Cognoa ASD Digital Therapeutic Engagement and Usability Study
Phase: NA
Conditions: Autism Spectrum Disorder
Sponsor: Cognoa, Inc.

Cognoa, Inc. 
Protocol # PRO-003 
“Cognoa ASD digital therapeutic engagement and usability study”  
 
 
  
 
 
Protocol Number: 
PRO-003 
Protocol Title: 
Cognoa ASD digital therapeutic 
engagement and usability study 
Sponsor: 
Cognoa, Inc. 2185 Park Blvd. 
Palo Alto, CA 94306  
Telephone: 408-207-6659  
Contact: Kelley Abrams, PhD 
Email:kelley.abrams@cognoa.com 
Version, Date: 
Version 3.0 May 3, 2020 
 
 
 
 
 
Statement of Compliance 
The study will be conducted in accordance with the design and specific provisions of this IRB approved 
protocol, in accordance with the ethical principles that have their origin in the Declaration of Helsinki, 
and that are consistent with Good Clinical Practice (GCP) and the applicable regulatory requirement(s). 
 
 
 
 
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 
 
PROTOCOL #: PRO-003 
 
Study Title: Cognoa ASD Digital Therapeutic Engagement and Usability Study 
 
 
Protocol Version Version 3.0 May 3, 2020 
 
I have received and read the protocol dated May 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 
 
 

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Table of Contents 
 
Statement of Compliance 
1 
Protocol Signature Page – Principal Investigator 
2 
Table of Contents 
3 
Protocol Summary 
4 
Overview of Autism Spectrum Disorder 
5 
Standard of Care – Treatment of Autism Spectrum Disorder & Barriers 
5 
1 Study Device Description 
8 
2 Study Objectives 
9 
2.1 Study Purpose 
9 
3 Study Outcome Measures 
9 
4 Study Duration 
9 
5 Study Population 
10 
5.1 Study participant Recruitment and Selection 
10 
5.2 Inclusion Criteria: 
10 
5.3 Exclusion Criteria: 
10 
6 Study Assessment 
10 
6.1 Training 
11 
6.2 Usability Metrics 
11 
7 Data Collection and Storage 
12 
8 Adverse Events 
12 
8.2 Recording AEs/ADEs and SAEs/SADEs 
13 
8.3 Follow-up of participants after AEs 
14 
9 Potential Risks/Benefits 
14 
10 Study Management and Administrative Considerations 
15 
10.1 Informed Consent 
15 
10.2 Participant Confidentiality 
15 
10.3 Financial Considerations 
16 
10.4 Study Discontinuation 
16 
References 
16 
 

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Protocol Summary 
Title 
Cognoa ASD digital therapeutic engagement 
and usability study 
Objective 
To assess the usability and efficacy of the 
device. 
Study Design 
Single-arm prospective interventional study 
Enrollment 
Up to 30 participants 
Outcome 
Measures 
Change in scores on the Vineland-3 domain 
level caregiver report social skills and 
relationships 
 
Measures of Usability 
Subject 
Population 
Caregivers and female and male participants 
between the ages > 3 years and < 9 years of 
age on date of enrollment from a general 
population diagnosed with ASD  
Planned Schedule 
Enrollment, baseline assessment, 4 weeks of 
intervention 4-6 times a week, weekly surveys 
of usability, final assessment. 
 
 

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Overview of Autism Spectrum Disorder 
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder that affects 
socialization, 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 (HCPs) 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 lack of joint attention, poor eye contact, difficulty reading social cues and facial 
expressions, 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. Most 
studies related to comorbidities in ASD have shown increased rates of anxiety and 
attentional disorders, when left untreated, reflecting cognitive, language, and social 
problems (Leyfer, Folstein, Bacalman, et al., 2006). 
 
