Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE)
Conditions: Mild Cognitive Impairment, Dementia
Sponsor: Ohio State University

Validity of the Electronic Self-Administered Gerocognitive Examination (eSAGE) – 
Smartphone 
 
 
NCT02544074 
 
 
 
1/10/2017 
 
 
 

Protocol 
 
Validity of the Electronic Self-Administered Gerocognitive Examination 
(eSAGE) 
 
Douglas W. Scharre, MD, Haikady Nagaraja, PhD., 
Division of Cognitive Neurology, Department of Neurology, The Ohio State University 
1/10/17 
 
Introduction  
      Cognitive impairment is becoming increasingly prevalent in the US. Approximately 4.7 
million Americans currently have Alzheimer’s disease (AD) with an estimated growth to 13.8 
million by 2050.  An additional 3% to 22% of those over 60 years of age are thought to currently 
meet criteria for Mild Cognitive Impairment (MCI). The early detection of MCI and dementia is 
critical, as studies have shown that early pharmacological intervention may delay the progression 
of AD. Timely identification will become even more important once disease modification 
treatments are available. Unfortunately, most cognitively impaired patients do not seek early 
medical attention and physicians may not recognize subtle cognitive deficits during routine 
office visits. Patients typically present to their doctor 3 to 4 years after symptoms have begun. 
Furthermore, even practitioners aware of cognitive complaints may not perform a cognitive 
assessment, make a diagnosis or initiate medical interventions until at a later, more progressed 
stage of the disease. In fact, more than 40% of patients with mild dementia are not detected and 
diagnosed by their primary care physician. Use of sensitive and easily administered cognitive 
screening instruments is essential in overcoming the many obstacles encountered by physicians 
for early identification of MCI and dementia.  
     Online cognitive screening may provide early detection of cognitive impairment with the 
goals of directing these individuals to their physicians for evaluation and enhancing timely 
identification of pre-dementia research participants. However, online screening for cognition has 
been limited with mixed results.  Although many excellent cognitive screening tests have been 
developed with good sensitivity and specificity for dementia recognition, most require an 
administrator and most are not available online.  
     The Self-Administered Gerocognitive Examination (SAGE) is a valid and reliable cognitive 
assessment tool used to identify both MCI and early dementia. SAGE’s self-administered 
feature, pen and paper format, and four equivalent interchangeable forms allows it to be given in 
almost any setting, does not require any staff time to administer and makes it practical to rapidly 
screen large numbers of individuals in the community or in their home. SAGE consists of several 
parts.  There are demographic questions, subjective questions, and objective cognitive testing.  
       In recent years, as more individuals gain access and become comfortable with the Internet, 
they are also accessing medical information online. Online retrieval of medical information can 
provide critical knowledge to consumers to improve their health. It may help them better 
understand their medical conditions or symptoms and potentially give them insight into ways to 
diagnose and treat their medical conditions. This information can be accessed anywhere they live 
in the world. In addition, there are websites that now offer health screenings including cognitive 
screening. The lay public has great interest and concern about their cognition and worry about 
developing neurodegenerative conditions like Alzheimer’s disease. There are very few screening 
tests that target MCI. Having a validated online cognitive screening test may be very helpful for 

individuals to identify their cognitive issues and have physician evaluation earlier than normally 
occurs. Individuals may also want routinely check their cognitive status annually through these 
online methods if validated. Since SAGE is self-administered, it could be an ideal tool to be used 
in a digital format online. The validity of SAGE in paper format had been studied and published 
(Scharre, 2010). We propose to study the validity of SAGE in a digital format for cognitive 
screening.  
 
Study Objectives 
Our objective is to validate SAGE in digital format (eSAGE) as a practical screening tool for 
detecting MCI and early dementia with a low false positive rate, by performing detailed 
neuropsychological testing on those individuals that did and did not make errors on eSAGE. We 
hypothesize that eSAGE will correlate well with gold standard neuropsychological testing 
designed to differentiate normal cognition from MCI and early dementia. We also hypothesize 
that the paper (SAGE) and electronic (eSAGE) versions of SAGE tested in a given individual 
will not show significantly different scores and will be correlated to each other to the extent that 
they could be used interchangeably.   
 
Methods and Design   
A.  Subject Selection 
      1.  Inclusion Criteria 
           a. Adults over 49 years old of either gender 
           b. Vision and hearing sufficient for compliance with tests 
2.  Exclusion Criteria 
      a. Diagnosis by a physician of moderate or severe dementia  
      b. Intellectual disability  
 
B.  Method 
       Subjects over 49 years of age with sufficient vision and English literacy will be recruited 
from a wide variety of community events including senior centers, health fairs, educational talks 
to lay public, independent and assisted living facilities, and free memory screens as well as from 
ambulatory Geriatric or Memory Disorders Clinics. The SAGE cognitive screening tool will be 
given to all subjects willing to take the test. 
 
