active comparator study with up to 725 subjects who have been deemed 
appropriate for evaluation of the device.   
11.2 
Analysis Sets 
The analysis set will include all enrolled subjects who complete assessment. 
11.3 
Statistical Analyses 
Statistical analyses will be conducted per Statistical Analysis Plan version 1.4.6. 
11.4 
Safety Analyses 
Device-related and procedure-related adverse effects (AEs) will be tabulated and analyzed.  
12 
STUDY MANAGEMENT AND ADMINISTRATIVE CONSIDERATIONS  
12.1 
Investigator Selection 
The Investigator(s) will be invited to participate in the study based on his or her medical specialty and experience 
conducting clinical research studies. Access to potential study subjects and the Investigator’s sincere interest in 
this study along with expressed willingness to cooperate with the study process and requirements are also 
considered. 
12.2 
Training and Monitoring 
The investigators and site research staff will be trained on the study procedures. 
 
Investigator will allow sponsor representatives to periodically review the study documentation.  Monitoring of the 
site will occur to evaluate the progress of the study, verify the accuracy and completeness of CRFs, assure that all 
protocol requirements, applicable FDA regulations and the investigator’s obligations are being fulfilled and resolve 
any inconsistencies in the study records. 
12.3 
Informed Consent 
The investigator is responsible for ensuring that informed consent, using an Institutional Review Board (IRB) 
approved informed consent document, is obtained for each subject before the performance of any protocol 
procedures, including administration of the study device. The informed consent document must comply with all 
essential elements as defined in 21 CFR 50.25 “Elements of Informed Consent” and must contain a statement that 
consent is freely given, the study involves research, the subject is aware of the risks and benefits of entering the 
study, and that the subject is free to withdraw from the study at any time.  An evaluation of each candidate will be 
conducted by the investigator. Upon determining a subject’s eligibility status, the subject will be offered the 
opportunity to participate in the study.  
 
The investigator or the investigator’s designee will inform all subjects regarding the purpose of the study and 
expected duration, as well as the potential risks and benefits that may result from participation. The subjects shall 
be informed by the investigator or investigator’s designee that they are free to refuse participation in this clinical 
study. If they elect to participate, it will be made clear that they may withdraw from the study at any time without 
prejudicing further care.  

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The acquisition of informed consent will be documented in the subject’s medical records, as required by 21 CFR 
812.140.  
12.4 
Protocol Compliance 
The principal investigator must comply with all terms of the protocol. 
12.5 
Protocol Amendments 
Neither the principal investigator nor the sponsor will modify or alter this protocol without first obtaining the 
concurrence of the other party (with the exception of amendments which involves mitigating a medical 
emergency or immediate health risk to the subject). The party initiating an amendment must confirm it clearly in 
writing and it must be signed and dated by the sponsor and the principal investigator. IRB approval must be 
obtained before implementation of an amendment. 
12.6 
Protocol Deviation 
Significant protocol deviations must be reported to the IRB according to their policies. 
12.7 
Study Discontinuation 
Cognoa, Inc. (the sponsor) has the right to terminate this study at any time.  Reasons for terminating the study 
may include, but are not limited to, the following: incidence or severity of adverse events in this or other studies 
indicates a potential health hazard to subjects; subject enrollment is unsatisfactory; number of protocol deviations 
is unacceptable; data recording is inaccurate or incomplete; or questionable study site compliance with ICH-E6, 
Good Clinical Practice.  
12.8 
Data Collection, Record Keeping and Storage 
The principal investigator is responsible for assuring that all study records including case report forms (CRFs), 
informed consent forms, device accountability records, source documents (e.g., notes, medical records etc.) and 
other study records are complete, accurate and recorded in a timely manner. All study data will be captured on 
the CRFs.  All data entries on the CRFs will be recorded completely, promptly, and legibly using blue or black 
indelible ink pen and accuracy will be ensured. The corrections on CRFs will be made only by the designated study 
staff. To make a correction to an entry, the data will be crossed through with a single line (the original entry 
should be visible) and then will be initialed and dated by the person making the correction.  
 