 
 
 
 
Caregivers are also greatly impacted with higher rates of stress, depression, anxiety, 
and other mental health disorders than in parents of children with other developmental 
delays and disabilities (Dumas, Wolf, et al., 1991; Hayes & Watson, 2013). 
Standard of Care – Treatment of Autism Spectrum Disorder & Barriers 
 
 
 
 
 
Reciprocal social behavior, a foundational capacity to engage in contingent social 
interactions important for learning and relationships, is typically disrupted in autism 
spectrum disorder (ASD). If unaddressed, the social deficits experienced by individuals 
with ASD can lead to lifelong struggles and a disabling condition. The National Institute 
of Mental Health (NIMH Report to Congress) and Interagency Autism Coordinating 
Committee (IACC Portfolio Analysis Report) identified the development of interventions 
to address social impairment in individuals with autism as a high priority. Individuals 
with ASD typically have few friends and experience loneliness due to difficulties 
recognizing subtle social cues and emotional states in others (Bauminger et al., 1999). 
ASD individuals who have social communication difficulties have significant challenges 
with the ability to form and maintain relationships. Without appropriate effective 

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intervention, therefore, ASD can result in loneliness, isolation, and an increased risk of 
depression and suicide (Hedley and Uljarevic, 2018). As such, developing friendships is 
recognized as one of the top goals of children, adolescents, and adults with ASD 
(Orsmond et al., 2004). 
 
 
 
 
 
 
There is no cure for Autism. Interventions consist in treating symptoms, to reduce their 
severity and improve behavioral, social, emotional, and cognitive functioning. They 
include intensive behavioral interventions, rehabilitative services such as speech 
therapy, occupational therapy, physical therapy, social skills training, and counseling. 
Traditional pharmacotherapy may also be used to treat symptoms in ASD patients (e.g 
irritability, aggression) but does not affect the core symptoms of ASD (Choueiri & 
Zimmerman, 2017). 
 
 
 
 
 
 
Among all children with an ASD diagnosis, 64% had received behavioral therapy in the 
past 12 months while 27% used medication to ease the symptoms (Zuckerman et al, 
2017). No current medical intervention demonstrates clear benefit for social or 
communication symptoms in ASDs other than behavioral therapy approaches 
(however, 2 recent studies have concluded that standard behavioral therapy assessed 
in RCTs do not show effect). Furthermore, there are no currently FDA approved 
pharmacotherapies indicated for use to treat the core symptoms of ASD directly. 
Psychotropics are sometimes prescribed for irritability, such as risperidone and 
aripiprazole, especially in children who received an ASD diagnosis at older ages (Ji & 
Findling, 2016; Zuckerman, Lindly, & Chavez, 2017). Monitoring guidelines for these 
medications, due to possible side effects, include monitoring weight, height, and body 
mass index, extrapyramidal symptom screening, blood pressure, abdominal girth and 
liver enzymes, fasting plasma glucose, and fasting lipids. Adherence to monitoring for 
all measures in one study was only 20% (Javaheri et al., 2019). Intranasal oxytocin has 
shown some potential for improving some aspects of social functioning such as 
emotion recognition and eye gaze (Preti et al., 2014). Although FDA granted Roche 
Breakthrough Therapy designation in 2018 for its Balovaptan product (selective small 
molecule antagonist of the vasopressin V1A receptor), it remains in Phase III. 
 
 
 
 
 
 
The current standard of care for treating socialization difficulties in children with ASD is 
behavioral therapy, and most prominently a therapy called Applied Behavioral Analysis 
(ABA) (Lovaas, 2003). ABA relies on teaching social skills in clinical sessions, via tools 
such as flashcards involving memorization of facial emotions (Figure 1) (Landa et al., 
2011 and Lerman et al., 2004). Severity of autism is also associated with higher rates of 
behavioral interventions, whereas only one in four children with mild ASD received any 
intervention. 
 
 
 
 
 
 
ABA therapy is delivered both in the home as well as via clinic-based services, 
depending on a myriad of factors such as child age, availability of therapists, cost, 
transportation and logistics concerns, and treatment model of the provider. Parent and 
family participation and engagement outside of treatment hours, however, is 
consistently recognized as positively contributing to successful outcomes in children. 

