Duke/UNC Alzheimer's Disease Center Clinical Cohort
Conditions: Alzheimer Disease, Mild Cognitive Impairment, Dementia
Sponsor: Duke University

DUHS IRB Application (Version 1.98) - Document Date 14AUG2025
General Information
*Please enter the full title of your protocol:
Duke Alzheimer's Disease Center Clinical Cohort (Duke as Single IRB of Record)
*Please enter the Short Title you would like to use to reference the study:
ADRC Clinical Cohort (Duke as Single IRB)
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this
study.
Add Study Organization(s):
List Study Organizations associated with this protocol:
Primary 
Dept?
Department Name
DUHS - Behavioral Neurology
DUHS - Center for Study of Aging
DUHS - Geriatric Behavioral Health
DUHS - Medicine-General Internal Medicine
Assign key study personnel (KSP) access to the protocol
* Please add a Principal Investigator for the study:
(Note: Before this study application can be submitted, the PI MUST have completed CITI training)
Whitson, Heather
3.1 If applicable, please select the Key Study personnel: (Note: Before this study application can be submitted, all Key 
Personnel MUST have completed CITI training)
* Denotes roles that are not recognized in OnCore. Please select an appropriate role that is recognized in all clinical
research applications (iRIS, OnCore, eREG, etc.)
A) Additional Investigators, Primary Study Coordinator (CRC), and the Primary Regulatory
Coordinator (PRC):
B) All Other Key Personnel
Ayoub, Chakib 
Sub-Investigator
Bauer, Melissa 
Sub-Investigator
N

Beakas, Jenna Ashley 
 Study Coordinator (CRC/CRNC/RPL)
Blach, Colette 
 Analyst*
Bottiger, Brandi 
 Sub-Investigator
Bullock, William 
 Sub-Investigator
Carlson, Jessica 
 Clinical Research Specialist/Study Assistant
Cherry, Anne 
 Sub-Investigator
Chesnut, Blair 
 Analyst*
Cobb, Sandra 
 Nurse Practitioner
Connolly, Erin 
 Clinical Research Specialist/Study Assistant
Davis, Scott 
 Data Manager
Devinney, Michael 
 Sub-Investigator
Dewees, Rachel 
 Clinical Research Specialist/Study Assistant
Dooley, Joshua 
 Sub-Investigator
Einhorn, Lisa 
 Sub-Investigator
Eleswarpu, Sarada 
 Sub-Investigator
Ervin, John 
 Analyst*
Fekrat, Sharon 
 Collaborator
Fleenor, Julie 
 Clinical Research Specialist/Study Assistant
Gadde, Syam 
 Analyst*
Gadsden, Jeffrey 
 Sub-Investigator
Ghosh, Dhrubajyoti 
 Analyst*
Ghosh, Dhrubajyoti 
 Statistician
Habib, Ashraf 
 Sub-Investigator
Hauser, Elizabeth 
 Analyst*
Hecker, Emily 
 Study Coordinator (CRC/CRNC/RPL)
Hennon, Leila 
 Study Coordinator (CRC/CRNC/RPL)
Hinnant, Brittany 
 Clinical Research Specialist/Study Assistant
Hsia, Bethany 

 Laboratory Manager
Johnson, Kim 
 Sub-Investigator
Jones, Rodney 
 Analyst*
Kent, Michael 
 Sub-Investigator
Klinger, Rebecca 
 Sub-Investigator
Koner, Salil 
 Statistician
Krom, Russell-John 
 Sub-Investigator
Ladner, Kelcey 
 Study Coordinator (CRC/CRNC/RPL)
Liu, Andrew 
 Sub-Investigator
Luo, Sheng 
 Analyst*
Lutz, Michael 
 Sub-Investigator
MacDonald, Heather 
 Data Manager
Melcher, Jennifer 
 Graduate Student
Meng, Marie-Louise 
 Sub-Investigator
Merenstein, Jenna 
 Collaborator
Miller, Marshall 
 Study Coordinator (CRC/CRNC/RPL)
Moretti, Eugene 
 Sub-Investigator
O'Brien, Richard 
 Sub-Investigator
Ohlendorf, Brian 
 Sub-Investigator
Patillo, Sara 
 Study Coordinator (CRC/CRNC/RPL)
Plassman, Brenda 
 Sub-Investigator
Potter, Guy 
 Sub-Investigator
Rodgers, Beverly 
 Study Coordinator (CRC/CRNC/RPL)
Sasannejad, Cina 
 Sub-Investigator
Serbanescu, Mara 
 Sub-Investigator
Shields, Thomas 
 Study Coordinator (CRC/CRNC/RPL)
Song, Allen 
 Sub-Investigator
Songdechakraiwut, Tananun 
 Analyst*

Tunstall, LeeAnne 
 Study Coordinator (CRC/CRNC/RPL)
Wang, Shih-Hsiu 
 Sub-Investigator
Welsh-Bohmer, Kathleen 
 Collaborator
Williams, Cierra 
 Study Coordinator (CRC/CRNC/RPL)
Williams, Cierra 
 Regulatory Coordinator
Young, Christopher 
 Sub-Investigator
Yurashevich, Mary 
 Sub-Investigator
Zhao, Wufan 
 Clinical Research Specialist/Study Assistant
*Please add a Study Contact:
 
Hennon, Leila 
Hinnant, Brittany 
Johnson, Kim 
Ladner, Kelcey 
Patillo, Sara 
Whitson, Heather 
Williams, Cierra 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g., The study contact(s) are typically the Principal Investigator, Study Coordinator, 
and Regulatory Coordinator.) 
 