The study records will be maintained in a secure location throughout the duration of the study.  Upon study 
completion or termination, records will be kept at a secure location until at least 2 years after the last approval of 
a marketing application and until there are no pending or contemplated marketing applications or at least 2 years 
have elapsed since the formal discontinuation of clinical development of the investigational product.  
12.9 
Subject Confidentiality 
This study preserves the confidentiality of all subjects under the Health Insurance Portability and Accountability 
Act of 1996 (HIPAA) Privacy Rule. The following safeguards will be in place to protect the privacy of the individuals 
who are the subjects of the health information to be used in the research and the confidentiality of that 
information:   
 
The subjects will be informed by the investigator or the investigator’s designee that their medical records will be 
kept as confidential as possible but may be subject to review by: (1) Cognoa, or its representative; (2) reviewing 

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IRB; and/or (3) by appropriate regulatory bodies (e.g. the US Food and Drug Administration (FDA), Department of 
Health and Human Services (DHHS) agencies).  
 
Only pieces of personal information required for purposes of the study will be collected. The personal information 
will be collected and used to ensure subject eligibility for study participation, to conduct the study and to assess 
the results of the study as required and permitted by law. Subjects have the right to see and copy any of the 
information gathered about them and request changes if the information is not correct, until it is no longer kept 
by the investigator. Permission to use or disclose personal information, except for that has been collected and 
relied on may be cancelled by the subject by written notice. If the subject is withdrawn from the study, the 
information collected to that time may still be used to preserve the scientific integrity of the study. There is no 
expiration date to this authorization.  
 
Subjects’ identities will be kept confidential. Subjects will be assigned a unique study code that will not reveal the 
subjects’ identity, and this code will be used on all study documents.  
12.10 Financial Considerations  
 
Subject Compensation: 
The subject’s caregiver will be compensated for their participation, which is defined as completion of caregiver 
assessment, brief videos, and specialist clinician evaluation. 
 
Costs to the Subject: 
The specialist clinician evaluation is part of standard of care referral and should be covered by insurance. The 
costs not covered by subject’s insurance will be covered by the sponsor, up to $1,000.00. Please note that genetic 
testing and/or neuroimaging will not be covered by the sponsor.  
 
Clinician Compensation: 
Referring primary care physicians will be compensated per HCP assessment they complete. 
Specialist clinicians, who handle the primary diagnosis, will be compensated per patient visit. 
Reviewing specialist clinicians will be compensated per independent review of cases. 
 
 

Cognoa, Inc. 
Protocol # Q170886 
“Cognoa ASD Diagnosis Aid Validation Study” 
 
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REFERENCES 
Abbas H., Garberson F., Glover E., Wall D. (2018). Machine learning approach for early detection of autism by 
combining questionnaire and home video screening. Journal of the American Medical Informatics Association, 
Volume 25, Issue 8, August 2018, Pages 1000– 
1007, https://doi.org/10.1093/jamia/ocy039 
 
 
Antezana, L., Scarpa, A., Valdespino, A., Albright, J., & Richey, J. A. (2017). Rural Trends in Diagnosis and Services 
for Autism Spectrum Disorder. Frontiers in psychology, 8, 590. doi:10.3389/fpsyg.2017 
 
Baio J, Wiggins L, Christensen DL, et al. (2018). Prevalence of Autism Spectrum Disorder Among Children Aged 8 
Years - Autism and Developmental Disabilities Monitoring Network, 11
Sites, United States, 2014. MMWR Surveill Summ. 2018 Apr 27;67(6):1-23. doi: 10.15585/mmwr.ss6706a1. 
 
Begeer, S., Bouk, S. El, Boussaid, W., Terwogt, M. M., & Koot, H. M. (2009). Underdiagnosis and referral bias of 
autism in ethnic minorities. Journal of Autism and Developmental Disorders, 39(1), 142–148. 
http://doi.org/10.1007/s10803-008-0611-5 
 
Carbone, P., Norlin, C., & Young, P. (2016). Improving early identification and ongoing care of children with Autism 
Spectrum Disorder. Pediatrics, 137(6) DOI: 10.1542/peds.2015-1850 
 
CDC. (2014). Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years — Autism and Developmental 
Disabilities Monitoring Network, 11 Sites, United States, 2010. Retrieved from 
http://www.cdc.gov/mmwr/pdf/ss/ss6302.pdf 
 
Cidav Z., PhD, Munson J., PhD, Estes A., PhD, Dawson G., PhD, Rogers S., PhD, & Mandell D., ScD. (2017). Cost 
Offset Associated With Early Start Denver Model for Children With Autism. Journal of the American Academy of 
Child & Adolescent Psychiatry,56(9), 777-783. doi: 10.1016/j.jaac.2017.06.007 
 