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Greater parental involvement during treatments that fit into natural everyday routines 
not only increase the effectiveness of interventions but also improves parents’ sense of 
self-efficacy and reduces their levels of stress (Hastings and Symes 2002; Moes 1995; 
Koegel et al. 1996a). 
 
 
 
 
 
 
 
Figure 1. Flashcard examples used in ABA therapy today. 
 
 
 
 
 
 
 
Experts recommend 20 hours per week of Applied Behavioral Analysis with a 
behavioral therapist for at least two years (Mazurek et al., 2014). Although ABA therapy 
can be effective in increasing IQ, improving eye contact, face-to-face gaze, and 
emotion recognition, children who receive ABA often struggle to generalize learned 
behaviors to natural interactions and are dependent on prompts (Lovaas et al., 1987). 
That is to say, they may perform better at emotional recognition and corresponding 
tasks in the same environment with a therapist, but may not perform as well outside of 
the controlled environment.  
 
 
 

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1 Study Device Description 
The study device is an investigational digital therapy that uses Augmented Reality-
based social behavioral therapy, as an adjunct to standard outpatient applied 
behavioral analysis therapy, to improve adaptive behavior, specifically social skills in 
children with Autism Spectrum Disorder.  
 
The Device is a smart device (smartphone)-based therapy aid for children with ASD to 
encourage facial engagement, emotion recognition, and provide real-time feedback 
(via cues) to the child during social interactions at home. The intervention is provided to 
the child via a mobile application that is centered around a Facial Expression 
Recognition Activity (FERA), powered by machine-learning, and an Emotions Guessing 
Game (EGG); these two steps provide the main therapeutic mechanisms of action. The 
application is engaging and provides a regimented therapy administration to improve 
outcomes associated with socialization domains in Autism Spectrum Disorder. 
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The Facial Expression Recognition Activity (FERA): the caregiver moderates the 
session, wherein the child aims the smartphone at the caregiver or other familiar adult 
within their natural and  familiar environments (namely their own home or that  of their 
extended family and friends), and either “finds” or tries to elicit 1 of several  emotions 
that is prompted by audio in-app. Often, in the home setting, the emotion will be 
generated by the caregiver; the instructions to the caregiver will be to replicate the 
requested emotion or, during use of the Device in areas with multiple people, the 

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caregiver will be instructed to  help the child find individuals expressing the  prompted 
emotion; if none exist, the caregiver may choose to replicate the emotion (similar to 
EGG, described below) or prompt another individual in close proximity to replicate the 
emotion without alerting the child. The child points the phone camera towards the 
individual who they believe is expressing the prompted emotion; the mobile app has an 
Augmented Reality (AR) component that alerts the child  when a face is detected. The 
screen then provides the child real-time audio and visual feedback correctly labeling 
the emotional expression displayed on the face. 
The Emotional Guessing Game Activity (EGG): after the FERA activity is completed, the 
caregiver and child enters the EGG component of the application. The EGG stores 
previous images that the child has evaluated  -- for example, the expressive faces 
successfully discovered during the FERA activities --  mixed with stock face images 
(from pre-reviewed sources). The goal of this activity is to reinforce and remind the 
child of their correct choices to improve retention. The child can then try to correctly 
match or label the emotional expressions displayed in the images. The goal from this 
EGG is to provide a bridge between FERA sessions that reinforces the learnings from 
the AR-based FERA in a different, 2D environment. It also provides additional social 
interaction opportunities between caregiver and child to review and discuss the 
emotions together. 
2 Study Objectives 
Cognoa will measure usability, engagement with the device, and changes in parent-
reported socialization during a 4-week period of intervention at home with the Cognoa 
ASD therapeutic device. 
2.1 Study Purpose 
The purpose of this study is to evaluate the safety, effectiveness and usability of the 
device smartphone application, and Quick Start Guide) with intended users.  
3 Study Outcome Measures 
● Usability assessment of Cognoa ASD Therapeutic Device 
● Change in scores on the Vineland-3 domain level caregiver report social skills 
and relationships from baseline to 4 week measurement  
4 Study Duration  
Duration of subject participation is approximately 4 weeks.  
 
