Assessing Tools That Predict and Stage Mild Cognitive Impairment
Conditions: Mild Cognitive Impairment (MCI), Alzheimer Dementia (AD), Alzheimer Disease (AD), APOE-4 Positive
Sponsor: Prevention Research Consortium Corp.

   
   
   
 
This is to certify that the information contained herein is true and correct as reflected in the records of WCG IRB. WE CERTIFY 
THAT WCG IRB IS IN FULL COMPLIANCE WITH GOOD CLINICAL PRACTICES AS DEFINED UNDER THE U.S. FOOD AND 
DRUG ADMINISTRATION (FDA) REGULATIONS, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 
REGULATIONS, AND THE INTERNATIONAL CONFERENCE ON HARMONISATION (ICH) GUIDELINES. 
 
Board Action: 03/27/2026 
Page 1 of 2 
  
 
 
Investigator Name: Foster Carr, MD 
 
Board Action Date: 03/27/2026 
Investigator Address: 2534 State Street 305 
San Diego, CA 92103, United States 
Approval Expires: 03/25/2027 
Continuing Review Frequency: Annually 
Sponsor:  Prevention Research Consortium Corporation 
Institution Tracking Number:   
Sponsor Protocol Number: None 
Amended Sponsor Protocol Number:    
Study Number: 1405909 
IRB Tracking Number: 20260518 
Work Order Number: 1-1939855-1 
 
Protocol Title: Assessing Tools that Predict and Stage Mild Cognitive Impairment 
  
THE FOLLOWING ITEMS ARE APPROVED: 
Investigator  
Food for the Brain Cognitive Test (Screenshots) #45775000.0-As Submitted (source: FoodfortheBrain Cognitive Screen 
(2).pdf)  
Protocol (03-05-2026) (source: protocol1.1b)  
PUNTOTEST #45774127.0-As Submitted (source: Copy of PuntoTest_User_Guide_EN)  
Revised Protocol (03-24-2026) (source: IRB Protocol-01.1c)  
Consent Form [Cal0-0]  
Financial Disclosure Form (03-23-2026) Foster Carr  
 
  
Please note the following information: 
The Board requires that all adult participants must be able to consent for themselves to be enrolled in this study.  This 
means that you cannot enroll incapable adult participants who require enrollment by consent of a legally authorized 
representative. 
  
THE IRB HAS APPROVED THE FOLLOWING LOCATIONS TO BE USED IN THE RESEARCH: 
Foster P Carr MD, 2534 State Street 305, San Diego, California  92101    
 
  
ALL IRB APPROVED INVESTIGATORS MUST COMPLY WITH THE FOLLOWING: 
As a requirement of IRB approval, the investigators conducting this research will: 
• 
Comply with all requirements and determinations of the IRB. 
• 
Ensure the consenting process included in the submission is being followed.  Any changes to this process must be 
submitted to the IRB for review 
• 
Protect the rights, safety, and welfare of subjects involved in the research. 
• 
Personally conduct or supervise the research. 
• 
Conduct the research in accordance with the relevant current protocol approved by the IRB. 
• 
Ensure that there are adequate resources to carry out the research safely. 
• 
Ensure that research staff are qualified to perform procedures and duties assigned to them during the research. 
• 
Submit proposed modifications to the IRB prior to their implementation. 
o 
Not make modifications to the research without prior IRB review and approval unless necessary to eliminate 
apparent immediate hazards to subjects. 
• 
For research subject to continuing review, submit continuing review reports when requested by the IRB. 
• 
Submit a closure form to close research (end the IRB’s oversight) when: 
o 
The protocol is permanently closed to enrollment 
o 
All subjects have completed all protocol related interventions and interactions 
o 
For research subject to federal oversight other than FDA: 
Certificate of 
Action 

 
Board Action: 03/27/2026   
Page 2 of 2 
 
No additional identifiable private information about the subjects is being obtained 
 
Analysis of private identifiable information is completed 
• 
For research subject to continuing review, if research approval expires, stop all research activities and immediately 
contact the IRB. 
• 
Promptly (within 5 days) report to the IRB the information items listed in the IRB's "Prompt Reporting Requirements” 
available on the IRB's Web site. 
• 
Not accept or provide payments to professionals in exchange for referrals of potential subjects (“finder’s fees.”) 
• 
Not accept payments designed to accelerate recruitment that are tied to the rate or timing of enrollment (“bonus 
payments”) without prior IRB approval. 
• 
When required by the IRB ensure that consent, permission, and assent are obtained and documented in accordance 
with the relevant current protocol as approved by the IRB. 
• 
Promptly notify the IRB of any change to information provided on your initial submission form. 
• 
Please note that any advertisements or subject material that contain both English and translated content must be 
submitted through the translations process in addition to standard review to have the translated content approved. 
  