Dawson G., Rogers S., Munson J., Smith M., Winter J., Greenson J., Donaldson A., & Varley, J., Randomized, 
Controlled Trial of an Intervention for Toddlers With Autism: The Early Start Denver Model, Pediatrics, 
2010;125;e17; originally published online November 30, 2009; DOI: 10.1542/peds.2009-0958 
 
Duda, M., Kosmicki, J. a, & Wall, D. P. (2014). Testing the accuracy of an observation-based classifier for rapid 
detection of autism risk. Translational Psychiatry, 4(8), e424. http://doi.org/10.1038/tp.2014.65 
 
Kosmicki, J. a, Sochat, V., Duda, M., & Wall, D. P. (2015). Searching for a minimal set of behaviors for autism 
detection through feature selection-based machine learning. Translational Psychiatry, 5(2), e514. 
http://doi.org/10.1038/tp.2015.
 
Lord, C., Risi, S., Lambrecht, L., Cook, E. H., Leventhal, B. L., DiLavore, P. C., … Rutter, M. (2000). Autism Diagnostic 
Observation Schedule (ADOS). Journal of Autism and Developmental Disorders (Vol. 30). 
http://doi.org/10.1007/BF02211841. 
 
Lord, C., Rutter, M., & Couteur, A. L. (1994). Autism diagnostic interview-revised: A revised version of a diagnostic 
interview for caregivers of individuals with possible pervasive developmental disorders. Journal of Autism and 
Developmental Disorders, 24(5), 659–685. http://doi.org/10.1007/BF02172145 

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Shattuck PT, Durkin M, Maenner M, Newschaffer C, Mandell DS, Wiggins L et al. Timing of identification among 
children with an autism spectrum disorder: findings from a population- based surveillance study. J Am Acad Child 
Adolesc Psychiatry 2009; 48: 474–483 
 
Snow, A. V, & Lecavalier, L. (2008). Sensitivity and specificity of the Modified Checklist for Autism in Toddlers and 
the Social Communication Questionnaire in preschoolers suspected of having pervasive developmental disorders. 
Autism : The International Journal of Research and Practice, 12(6), 627–644. 
http://doi.org/10.1177/1362361308097116 
 
Wall, D. P., Dally, R., Luyster, R., Jung, J. Y., & DeLuca, T. F. (2012). Use of artificial intelligence to shorten the 
behavioral diagnosis of autism. PLoS ONE, 7(8). http://doi.org/10.1371/journal.pone.0043855 
 
Warren, Z., McPheeters, M. L., Sathe, N., Foss-Feig, J. H., Glasser, A., & Veenstra- Vanderweele, J. (2011). A 
systematic review of early intensive intervention for autism spectrum disorders. Pediatrics, 127(5), e1303–e1311. 
http://doi.org/10.1542/peds.2011-0426 
 
Witwer, A. N., & Lecavalier, L. (2007). Autism screening tools: an evaluation of the Social Communication 
Questionnaire and the Developmental Behaviour Checklist-Autism Screening Algorithm. Journal of Intellectual & 
Developmental Disability, 32(3), 179–187. http://doi.org/10.1080/13668250701604776 
 
Zuckerman, K. E., Lindly, O. J., & Sinche, B. K. (2015). Parental Concerns, Provider Response, and Timeliness of 
Autism Spectrum Disorder Diagnosis. The Journal of Pediatrics, 1–10. http://doi.org/10.1016/j.jpeds.2015.03.007 
 
 
 

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APPENDIX - STANDARDIZED MEDICAL HISTORY AND PHYSICAL FORM 
 
 
HISTORY AND PHYSICAL INTAKE FORM                           
 
  
  
Subject ID 
Date of Evaluation 
 
Biological Sex 
☐Female    ☐Male 
Child’s Name (Last, First) 
Date of Birth 
 
Age (months) 
   
HISTORY OF PRESENTING ILLNESS: 
 
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
 
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
 
______________________________________________________________________________________________________ 
 
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
  
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Age caregiver first became concerned about patient’s development or behavior? __________________________________ 
  
Does the child have any of the following compared to other children his/her age (Circle all that apply): 
 
 Impulsive/Overactive 
 Destructive 
 Unable to separate from parent 
 Short attention span/Distractible 
 Aggressive 
 Sad or Depressed 
 Daydreams 
 Wetting pants/bed 
 Suicidal thoughts 
 Classroom disruption 
 Bowel accidents 
 Eats or Mouths non-food items 
 Is easily overstimulated in play 
 Poor eye-contact 
 Psychiatric/emotional problems 
 Easily frustrated 
 Low self-esteem 
 Plays with toys abnormally 
 Doesn’t follow directions 
 Isolated/withdrawn 
 Sexualized behavior 
 Oppositional/Defiant 
 Excessive worry/fears 
 Obsessions or compulsions 
 Sensitive to noises/ lights/ textures 
 Need for sameness 
 Difficulty making or keeping friends 
 Self-injurious (head bangs, bites/hits self) 
Requires a lot of parental 
attention 
Overreacts when faced with a 
problem 
 Rocking/spinning/hand flapping 
More interested in things than in  
people 
Does not show much emotion 
  
  
Other problems or comments regarding infancy or early childhood development? 
  