Total study duration is approximately 12 weeks. 

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5 Study Population 
5.1 Study participant Recruitment and Selection  
Up to 30 caregivers and children diagnosed with ASD ages  > 3 to < 9 years of age will 
be recruited from across the U.S.  
 
Only subjects who meet all eligibility criteria will be enrolled into the study.  Eligibility 
will be determined during a scheduled phone call by Cognoa recruiters.  
 
5.2 Inclusion Criteria:  
● Functional English language capability in the home environment. 
● Parent, Guardian, or legal authorized representative (LAR) must be able to 
read, understand and sign the Informed Consent Form (ICF) 
● Female or Male, > 3 to < 9 years of age and parent/caregiver 
● Diagnosis of Autism Spectrum Disorder 
● Parent, Guardian, or legal authorized representative (LAR) must have 
smartphone capabilities for downloading Testflight software to access the 
Cognoa for Child development app; and the Cognoa Digital Therapeutic 
app (iOS 12.0 and up and Apple iPhone 8 and higher) 
 
 
5.3 Exclusion Criteria:  
● Participants with any other medical, behavioral, or developmental 
condition that in the opinion of the investigator may confound study 
data/assessments. 
● Participants with planned extensive travel (more than 1 week) during the 
course of the 4-week intervention time period. 
● Participants with deafness or blindness. 
● Participants with known physical impairments affecting their ability to use 
their hands. 
● Participants with active diagnosis of epilepsy and uncontrolled seizures. 
● Participants whose age on the date of enrollment is outside the target 
age range. 
 
 
6 Study Assessment 
 

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Parents who consent will be given access to the study device through its caregiver and 
child-facing smartphone app that provides therapeutic content. In order to access the 
study device app, parents will be provided access to two other apps. The first is 
Testflight. TestFlight is an online service for over-the-air installation and testing of 
mobile applications, currently owned by Apple Inc. that allows users to test iOS apps 
before they are released to the App Store. Parents will also be provided access to the 
Cognoa for Child Development app in order to create an account as a means to gain 
access to the study device app. The parents will only be able to engage with the study 
device app once they have created an account in the Cognoa for Child for 
Development app. 
Parents will be instructed to use the study device with their child at home (not in public 
places) 4-6 times a week for 4 weeks.  Parent report of the child’s socialization will be 
measured at baseline (prior to starting to use the study device) and at the conclusion of 
the 4-week intervention period. Vineland-3 domain level caregiver report social skills 
and relationships will be administered over the phone by a trained research assistant or 
in an app.  Usability metrics will also be collected by survey weekly (e.g. ease of use for 
child, frustration level, fatigue).  Device usage, engagement, and progress metrics from 
the study device app will be collected throughout the study. Parent report of child’s 
socialization will be collected using the Vineland-3 pre and post use of the study 
device. In addition, parents will fill out a Usability survey weekly throughout the study.  
These are the only 2 measures/surveys that parents fill out once enrolled in the study. 
6.1 Training 
The investigator and site research staff will be trained on the protocol and on all study 
procedures. 
 
Monitoring of the site will occur to evaluate the progress of the study, verify the 
accuracy and completeness of data, assure that all protocol requirements, applicable 
FDA regulations and investigator obligations are being fulfilled and resolve any 
inconsistencies in the study records.  
6.2 Usability Metrics  
● Average duration of sessions using the device  
● Total number of sessions completed 
● Ratings of fatigue 
● Ratings of frustration 
● Ratings of irritability 
● Ratings of comprehension of Instructions for caregivers 
● Ratings of comprehension of Instructions for children 
● Ratings of user app burdensome 
● Ratings for the loading screen 
● Ratings for the text to understand 
● Ratings of video showing how to play first time 