Participants who complete the SAGE test and meet inclusion and exclusion criteria will be 
divided into groups based on their initial SAGE scores. Each group will be composed of subjects 
with the same score. Individuals will be randomly selected from each group and asked to further 
participate in a one-time clinical evaluation. We will recruit approximately 5 subjects for each 
SAGE score from 10 to 22 at screening. Voluntary written informed consent and permission 
from the subject to interview a person who knows the subject well will be obtained. This could 
be a family member or a friend.  Questions will be asked about the subject’s cognitive and 
functioning abilities, known medical problems, and about any abnormal behavioral symptoms 
the patient may have.  This interview may be telephonic.  All efforts will be made to interview a 
close subject contact but this will not be exclusionary if no contact can be achieved. 
      The subject will be scheduled for one visit to complete the study.  At that time the patient 
will be administered the outcome measures listed below, a medical history taken, and physical 
and neurological examinations performed including vital signs.  The entire visit will take 
approximately 3 hours. There will be no cost to the patients to be included in this study.  If 

previously unknown significant abnormalities are found on any of these evaluations, the subject 
will be referred back to their primary care physician with a summary of the findings for 
consideration of further work-up with laboratory testing, neuroimaging, or other testing as 
deemed appropriate by their physician.  
 
C. Outcome Measures 
     Cognitive Measures:  
1. Paper version of SAGE (Scharre, 2010). Subjects will be given one of 4 versions (Forms 
1, 2, 3, or 4) of SAGE. 
2. Digital version of SAGE (eSAGE) (exactly the same questions and format as paper 
version except done on a computer). Subjects will be given the same version (Form 1, 2, 
3, or 4) of SAGE but it will be in digital format (eSAGE). 
3. Mini-Mental State Examination (MMSE) (Folstein, 1965) 
4. Montreal Cognitive Assessment (MoCA) (Nasreddine, 2005) 
5. Boston Naming Test (Kaplan, 1983) 
6. Wisconsin Card Sort Task (WCST) (Berg, 1948) 
7. Hopkins Verbal Learning Test (HVLT). 
8. FAS verbal fluency task (Lezak, 1995) 
9. Wechsler Adult Intelligence Scale III (WAIS III) Letter-number and block design 
subtests 
 
     Behavioral and Functional Measures: 
1. Neuropsychiatric Inventory (NPI) (Cummings, 1994) 
2. Activities of Daily Living (ADL) (Galasko, 1997; Lawton, 1969) 
 
D.  Outcomes/Results 
     Analysis will consist of comparing the subject’s scores on the SAGE in digital and paper 
format to their neuropsychological test scores using correlational methods.  False positive and 
false negative rates for eSAGE will be determined.   We also want to compare the paper with the 
digital format of SAGE to determine if these two formats are equivalent to each other. We aim 
for 80% power with a two-tailed test conducted at 5% level of significance.  A test of the null 
hypothesis of the (Spearman) correlation coefficient being 0.86 against the (lower) threshold of 
0.75 for significant agreement would require 60 subjects.  With 60 subjects we would have a 
power of 85%.  So the proposed sample size of 72 subjects including 20% drop rate would 
provide enough power to validate the e-SAGE forms under the assumed research hypotheses in 
terms of agreement with the paper forms. 
 
Risk-Benefit Analysis 
     The risks to the subjects are very low.  The potential psychological risks would include any 
stress a subject may normally have in having a history, examination, and neuropsychological 
testing performed.  The seriousness of this risk is very low. 
      The possible benefits of this study to the subject include the potential of early detection of 
cognitive impairments. The subjects will also be helping to validate a brief screening tool in 
digital format that may help detect MCI and early dementia in others. 
 
Informed Consent 

 
After subject eligibility for the study has been determined, informed consent will be 
obtained.  If the individual is determined to not have the capacity to consent, assent will be 
obtained from the subject and consent will be obtained by the subject’s legally authorized 
representative (LAR). Each subject and if required their LAR, shall read and sign the instrument 
of informed consent after having had an opportunity to discuss it with the participating physician 
before signing.  The individual signing the informed consent will be informed that the subject 
can withdraw from the program at any time. Written informed consent is required prior to 
enrolling in the study.  The signed consent form is kept at the physician’s office. The consent 
form will be approved by the Institutional Review Board.  It is the responsibility of the 
investigator to obtain consent and to provide the subject/LAR with a copy of the signed and 
dated consent form. 
 
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