___________________________________________________________________________________________________ 
  
___________________________________________________________________________________________________ 
  
___________________________________________________________________________________________________ 
  
___________________________________________________________________________________________________ 
 
___________________________________________________________________________________________________ 

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Protocol # Q170886 
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BIRTH HISTORY 
  
Is child adopted?    ◻ Yes  ◻ No      
In foster care?  ◻ Yes  ◻ No   
If Yes, from what age? ______ 
Mother’s 
age during 
pregnancy 
  
Father’s age 
during 
pregnancy 
Prenatal care received? 
◻ Yes    
◻ No    
Previous pregnancies? ◻ No 
◻ Yes:  If yes, number of pregnancies ____ 
  
Number of miscarriages (if any): _____ 
Prescription medications used during pregnancy:  
  
Maternal use any of the following while pregnant: 
  
◻  Tobacco     ◻  Alcohol     
◻ Marijuana     
◻  Methamphetamines  ◻ Cocaine/Crack  ◻  Heroin     ◻  
Methadone 
  
◻  Other (specify): ________ 
Were there any problems during pregnancy or delivery?   ◻ No    
◻ Yes  (details): 
  
  
  
Full term (40 wks)? ◻ Yes  ◻ No    
 
Birth weight:         
_______ (lbs) 
Or 
_______(kg) 
Birth Length:          
__________ (in) 
Or 
_________ (cm) 
Birth Head Circ:           
 
__________ (in) 
Or 
_________ (cm) 
  If premature, how early?  ___________weeks 
  
If overdue, how late? ______________weeks 
Method of Delivery: 
◻ Vaginal 
◻ C-section     
Did child need any special care after delivery?  ◻ No    
◻ Yes  (details): 
  
  
Health problems (feeding difficulties, poor weight gain, etc.) during infancy?  
◻ No  ◻ Yes (details): 
  
  
Maternal or Paternal Depression following the birth? 
◻ No  ◻ Yes (details): 
  

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Additional Birth History: 
 
DEVELOPMENTAL HISTORY: 
  
Age of first developmental concern:             months 
Please note the age at which your child first did each of the following (write N/A if he/she does not do this yet): 
Sat independently: _______                          
          
Walked 10 steps: _______ 
Said first word (other than mama/dada): _______       
Put two words together (e.g. “my ball”)_______ 
Toilet trained: Bladder ________               Bowel ________   Fed self with utensils (fork, spoon) _______ 
 
Provide an example of something your child might say: 
  
  
Provide an example of how your child lets caregiver know what he/she needs? 
  
  
Caregiver concern regarding child’s ability to think or that learning is delayed? 
◻ No      ◻ Yes, Please specify:  
  
  
How old does caregiver think child seems to act? _________ 
History of child gross motor delays (e.g. sitting, walking, skipping, riding a bicycle, etc.)? 
  
◻ No      ◻ Yes, Please specify:  
  
History of child fine motor delays (e.g. drawing, writing, cutting, eating with utensils)? What any part of child’s small 
muscle development slow? 
  
◻ No      ◻ Yes, Please specify: 
  
Are child’s self-help skills (i.e. dressing, toileting, bathing, etc.) age-appropriate?  
  
◻ Yes ◻ No: Please explain: 
  

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Has child ever lost any previously acquired and well-established language, motor, self-help, or social skills? 
  