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● Ratings of user free play 
 
7 Data Collection and Storage 
Data collection will be completed using electronic and/or paper report forms provided 
by Cognoa and data will be recorded into Cognoa dedicated study data repository. 
Data fields will include: 
● Date of ICF 
● Participant demographics 
● Device usage metrics 
● VABS-3 caregiver report social skills and relationships domain answers 
and scores 
● Usability metrics 
 
The study data will be maintained in a secure location throughout the duration of the 
study. The pictures of the caregivers taken by the study participants will be stored in 
the device app, as well as on an Amazon S3 cloud server with secured access and 
SSL encryption. 
 
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.  
8 Adverse Events   
8.1 Definitions 
An adverse event (AE) is defined as 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. 
 
A serious adverse event (SAE) is any adverse event, whether related to the use of the 
investigational device or not, that: 
● led to a death; 
● led to a serious deterioration in the health of the subject that:  
● resulted in a life-threatening illness or injury; 
● resulted in a permanent impairment of a body structure or body function; 

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● required in-patient hospitalization or prolongation of existing 
hospitalization; 
● 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. 
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.  
 
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. 
 
8.2 Recording AEs/ADEs and SAEs/SADEs  
All reported AEs/SAEs or ADEs/SADEs will be: (1) evaluated and must be recorded in the 
participant’s study case report forms (CRFs); (2) monitored and tracked from the time of the 
first treatment. 
At each contact with the participant, 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 participant and/or family member or volunteered by the participant.  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 descriptions should be the nature of the sign or symptom, the date of 

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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.  
8.3 Follow-up of participants after AEs  
All reported AEs/ADEs/SAEs/SADEs should be followed until resolution or until the 
participant’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 participant Non-
Completion of Study Form.  
 
 
9 Potential Risks/Benefits 
 
9.1 
Potential Risks 
Risks related to the study are expected to be minimal.  
 
Physical risks for participating in the study are expected to be minimal. Children may 
experience some fatigue holding the device during intervention sessions.  Children may 
also experience some irritation and frustration while using the device.  
 
Caregivers/parents may feel some emotional discomfort from being asked or 
answering questions about their child’s behavior. 
 
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.  
 
9.2 
Potential Benefits 
The subjects may or may not benefit from being enrolled in the study. 

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10 Study Management and Administrative Considerations  
10.1 Informed Consent  
The investigator or the investor’s designee will inform all subjects regarding the 
purpose of the study and expected duration, as well as any potential risks and benefits 
that may result from participation.  The subjects shall be informed by the investigator 
or investor’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.  
 
The caregivers of the child will be given access to the informed consent form via email. 
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. 
 
10.2 Participant Confidentiality  
This study preserves the confidentiality of all subjects. 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 records will be kept as confidential as possible but may be subject to review by: 
(1) Cognoa, or its representative; (2) reviewing 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 personal information required for the study will be collected. This will include 
information related to the eligibility for participation (see inclusion/exclusion criteria). 
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 data that have been collected and relied on may be cancelled by the subject 
by written notice. If the subject withdraws 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 
records.  
 

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10.3 Financial Considerations  
Subject Compensation: 
The subject’s caregiver will be compensated up to $200 for their participation.   
$100 for completion of the baseline assessment and $100 at the conclusion of the 
study following the final assessment and completion of the 4 weeks of device use 4-6 
times a week. 
 
 
10.4 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: subject 
enrollment is unsatisfactory; number of protocol deviations is unacceptable; data is 
inaccurate or incomplete; questionable site compliance with Good Clinical Practice; or 
incidences of adverse events in this or other studies indicating a potential health 
hazard to subjects.  
 
References  
American Psychiatric Association. (2013). DSM-V 
(Diagnostic and Statistical Manual of Mental Disorders, 
5th edition). In American Journal of Psychiatry. 
 
Bauminger, N., & Kasari, C. (1999). Brief report: theory of 
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