Consistent with AAHRPP’s requirements in connection with its accreditation of IRBs, the individual and/or organization shall 
promptly communicate or provide, the following information relevant to the protection of human subjects to the IRB in a 
timely manner: 
• 
Upon request of the IRB, a copy of the written plan between sponsor or CRO and site that addresses whether expenses 
for medical care incurred by human subject research subjects who experience research related injury will be 
reimbursed, and if so, who is responsible in order to determine consistency with the language in the consent document. 
• 
Any site monitoring report that directly and materially affects subject safety or their willingness to continue participation. 
Such reports will be provided to the IRB within 5 days. 
• 
Any findings from a closed research when those findings materially affect the safety and medical care of past subjects. 
Findings will be reported for 2 years after the closure of the research. 
  a 
For Investigator’s Brochures, an approval action indicates that the IRB has the document on file for the research. 
 
  a 
When the Board approves subject materials and/or advertisements, any redline changes that were provided by the submitter or 
required by the Board for approval will remain visible in the outcome document(s); however, recipients are expected to accept 
the tracked changes in the document before using.  Do not make any additional modifications (including font size and visual 
effects) to the approved materials. 
If the IRB approved an e-consent process that involves uploading the approved consent form to an e-consent platform, please 
ensure that the consent form(s) approved for your site is the version of the consent form that gets uploaded to the platform.  
  a 
If the board approves a change of Principal Investigator - Once approved, the new Principal Investigator is authorized by WCG 
IRB to carry out the study as previously approved for the prior Principal Investigator (unless the Board provides alternate 
instructions to the new Principal Investigator).  This includes continued use of the previously approved study materials.  The IRB 
considers the approval of the new PI a continuation of the original approval, so the identifying information about the study 
remains the same. 
  
If your research site is a HIPAA covered entity, the HIPAA Privacy Rule requires you to obtain written authorization from each 
research subject for any use or disclosure of protected health information for research.  If your IRB-approved consent form does 
not include such HIPAA authorization language, the HIPAA Privacy Rule requires you to have each research subject sign a 
separate authorization agreement.  
  a 
If this study includes data monitoring committee/data safety monitoring board, please note that the reports of all meetings of this 
committee should be submitted to the IRB even if the outcome of the meeting results in no changes to the study. 
  a 
For research subject to continuing review, you will receive Continuing Review Report forms from WCG 
IRB when the expiration date is approaching. 
  
Thank you for using WCG IRB to provide oversight for your research project. 
  
DISTRIBUTION OF COPIES: 
Contact, Company 
Foster Carr, MD, Foster P Carr MD  
Gary Strobe, Prevention Research Consortium Corporation   

IRB APPROVED 
Mar 27, 2026 
 
Page 1 of 16 
Informed Consent Form 
 
TITLE: 
Assessing Tools that Predict and Stage Mild Cognitive Impairment 
 
PROTOCOL NO.: 
None  
 
WCG IRB Protocol #20260518 
  
SPONSOR: 
Prevention Research Consortium Corporation 
 
INVESTIGATOR: 
Foster Carr, MD 
 
2534 State Street 305 
  
San Diego, California 92103 
 
United States 
 
STUDY-RELATED 
PHONE NUMBER(S): 
877-271-6078 (24 hours) 
 
 
Your participation in this research study is voluntary.  You may decide not to participate or you may 
leave the study at any time.  Your decision will not result in any penalty or loss of benefits to which 
you are otherwise entitled.  
 
If you have questions, concerns, or complaints, or think this research has hurt you, talk to the 
research team at the phone number(s) listed in this document.  
from this research.  
 
 
 

IRB APPROVED 
Mar 27, 2026 
 
Page 2 of 16 
RESEARCH CONSENT SUMMARY 
 
How long will I be in this research? 
 
We expect that your taking part in this research will last about 24 months (2 years), with in‑person 
visits about every 6 months and continuous or frequent digital monitoring during this time. 
 
Why is this research being done? 
 
The purpose of this research is to test whether a pre‑specified proteogenomic 'Progression and Risk' 
(P&R) model—combining blood‑based biomarkers (including pTau217 and related Alzheimer's 
proteins), genetic risk scores, and digital monitoring—can help predict which cognitively normal or 
very mildly impaired adults with an ApoE4 gene are most likely to develop early memory and 
thinking problems (mild cognitive impairment related to Alzheimer's disease) over about 2 years. 
This is a first-in-human observational study to validate this prediction model. 
 
What happens to me if I agree to take part in this  
 
To determine if you meet criteria for enrollment, you will be evaluated in what is called a  
Screening period where the following will occur:  
 
• 
your current medications will be reviewed as well as your medical record;  
• 
your neurologic or psychiatric history will be reviewed;  
• 
prior ApoE genotyping results will be verified as well as your whole genome sequencing 
(WGS) if available;  
• 
you may be verbally tested for memory and asked about your ability to carry out daily tasks. 
 
