Reference Database Development for the Quotient® System iPad Test

Conditions:Healthy Studies
Therapuetic Areas:Other
Age Range:6 - 80
Start Date:April 2016
End Date:March 2017
Contact:Cheryl Ritchie, RN, BSN

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Reference Database Development for the Quotient® System iPad Test (Ages 6 - 80 Years Old)

This study is being conducted to create a database for the Quotient® System iPad Test. Using
community sampling, NCS Pearson will compile the results of this study to create a database
against which the results of clinical Quotient tests may be compared to determine patient
performance relative to the expected results for developmental age and gender.

Study Design:

This study is being conducted at 4 clinical sites and consists of up to two study visits.
All study participants will complete at least one study visit. A smaller cohort of
participants will complete a second visit for the purpose of assessing test retest
reliability across the study sample. Subjects will be recruited using the clinic's relevant
patient population and IRB approved recruitment material. Interested volunteers will
participate in an initial screening, which may be done by telephone or in person that will
be conducted by the clinic's research staff. Upon preliminary confirmation that the subject
meets all inclusion criteria and does not meet any exclusion criteria, an appointment will
be scheduled for the first study visit.

At the first visit, the study will be explained in detail. Adults will be asked to provide
written informed consent. Parents or guardians of individuals under the age of 18 years old
will provide written informed consent on behalf of the minor. Individuals between the age of
7 and 18 years of age will also provide their written assent. All consents and assents will
be obtained prior to any study procedure being performed. Following consent, a brief medical
history, including current medications the subject is taking, will be obtained. Subjects
will complete a standard self-assessment questionnaire, appropriate for age, to screen for
presence of ADHD. Subjects will not be excluded from the study based on responses to the
questionnaire but their results will be considered in the analysis of study data. All
subjects will take the appropriate version; Child (ages 6 -12.11), Adolescent (ages 13 -
19.11), or Adult (ages 20 - 79.11) of the 15-minute Quotient® System iPad Test.

At this visit, a cohort of participants across 7 age groups will be asked to return the
clinic for a second study visit. These participants will be asked, in consecutive order of
enrollment, to return to the clinic for a second study visit. Study participants who
complete visit one are not required to participate in the retest cohort group and may opt
out of returning to the clinic for visit two. Once the required number of participants (350
- 400) have completed the second study visit, that portion of the study will be closed to
further enrollment and no further subjects will be given the option to return for the retest
visit (visit 2).

Retest Visit 2 will occur 7 - 14 days following study visit 1. Subjects will be assessed for
changes in health status and current medications since the time of visit 1. Subjects will
repeat the appropriate version (Child, Adolescent or Adult) of the 15-minute Quotient®
System iPad Test.

● Study Enrollment: A minimum of 1440 subjects with oversampling of 11%. Total enrollment is
expected to be approximately 1600.

● Study Population:

Visit 1:

Male and female subjects from the age of 6 years until the age of 80 years. There will be a
total of 16 age bands with approximately 90 subjects enrolled in each age band. Optimally,
there will be a 50-50-male/female-gender stratification per each age category.

Visit 2:

A cohort of at least 350 subjects who have completed study Visit 1 will be asked to return
for Visit 2. An oversampling of 11% is anticipated bringing the total number of subjects
asked to return for Visit 2 to approximately 400. Visit 2 will include both male and female
participants from 7 age bands.

- Study Procedures:

1. Review Inclusion/Exclusion Criteria

2. Obtain Written Adult Informed Consent

3. Obtain Written Minor Informed Assent

4. Verbal Report of Medical History

5. Concomitant Medications

6. Self-assessment Questionnaire:

1. ADHD Self Rating Scale (ADHDRS-IV) for subjects ages 6 - 19.11

2. ADHD Symptom Rating Scale (ASRS-V1.1) for subjects ages 20 - 79.11

7. Quotient® System iPad Test - Child, Adolescent or Adult test as appropriate for

- Study Duration:

Dependent on accrual but estimated to be six (6) months to nine (9) months.

● Statistical Analysis Plan: The data of the study will be used to identify normative ranges
and percentiles by age and gender. Each age range group of 90 will be compared for group
differences between genders, and evaluated for the effects of age on performance. The SPSS
software (SPSS Inc., Chicago, Illinois) will be used for statistic procedures in this study.

Inclusion Criteria:

1. Male or Female

2. Ages 6 years - 79 years and 11 months (79.11) of age

3. Report of good physical health

4. Able to understand test instructions and comply with testing

5. Willing to give written informed consent and/or assent

Exclusion Criteria:

1. History of known neurological disease or insult (e.g., head trauma with LOC, skull
fracture, seizure disorders). History of febrile seizure does not exclude subject
from study participation

2. Major Medical Disorders known to the Investigator that would make it difficult for
the participant to complete study requirements

3. Any major medical or neurological condition that could affect motor activity or
attention (e.g. Parkinson's, MS, dementia)

4. Currently ill with cold, flu or infections which may compromise their ability to
perform the computer task

5. Any condition in which the investigator deems the subject inappropriate for
participation in the study
We found this trial at
Las Vegas, Nevada 89128
Principal Investigator: Ann C Childress, MD
Phone: 702-838-0742
Las Vegas, NV
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Clinton, Utah 84015
Principal Investigator: Samantha Bostrom, MD
Phone: 801-614-5805
Clinton, UT
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Layton, Utah 84041
Principal Investigator: Marc O Anderson, MD
Phone: 801-773-4840
Layton, UT
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Raleigh, North Carolina 27615
Principal Investigator: James M Poole, MD
Phone: 919-488-0015
Raleigh, NC
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