◻ No      ◻ Yes -  What age? ____ years.  Please describe: 
  
Any prior developmental evaluations through Early Intervention, Developmental Pediatrics, etc.:  
 
PAST MEDICAL HISTORY: 
 
Circle Any That Apply 
 
Chickenpox      Frequent ear infections     Problems with ears or hearing     Nasal allergies     Problems with eyes or vision      
 
Asthma, bronchitis, bronchiolitis, or pneumonia     Any heart problem or heart murmur     Anemia or bleeding problem 
 
Blood transfusion     HIV     Organ transplant     Malignancy/bone marrow transplant     Chemotherapy 
 
Frequent abdominal pain     Constipation requiring doctor visits     Recurrent urinary tract infections and problems 
 
Congenital cataracts/retinoblastoma     Metabolic/Genetic disorders     Cancer     Kidney disease or urologic malformations      
 
Sleep problems; snoring     Chronic or recurrent skin problems (eg, acne, eczema)     Frequent headaches 
 
Convulsions or seizures     Obesity     Diabetes     Thyroid or other endocrine problems     High blood pressure 
 
History of serious injuries/fractures/concussions      Dental decay 
  
Hospitalizations/ Major Illnesses /Surgeries: 
  
  
  
  
  
 
                                                                                    
 
 
 
SOCIAL HISTORY 
  

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Early Intervention Services:  ◻  No Services  
◻  Current Services (Please specify in hr/week or hr/ month):  
  
Does the child currently attend daycare?  ◻ No     ◻ Yes (Please explain):  
  
 
Current Grade in School (if applicable): 
Type of Class (mainstream or special education services): 
  
  
Concerns (if any) child’s current teacher has? 
  
  
Any evaluations child has received through school district (SST, Speech Evaluation, Psychoeducational evaluation, etc.): 
  
  
Has child ever had an Individual Education Plan (IEP or IFSP)?  ◻ No  ◻ Yes. If yes, reason:  
  
  
Services child CURRENTLY RECEIVES at school and how often (i.e., Resource support or specialized instruction, aide, speech 
therapy, occupational therapy, adaptive PE, social skills group, positive behavioral support plan, etc.). 
  
  
  
  
 
  
Any other services child has RECEIVED IN THE PAST through school. 
  
  
  
   
Please describe any major family stressors at the present time, if any? 
  
  
Please note if there is a history of any of the following (check all that apply): 

Cognoa, Inc. 
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❒ Marital discord/separation/divorce 
❒  Parent deployed overseas/out of 
town for work extensively 
❒ Financial problems 
❒ Custody disputes 
❒  Parent legal problems 
❒ Parent job loss 
❒ Birth/Adoption of another child 
❒  Parent alcohol/ drug use 
❒ Witness physical violence 
❒ Severe sibling/ illness or death 
❒ Living away from parent 
❒ Witness sexual abuse 
❒ Parent emotionally/mentally ill 
❒ Other significant trauma/negative 
event 
  
  
If yes to any of the above, provide circumstances: 
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
  
______________________________________________________________________________________________________ 
 
 

Cognoa, Inc. 
Protocol # Q170886 
“Cognoa ASD Diagnosis Aid Validation Study” 
 
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REVIEW OF SYMPTOMS 
  
Concern 
Never 
Currently 
In the past 
Fatigue 
  
  
  
Sleep problems (falling asleep, staying asleep, snoring, 
difficulty breathing at night, etc.) 
  
  
  
Genetic disorder 
  
  
  
Head injury/brain problem (hydrocephalus, brain bleed) 
  
  
  
Seizures  
  
  
  
Headaches 
  
  
  
Tics, tremors, or unusual movements 
  
  
  
Eye or vision problem 
  
  
  
Ear or hearing problem 
  
  
  
Dental or tooth problem 
  
  
  
Nose and Throat problems 
  
  
  
Heart problem 
  
  
  
Heart rhythm problems 
  
  
  

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Protocol # Q170886 
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Concern 
Never 
Currently 
In the past 
Breathing/lung problem, asthma 
  
  
  
GI problem: vomiting/reflux/stomach pain 
  
  
  
Diarrhea (loose, watery stools) 
  
  
  
Constipation (hard, painful stools) 
  
  
  
Feeding problem or use of a feeding tube 
  
  
  
Limited diet (picky eater): 
  
  
  
Kidney/bladder/genital problems 
  
  
  
Bone, joint, or muscle problems 
  
  
  
Anemia or other blood problems 
  
  
  
Skin conditions or birthmarks 
  
  
  
Endocrine or hormone problems 
  
  
  
Growth problems (short stature, overweight/underweight, 
etc.) 
  
  
  
Allergies 
  
  
  
Health concern not listed above 
  
  
  

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Child uses any adaptive equipment (circle)? 
  