If you meet the criteria for participation and decide to take part, you will have 5 in‑person visits over 
about 2 years for blood draws, memory and thinking tests, and digital cognitive assessments. You 
will use digital tools (such as an Oura Ring and smartphone apps with platforms like Punto Health) 
that collect information about your activity, sleep, speech features, and other behaviors on a 
continuous or frequent basis. Some participants may have data collected and used for this research if 
you agree from standard of care procedures such as EEG or retinal imaging, and clinically indicated 
imaging or spinal fluid collection that are performed as part of your standard of care outside of this 
research.  
 
Could being in this research hurt me? 
 
The most important risks or discomforts that you may expect from taking part in this research 
include: 
 
• 
Blood draws: Pain, bruising, bleeding, swelling, feeling faint, or rarely infection at the needle 
or fingerstick site 
• 
Cognitive testing: Tiredness, frustration, or anxiety about performance 
• 
Genetic and biomarker results: Anxiety, sadness, or worry about Alzheimer's risk; small risk 
of information misuse if confidentiality breached 
• 
Continuous digital monitoring: Privacy concerns; risk of unauthorized data access despite 
encryption; some may find monitoring intrusive 
• 
Triggered assessments: Psychological impact of being contacted when data suggest possible 
cognitive changes 

IRB APPROVED 
Mar 27, 2026 
 
Page 3 of 16 
• 
Loss of confidentiality 
• 
Unknown risks: There may be risks not yet known 
 
Will being in this research benefit me? 
 
The most important benefits that you may expect from taking part in this research include: 
 
Direct clinical benefit is not guaranteed. However, you may gain early insights into your cognitive 
status and risk factors through closer monitoring of memory and thinking over time, and you may 
have access to some clinically validated biomarker or genetic results if your site returns them (per 
institutional policy). This study is not designed to provide treatment or change your routine medical 
care. 
 
Possible benefits to others include: 
 
This study may help improve tools for early detection and staging of Alzheimer's disease, enable 
better risk-prediction models, develop more scalable biomarker strategies, and help design future 
prevention or treatment studies. The main benefit is to future patients and society rather than 
individual participants. 
 
What other choices do I have besides taking part in this 
research? 
 
Instead of being in this research, your choices may include: 
 
You may choose not to be in any research study, or you may seek standard evaluation or care for 
memory concerns from your usual healthcare providers or memory clinic, or join other research 
studies for which you are eligible. Your decision will not affect your regular medical care. 
 
What else should I know about this research? 
 
There is a possibility that your de-identified information or biospecimens may be used for future 
research studies. Any future use of your coded samples and data will be reviewed by an ethics board 
when required and will follow applicable privacy laws. You will be asked separately whether you 
agree to future research use; declining does not affect your participation in this main study. 
 
 
 
 

IRB APPROVED 
Mar 27, 2026 
 
Page 4 of 16 
DETAILED RESEARCH INFORMATION 
 
2. Why is this study being done? 
 
This study is being done to learn whether a combination of blood‑based biomarkers, genetic risk 
scores, and continuous digital monitoring (such as measures of activity, sleep, speech patterns, and 
smell) can help predict who is likely to develop very early memory and thinking problems related to 
Alzheimer's disease. 
 
This is a first-in-human observational study designed primarily as a prospective validation of a pre-
specified proteogenomic Progression and Risk (P&R) model for predicting conversion from 
cognitively normal (CN) or very mildly impaired status to pTau217-positive mild cognitive 
impairment (MCI Stage I) over 24 months in ApoE4-positive adults. 
 
The P&R model combines: 
 
• 
A polygenic risk score (PRS) based on your existing whole-genome sequencing or genotyping 
array data 
• 
APOE genotype status (you already carry at least one ApoE4 allele) 
• 
Plasma biomarkers including pTau217, Aβ42/40, GFAP, NfL, and additional proteomic 
markers 
• 
DNA methylation measures in some participants 
• 
Standardized cognitive and functional tests (such as Clinical Dementia Rating and digital 
cognitive assessments) 
• 
Digital and wearable data such as Oura Ring sleep and activity metrics, smartphone-based 
cognitive tasks, and speech features 
 
Please feel free to ask the study staff any questions you may have about this model. 
 
We are especially interested in adults who carry the ApoE4 gene, which is associated with a higher 
chance of developing late‑onset Alzheimer's disease. We will follow participants for about 2 years to 
see who remains cognitively normal and who develops mild changes in memory or thinking (mild 
cognitive impairment, or MCI), and how this relates to the biomarkers and monitoring data. 
 
Up to about 1000 people will take part in this study at this and/or other sites. 
 
3. Why am I being asked to take part? 
 
You are being asked to participate because: 
 
• 
You are 55 years of age or older. 
You already have results from prior genetic testing showing at least one ApoE4 gene copy, 
and you are willing to share your existing genomic data (for example, whole‑genome 
sequencing or genotyping array files from prior clinical testing, research studies, or direct-to-
consumer services) so that a polygenic risk score can be calculated. This protocol does not 
perform new ApoE genotyping or whole-genome sequencing for research purposes. 
You are cognitively normal or very mildly impaired at baseline (the study focuses on 
participants who do not yet meet criteria for established MCI with positive Alzheimer's 
biomarkers; if you develop pTau217-positive MCI during the study, you will be referred to a 
neurologist and your active study participation will end). 

IRB APPROVED 
Mar 27, 2026 
 
Page 5 of 16 
You are willing to undergo blood collection, cognitive testing, and continuous digital 
monitoring (for example through a smartphone and wearable devices). 
You are willing to use wearable devices such as an Oura Ring and smartphone apps, and to 
allow the study to access certain medical record information needed for risk scoring, as 
permitted by you and by privacy regulations. 
 
You do not have to be in this study. You may choose not to participate. 
 
4. What will happen if I take part? 
 
Overview 
 
If you join this study, you will be followed for about 2 years. You will: 
 
• 
Attend 5 in‑person visits at the study site at the beginning (baseline) and at 6, 12, 18, and 24 
months (±2 months). 
• 
Have blood collected up to 5 times over 2 years. 
• 
Complete memory and thinking tests and questionnaires at each in‑person visit. 
 
Use digital tools including an Oura Ring or an Apple Watch (for continuous sleep, activity, 
and heart rate monitoring) and smartphone-based cognitive and speech assessments through 
platforms such as Punto Health and Food for the Brain Cognitive Online Test that measure 
activity, sleep, brief cognitive tasks, speech features (not content), and other behaviors 
continuously or frequently. 
 
Data may also be collected form your medical records if additional procedures (for example, 
spinal fluid collection or brain scan if clinically indicated and ordered by your treating doctor 
regardless of this research). If there is leftover spinal fluid after the clinically indicated 
procedure, you might be asked if the leftover sample can be used for testing in this research 
for biomarkers known to be associated with Alzheimer’s Disease and cognitive decline.  
 
Sub-Cohort of participants may be asked to have non-invasive retinal imaging or EEG 
procedures performed as part of this research. 
 
The total time for each in‑person visit will usually be approximately 1 hour. 
 
Screening 
 
Before you are enrolled, we will: 
 
• 
Ask you about your medical history, medications, and any neurological or psychiatric 
conditions. 
Verify that you have prior ApoE genotype results showing at least one ApoE4 allele 
(documentation from prior clinical or research testing required). 
Verify that you have prior whole‑genome sequencing (WGS) data or equivalent high‑density 
genotyping array data suitable for polygenic risk score (PRS) calculation. 
Ask you to sign a data release authorization allowing the study to obtain WGS/genomic data 
files from your prior testing laboratory, research biobank, or direct‑to‑consumer service (if 
applicable). 
If you have an Oura Ring or an Apple Watch, ask for optional approval to access past and/or 
future Oura Ring data. 

IRB APPROVED 
Mar 27, 2026 
 
Page 6 of 16 
• 
Ask about your memory and daily functioning. 
• 
Possibly administer brief memory tests to make sure the study is appropriate for you. 
 
If you are eligible and still want to participate, you will be asked to sign this consent document and 
proceed to the baseline visit. 
 
Baseline visit (Month 0) 
 
At the baseline visit, you will: 
 
1. Review and sign this consent form (if not already signed). 
2. Medical and neurological evaluation 
o 
Vital signs (blood pressure, pulse, weight, height). 
o 
Brief physical and neurological examination. 
3. Memory and thinking tests 
o 
A structured interview and rating scale about your memory and function (such as the 
Clinical Dementia Rating, or CDR) using a no-informant version when an informant 
is not available. 
o 
A set of paper‑and‑pencil or computerized tests of memory, attention, language, and 
thinking. 
o 
Digital cognitive tests using an app or tablet (for example, through a platform such as 
Punto Health) and brief speech-based measures. 
4. Blood collection 
o 
Blood will be drawn from a vein in your arm and/or by fingerstick. 
o 
Blood will be used to measure Alzheimer's disease biomarkers (for example, a protein 
called pTau217 and related markers including pTau181, Aβ42/40, GFAP, and NfL), 
and to perform proteomic, genomic, and methylation analyses in some participants. 
o 
If needed, some blood may be used for routine safety lab tests or obtained from your 
primary care provider's records. 
5. Genomic data access and PRS calculation 
If your existing genomic data are not yet available to the study, we will ask you to 
authorize release of prior whole‑genome sequencing or genotyping array data from 
the laboratory or service where they were originally performed. This protocol does 
not require new whole‑genome sequencing or new ApoE testing for research 
purposes. Your existing data will be used to calculate a polygenic risk score (PRS) and 
confirm APOE genotype. 
6. Additional data collection from standard of care procedures that were performed outside of 
this research if available (not required for participation; performed only when clinically 
indicated) 
o 
Spinal fluid collection (lumbar puncture): Only if clinically indicated as part of your 
routine care outside the study, a sample of leftover fluid from your lower back may be 
used to measure Alzheimer's‑related proteins. This protocol does not require any 
research-mandated lumbar punctures. 
o 
Retinal imaging (sub-cohort): Imaging of the back of your eye (retina) using a camera 
that may detect changes related to brain health using hyperspectral imaging. 
o 
EEG (electroencephalogram) (sub-cohort): A test that uses small sensors on your 
scalp to measure electrical activity in your brain at rest and during simple tasks (such 
as memory or attention tasks). 
o 
Brain scans (such as amyloid PET): Only if medically indicated and clinically 
available as part of your standard-of-care, your treating doctor may order such scans 
and we may use the results in our research with your permission. MRI or PET scans 
are not required by this study. 