 Glasses         Hearing aids    
  Walker     
Wheelchair    
 Communication device 
  
  Other: 
  
  
  

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BIOLOGICAL FAMILY HISTORY 
Please note who, if any, of the child’s biological relatives have had these conditions (“blood related” family members only;        
i.e. biological parents, siblings, aunts, uncles, grandparents) 
  
 Conditions: 
Relative(s) with the condition 
(if 2d degree relation, specify maternal or paternal) 
 Autism Spectrum Disorder 
  
 ADHD 
  
 Learning disabilities or intellectual disability 
  
 School failure (please explain) 
  
 Developmental delays (speech delay, delayed walking, etc.) 
  
 Schizophrenia or psychosis 
  
 Depression 
  
 Bipolar Disorder 
  
 Anxiety or OCD 
  
 Tics or Tourette’s Disorder 
  
 Seizures 
  
Genetic disorder (Down Syndrome, Fragile X Syndrome, 
Tuberous Sclerosis Complex,, Neurofibromatosis, etc.) 
  
 Substance abuse (alcohol, drugs, etc.) 
  
 Other/Additional Details (Please Specify) 
  
  
  
  

Cognoa, Inc. 
Protocol # Q170886 
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Current medication(s) that child takes: 
  
  
  
  
   
  
  
  
ALLERGIES: 
❒ Not Known Medication Allergies 
  
  
IMAGING, LABORATORY, AND NEUROPSYCHOLOGICAL TESTING 
(attach reports if available, excluding/redacting assessment portion) 
Test 
Yes 
Don’t Know 
If Yes, Abnormal? 
Array CGH (microarray) or Karyotype 
 
 
Details: 
Fragile X 
 
 
Details: 
Testing for Rett Syndrome (MECP2) 
 
 
Details: 
Whole Genome/ Exome 
 
 
Details: 
MRI of the brain 
 
 
Details: 
EEG (electroencephalogram) 
 
 
Details: 
Sleep Study 
 
 
Details: 
Audiology (Hearing) Testing 
 
 
Details: 

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Protocol # Q170886 
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Neuropsychological Testing 
 
 
Details: 
Other: 
 
 
Details: 
  
PHYSICAL EXAMINATION 
  
Height: ________________cm    
Weight: _______________kg    
Head Circumference: _______________cm 
(attach growth charts if available) 
  
CATEGORY 
STATUS 
IF ABNORMAL, DESCRIBE BELOW 
Vital Signs 
☐Normal 
☐Abnormal 
☐Not Examined 
  
General Appearance 
☐Normal 
☐Abnormal 
☐Not Examined 
  
HEENT 
☐Normal 
☐Abnormal 
☐Not Examined 
  
Respiratory 
☐Normal 
☐Abnormal 
☐Not Examined 
  
Cardiovascular 
☐Normal 
☐Abnormal 
☐Not Examined 
 
  

Cognoa, Inc. 
Protocol # Q170886 
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CATEGORY 
STATUS 
IF ABNORMAL, DESCRIBE BELOW 
Abdomen 
☐Normal 
☐Abnormal 
☐Not Examined 
  
Genitourinary 
☐Normal 
☐Abnormal 
☐Not Examined 
  
Musculoskeletal 
☐Normal 
☐Abnormal 
☐Not Examined 
  
Lymph Nodes 
☐Normal 
☐Abnormal 
☐Not Examined 
  
  
Skin 
☐Normal 
☐Abnormal 
☐Not Examined 
  

Cognoa, Inc. 
Protocol # Q170886 
“Cognoa ASD Diagnosis Aid Validation Study” 
 
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Neuropsychiatric: 
- Mental Status 
☐Normal 
☐Abnormal 
☐Not Examined 
Appearance/Behavior (e.g. level of motor activity, eye contact): 
  
  
  
Apparent reaction to situation/reactivity level to sensory stimuli: 
  
  
  
  
Speech/Language: 
  
Vocalization/speech production 
  
  
  
Affect (range of expressed emotions) 
  
  
  
Thought Processes: 
  
  
  
Thought Content: 
  
  
  
Cognition: 
  
  
  
Neurological: 
- Cranial Nerves 
☐Normal 
☐Abnormal 
☐Not Examined 
  
Neurological: 
- Tone, Motor & 
Coordination 
☐Normal 
☐Abnormal 
☐Not Examined 
Check if any abnormal movements noted: 
☐ Tics       ☐ Chorea     ☐ Stereotypy 
  

Cognoa, Inc. 
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Neurological: 
- Reflexes 
☐Normal 
☐Abnormal 
☐Not Examined 
  
Neurological: 
- Sensory 
☐Normal 
☐Abnormal 
☐Not Examined