IRB APPROVED 
Mar 27, 2026 
 
Page 7 of 16 
7. Digital monitoring setup 
o 
If you already have an Oura Ring and Apple then you may opt in to allowing 
continuous digital access to these devices for this study.  Connectivity with your 
approval through an installed app that allows connection to the Oura Ring or Apple 
iPhone/Watch Web Site. 
o 
These tools may collect information about your: 
 
Physical activity and step counts. 
 
Sleep patterns (including sleep stages, heart rate variability, and other 
cardiovascular metrics from the Oura Ring). 
 
Location patterns (for example, how often you leave home and where you go, 
but not the content of what you do). 
 
Speech characteristics (for example, pace and tone of your voice, not your 
actual spoken content) collected during brief app-based tasks. 
 
Periodic cognitive assessments and, if available, smell tests, to measure 
cognitive function and sense of smell. 
 
We will help you set up these devices and show you how to use them. 
 
8. Optional Sub-Cohort procedures (not all participants will be asked to have these additional 
procedures performed). 
o 
Retinal imaging (sub-cohort): Imaging of the back of your eye (retina) using a camera 
that may detect changes related to brain health using hyperspectral imaging. 
o 
EEG (electroencephalogram) (sub-cohort): A test that uses small sensors on your 
scalp to measure electrical activity in your brain at rest and during simple tasks (such 
as memory or attention tasks). 
 
Follow‑up visits (Months 6, 12, 18, and 24) 
 
At each follow‑up visit, you will: 
 
• 
Update your medical history and medications. 
• 
Have vital signs measured. 
• 
Repeat memory and thinking tests similar to the baseline visit. 
• 
Repeat digital cognitive tasks and brief speech-based measures. 
• 
Have blood drawn again (venipuncture or fingerstick) for biomarker and other tests 
including pTau217 and related biomarkers, with extended proteomic and methylomic panels 
performed in some participants as budget permits. 
• 
Discuss any problems or questions about the digital devices and review your Oura Ring or 
Apple IPhone/Watch and app adherence. 
 
Some procedures (such as EEG or retinal imaging) may be repeated at selected visits (for example, at 
24 months) depending on feasibility and your willingness and are limited to sub-cohorts. 
 
Continuous digital monitoring 
 
During the 2‑year study: 
 
• 
You will be asked to use a smartphone app and/or wearable sensors most days including 
continuous or frequent Oura Ring wear and periodic completion of app-based cognitive and 
speech tasks. 
• 
The devices will passively measure some aspects of your behavior (activity, sleep, location 
patterns) and sometimes ask you to complete brief tasks or questions. 
• 
The study team may contact you if the data suggest notable changes in your functioning, or if 
you are not using the devices regularly, to see if you are having any difficulties. 

IRB APPROVED 
Mar 27, 2026 
 
Page 8 of 16 
 
If you have any questions or concerns using the Oura Ring or the iPhone App, please contact the 
study team for assistance. 
 
Additional "triggered" assessments 
 
If there are concerns about new memory or thinking problems---for example, because of changes in 
your test scores, digital data, or your own report---we may invite you for an extra visit. At that visit, 
you may repeat some of the cognitive tests and blood tests, and if criteria for pTau217-positive MCI 
are met, you will be referred to a neurologist and your active participation in the study will end, 
though samples and data already collected may continue to be used for research. 
 
5. How long will I be in the study? 
 
Your participation in this study will last about 24 months (2 years) from your baseline visit. At the 
end of the 2 years, your active participation in this study will stop. If you develop pTau217-positive 
MCI during the study and are referred to a neurologist, your active participation may end earlier. In 
all cases, your samples and data may continue to be used for research as described below if you 
provide separate permission for future use. 
 
You may choose to leave the study earlier at any time. 
 
6. What are the risks and discomforts? 
 
Taking part in this study may involve the following risks or discomforts: 
 
Blood draws (venipuncture or fingerstick) 
 
• 
Pain, bruising, bleeding, or swelling at the needle or fingerstick site. 
• 
Feeling light‑headed or faint. 
• 
Very rarely, infection or inflammation at the puncture site. 
 
EEG (sub-cohort procedure) 
 
• 
Mild discomfort from wearing a cap and having electrodes on your scalp. 
• 
Possible skin irritation from the gel or adhesive. 
• 
Fatigue from sitting still. 
 
Retinal imaging (sub-cohort procedure) 
 
• 
Bright lights may be uncomfortable and could cause temporary blurry vision or sensitivity to 
light. 
• 
Eye drops (if used) may temporarily blur your vision. 
 
Cognitive testing 
 
• 
Some people feel tired, frustrated, or anxious during or after memory and thinking tests. 
• 
You may worry about your performance or what it means. 
 

IRB APPROVED 
Mar 27, 2026 
 
Page 9 of 16 
Genetic testing and biomarker results 
 
• 
Learning (or knowing) that you carry ApoE4 or have biomarker changes associated with 
Alzheimer's disease may cause anxiety, sadness, or worry about the future. 
• 
There is a small risk of misuse or misunderstanding of genetic or biomarker information by 
others if confidentiality is breached, although we take steps to protect your information. 
 
We will explain which results, if any, will be shared with you and under what circumstances. You can 
choose not to learn certain results if allowed by law and IRB policy. 
 
Digital monitoring (there is a risk of loss of privacy and confidentiality) 
 
• 
Your activity, location patterns, sleep, speech features (not content), and other sensor-based 
signals including Oura Ring cardiovascular and sleep metrics will be collected electronically. 
• 
Although we use encryption and secure systems, there is a risk of unauthorized access or data 
breach. 
• 
You may find some aspects of continuous monitoring intrusive or bothersome. 
• 
Being contacted for a triggered assessment when digital data suggest possible cognitive 
changes may cause psychological distress or worry. 
 
You may choose to disable or pause some monitoring temporarily; however, this may limit how 
much data we can use for the study. You may choose not to take part in specific optional procedures 
(EEG, retinal imaging, or certain digital features) and still remain in other parts of the study, when 
feasible and allowed by the protocol. 
 
The following procedures would only be performed as part of your standard of care treatment and 
regardless of this research.  These risks are outside of this research context. 
 
Lumbar puncture (if clinically indicated and ordered by your treating physician as standard of care) 
 
• 
This procedure will be only performed when clinically indicated as part of your routine care 
and regardless of this research. 
• 
Headache after the procedure. 
• 
Back discomfort. 
• 
Rarely, bleeding, infection, or nerve injury. 
 
Brain imaging (if clinically indicated and ordered by your treating physician as standard of care) 
 
• 
These scans are only performed when ordered by your treating physician as part of routine 
care and regardless of this research. 
• 
MRI: discomfort from lying still, noise, or claustrophobia; in very rare cases, contrast agents 
can cause allergic reactions or kidney problems. 
• 
PET: exposure to low levels of radiation, similar to or less than many diagnostic imaging 
procedures; rare allergic reactions to the tracer. 
 
Other risks 
 
• 
There may be risks that are unknown or unexpected at this time. 
• 
If we learn of new risks or important new information that might affect your willingness to 
continue, we will tell you. 
 

IRB APPROVED 
Mar 27, 2026 
 
Page 10 of 16 
7. Are there benefits to taking part? 
 
You may or may not receive any direct benefit from being in this study. 
 
Possible personal benefits may include: 
 
• 
Learning more about your memory and thinking over time. 
• 
Having access to some biomarker or genetic information that might not otherwise be 
available, if your site's policy is to share such results. 
• 
Being more closely monitored for early changes in memory and function, which you can 
discuss with your healthcare providers. 
 
However, this study is not designed to provide treatment and may not improve or change your 
health. You may gain early insights into your cognitive status and risk factors through closer 
monitoring, though this study is not designed to provide treatment or change your routine medical 
care. 
 
The information learned from this study may help researchers better understand how to detect 
Alzheimer's disease at its earliest stages and may help design future prevention or treatment studies. 
The main benefit is to future patients and society via better risk-prediction models, more scalable 
biomarker strategies, and improved early detection tools. 
 
8. What other choices do I have besides taking part in this 
research? 
 
You may choose not to be in any research study, or you may seek standard evaluation or care for 
memory concerns from your usual healthcare providers or memory clinic, or you can join other 
research studies for which you are eligible. Your decision will not affect your regular medical care. 
 
9. What about privacy and confidentiality? 
 
We will do our best to protect your privacy and the confidentiality of your information. 
 
• 
You will be assigned a unique study number. Your samples and most data will be labeled with 
this number instead of your name whenever possible. 
• 
A master list that links your name to your study number will be kept in a secure, 
limited‑access file. 
• 
Electronic data (including digital monitoring data) will be stored on secure systems with 
password protection, encryption, and access limited to authorized study staff. 
• 
Paper records will be kept in locked cabinets or offices. 
 
For digital data such as Oura Ring or Apple IPhone/Watch metrics or app-based cognitive tests, data 
will be transmitted over encrypted connections to secure servers and stored under coded identifiers. 
Any sharing with collaborators or sponsors will use de-identified or limited datasets under data-use 
agreements that prohibit re-identification. 
 
People who may see your study records include: 
 
• 
The research team and staff at the study site.  
• 
Institutional review boards (IRBs) and other institutional committees that oversee research. 

IRB APPROVED 
Mar 27, 2026 
 
Page 11 of 16 
• 
Regulatory agencies (for example, the U.S. Food and Drug Administration) if required by 
law. 
• 
Study sponsors or collaborators, in de‑identified or limited data form, under data‑sharing 
agreements designed to protect your privacy. This includes academic research collaborators 
and commercial partners involved in model development and biomarker analysis. 
 
When we publish or present study results, we will not use your name or any information that could 
easily identify you. 
 
10. Will my information or samples be used for future research? 
 
As part of this study, we will collect blood (and possibly spinal fluid) and detailed digital and clinical 
data. These may be stored for future research. 
 
• 
Future research may be related to Alzheimer's disease, other brain or aging conditions, or to 
the development of new tests or models. Future studies may be conducted with or without 
Alzheimer's disease as the primary focus, as long as they are IRB-approved. 
• 
Any future use of your samples or data will follow applicable laws and will be reviewed by a 
research ethics board when required. 
 
You will be asked to indicate whether you agree to allow your samples and data (with your 
identifying information removed or coded) to be stored and used for future research. You may: 
 
• 
Agree to future use, or 
• 
Decline future use (in which case, your samples will be destroyed at the end of this study or 
as per institutional policy). 
 
Your decision about future use will not affect your participation in this main study. 
 
12. Will any results be returned to me? 
 
Whether and how individual results are returned to you (for example, ApoE status, pTau217 levels, 
imaging findings) depends on institutional policies, laboratory certification, and IRB guidance. 
 
In general: 
 
• 
If results are clinically validated, clearly interpretable, and considered potentially important 
to your health, we may offer to share them with you and, with your permission, with your 
healthcare provider. 
• 
Some research‑only tests may not be suitable for clinical decision‑making and may not be 
returned. 
• 
We will tell you, during the consent discussion, which types of results may be returned and 
how. 
 
Any decision to share individual genetic or biomarker results (such as ApoE status, polygenic risk 
scores, or pTau217 levels) will follow institutional policies, laboratory certification requirements, and 
IRB guidance, and will be discussed with you, including options to decline certain results when 
allowed by law. 
 
You may choose not to receive certain kinds of results if allowed by law. 
 

IRB APPROVED 
Mar 27, 2026 
 
Page 12 of 16 
13. What happens if I am injured? 
 
This is mainly an observational study with procedures similar to those used in standard medical care. 
Injury from study procedures is unlikely but possible (for example, from blood draws). 
 
If you are injured as a direct result of study procedures, medical care will be available. Your site will 
explain whether financial compensation or coverage for such injury is available under institutional 
policy. If you are injured as a result of this study, you do not give up your right to pursue a claim 
through the legal system. 
 
 
 
14. Do I have to be in this study? What if I change my mind? 
 
Participation is voluntary. 
 
• 
You may choose not to be in the study. 
• 
If you decide to be in the study, you may leave at any time, for any reason, without penalty. 
• 
Your decision will not affect your legal rights or your regular medical care. 
 
If you leave the study, we may continue to use information and samples already collected unless you 
specifically withdraw permission for this use, as allowed by law and institutional policy. 
 
The study doctor may also decide to stop your participation without your consent if: 
 
• 
You are unable to follow study instructions. 
• 
You develop a medical condition that makes continued participation unsafe. 
• 
The study is stopped by the sponsor, the institution, or the IRB. 
 
15. Who can answer my questions? 
 
If you have questions, concerns, or complaints, or think this research has hurt you, talk to the research 
team at the phone number(s) listed in this document. 
 
This research is being overseen by WCG IRB. An IRB is a group of people who perform independent 
review of research studies. You may talk to them at 855-818-2289 or clientcare@wcgclinical.com if: 
 
• 
You have questions, concerns, or complaints that are not being answered by the research team. 
• 
You are not getting answers from the research team. 
• 
You cannot reach the research team. 
• 
You want to talk to someone else about the research. 
• 
You have questions about your rights as a research subject. 
 
16. Will I be paid to participate? 
 
You will not be paid for being in this study.  
 

IRB APPROVED 
Mar 27, 2026 
 
Page 13 of 16 
17. Consent and Authorization 
 
By signing below, you: 
 
• 
Confirm that you have read this form (or had it read to you). 
• 
State that all your questions have been answered. 
• 
Understand that your participation is voluntary. 
• 
Agree to take part in this research study. 
 
You will receive a copy of this signed and dated form, as well as signed and dated copy of the 
Experimental Subject’s Bill of Rights. 
 
 
Participant Name (print): _________________________________ 
 
 
Participant Signature: _________________________________ Date: ____________ 
 
 
Person Obtaining Consent (print): _________________________________ 
 
 
Signature of Person Obtaining Consent: _____________________ Date: ____________ 
 
 
17.1 Optional: Permission for Future Use of Samples and Data 
 
Please initial one option: 
 
_____ YES, I agree that my coded samples and data may be stored and used for future research 
related to brain health, aging, or related conditions, as approved by an ethics board. 
 
_____ NO, I do not agree to future research use of my samples and data beyond this study. I 
understand that my participation in the main study is still allowed. 
 
 
Participant Signature (for this section): ____________________________________ Date: ____________ 
 
 
17.2 Optional: Permission to Access Oura Ring Data 
 
Please initial one option: 
 
_____ YES, I agree that deidentified Oura Ring Data may be stored and used for future research 
related to brain health, aging, or related conditions, as approved by an ethics board. 
 
_____ NO, I do not agree to future research use of my Oura ring data beyond this study. I 
understand that my participation in the main study is still allowed. 
 
 
Participant Signature (for this section): ____________________________________ Date: ____________ 
 

IRB APPROVED 
Mar 27, 2026 
 
Page 14 of 16 
 
17.3 Optional: Permission for Retrieval and Use of Apple Health 
Data 
 
Please initial one option: 
 
_____ YES, I agree that my Apple Health Data may be used by this study, as approved by an ethics 
board. 
 
_____ NO, I do not agree that my Apple Health Data may be used by this study I understand that 
my participation in the main study is still allowed. 
 
 
Participant Signature (for this section): ____________________________________ Date: ____________ 
 
 
17.4 Optional: Permission to Retrieval of Data from Standard of 
Care Imaging or Lumbar Puncture Procedures or to use leftover 
Spinal Fluid from a Lumbar Puncture Procedure. 
 
Please initial one option: 
 
_____ YES, I agree that my data from the above referenced procedures may be used by this study, 
as approved by an ethics board. 
 
_____ NO, I do not agree that my data from standard of care imaging or lumbar puncture 
procedures and leftover spinal fluid sample may be used by this study I understand that my 
participation in the main study is still allowed. 
 
 
Participant Signature (for this section): ____________________________________ Date: ____________ 
 
 
17.5 Optional: Permission for Retrieval of Data Obtained from 
Optional Retinal Imaging or EEG Procedures 
 
Please initial one option: 
 
_____ YES, I agree that my data from the optional retinal imaging or EEG procedures may be used 
by this study, as approved by an ethics board. 
 
_____ NO, I do not agree that my data from the optional retinal imaging or EEG procedures may be 
used by this study I understand that my participation in the main study is still allowed. 
 
 
Participant Signature (for this section): ____________________________________ Date: ____________ 
 
 
 

IRB APPROVED 
Mar 27, 2026 
 
Page 15 of 16 
AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR 
RESEARCH PURPOSES  
 
What information may be used and given to others? 
The study doctor will get your personal and medical information.  For 
example:  
• Past and present medical records 
• Research records 
• Records about phone calls made as part of this research 
• Records about your study visits. 
 
Who may use and give out information about you? 
The study doctor and the study staff.  They may also share the research 
information with an agent for the study doctor, if applicable. 
 
Who might get this information? 
The sponsor of this research.  “Sponsor” means any persons or companies 
that are: 
• working for or with the sponsor, or  
• owned by the sponsor. 
 
Your information may be given to:  
• The U.S. Food and Drug Administration (FDA), 
• Department of Health and Human Services (DHHS) agencies, 
• Governmental agencies in other countries,  
• The institution where the research is being done, 
• Governmental agencies to whom certain diseases (reportable diseases) 
must be reported, and 
• Institutional Review Board (IRB)  
 
Why will this information be used and/or given to others? 
• to do the research,  
• to study the results, and  
• to make sure that the research was done right.   
 
If the results of this study are made public, information that identifies you 
will not be used. 
 

IRB APPROVED 
Mar 27, 2026 
 
Page 16 of 16 
What if I decide not to give permission to use and give out my health 
information? 
Then you will not be able to be in this research study. 
 
May I review or copy my information? 
Yes, but only after the research is over.  
 
May I withdraw or revoke (cancel) my permission? 
This permission will be good until December 31, 2070. 
 
You may withdraw or take away your permission to use and disclose your 
health information at any time.  You do this by sending written notice to the 
study doctor.  If you withdraw your permission, you will not be able to stay 
in this study. 
 
When you withdraw your permission, no new health information 
identifying you will be gathered after that date.  Information that has 
already been gathered may still be used and given to others.   
 
Is my health information protected after it has been given to others? 
There is a risk that your information will be given to others without your 
permission. 
 
Authorization: 
I have been given the information about the use and disclosure of my health 
information for this research study.  My questions have been answered. 
 
I authorize the use and disclosure of my health information to the parties 
listed in the authorization section of this consent for the purposes described 
above. 
 
AUTHORIZATION SIGNATURE: 
 
 
 
 
 
 
Signature of Participant 
Date