Oncore
Please select the Library for your Protocol:
This field is used in OnCore and determines the Reference Lists, Forms, Protocol Annotations, Notifications, 
and Signoffs available for the protocol. Protocols that require reporting to the NCI (National Cancer Institute), 
must select the Oncology library.
Oncology 
Non-Oncology 
 
Protocol Application Type
Select the type of protocol you are creating:
Please see additional criteria and information in the policy titled, “Reliance on the IRB of Another Institution, 
Organization, or an Independent IRB", on the 
.
IRB web site
Regular Study Application - Most common. The IRB will determine if the study is eligible for expedited 
review or requires full board review upon submission. 
Application for Exemption from IRB Review - Includes Exempt, Not Human Subject Research, & Not 
Research. 
External IRB Application - Any study using an external IRB as the IRB-of-Record. 
Trainee Research While Away from Duke - Research conducted by medical students overseen by the 
Office of Curriculum & other student/trainee research away from Duke. 

Individual Patient Expanded Access, Including Emergency Use - Use of an investigational product 
under expanded access, including emergency use of an investigational drug or biologic or emergency 
use of an unapproved device. 
 
Conflict of Interest
Are any key personnel an inventor of any of the drugs, devices or technologies used in this research?
  Yes   
  No
Do any key personnel have a conflict of interest management plan issued by DOSI-COI related to this 
research?
  Yes   
  No
 
Oversight Organization Selection
CRU (Clinical Research Unit) or Oversight Organization Selection:
Please select the CRU.
Medicine
The Clinical Research Unit that takes responsibility for this study.
Please select 
as the CRU 
if the PI is in one of these Divisions or Institutes: 
Medicine 
only 
Endocrinology, Gastroenterology, General Internal Medicine, Geriatrics, Hematology, Infectious 
Diseases, Nephrology, Pulmonary, Rheumatology & Immunology, Center for Applied Genomics and 
Precision Medicine, Center for the Study of Aging and Human Development, Duke Molecular Physiology 
Institute.
More information on CRUs can be found on the Duke Office of Clinical Research (DOCR) website, 
http://docr.som.duke.edu
Questions concerning CRU selection should be directed to docr.help@dm.duke.edu.
For questions about the Campus Oversight Organization, please visit Campus Oversight 
.
Organization
EXTERNAL KEY PERSONNEL (KP) TOOL
Use the following External KP Tool to determine 
 time you consider adding outside Key Personnel. You 
each
will need to clear your responses to the following 2 questions each time.
List all Key Personnel on the study who are outside Duke if they are engaged in research and 
relying on the DUHS IRB: (Consider these questions every time you add external key personnel)
If you have additional personnel, use the External KP Tool as a guide to determine if the 
personnel are engaged in research.  Only people ENGAGED IN RESEARCH should be added as 
external key personnel.
Are the personnel intervening or interacting with the participant?
  Yes   
  No
Are the personnel obtaining or receiving identifiable private information or protected health information (PHI)?
  Yes   
  No

       Entry 1       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Dr. Heidi Roth
Study Role
Sub-Investigator
Email Address
Hroth@neurology.unc.edu
Institution / Organization
UNC-CH
       Entry 2       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Robert Huynh
Study Role
UNC PET SubI
Email Address
rhuynh@med.unc.edu
Institution / Organization
UNC - Radiation Safety Committee Chair
       Entry 3       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Weili Lin
Study Role
UNC SubI
Email Address
weili_lin@med.unc.edu
Institution / Organization
UNC, Biomedical Research Imaging Center (BRIC)
       Entry 4       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.

Name
Gwenn Garden
Study Role
Co-Investigator - Center Director at UNC
Email Address
gagarden@email.unc.edu
Institution / Organization
UNC-CH
       Entry 5       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Andrea Bozoki
Study Role
Co-Investigator
Email Address
abozoki@unc.edu
Institution / Organization
UNC-CH
       Entry 6       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Mason Morgan
Study Role
Psychometrist
Email Address
morganm@neurology.unc.edu
Institution / Organization
UNC-CH
       Entry 7       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Patrick Smith
Study Role
Sub-Investigator
Email Address
smith562@mc.duke.edu
Institution / Organization
UNC-CH
       Entry 8       

Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Tiffany Kollah
Study Role
CRC
Email Address
tkolla@unc.edu
Institution / Organization
UNC-CH
       Entry 9       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Indira Lujano
Study Role
Research Assistant
Email Address
indira@live.unc.edu
Institution / Organization
UNC-CH
       Entry 10       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Jessica Ferrall
Study Role
Study Coordinator
Email Address
jferrall@neurology.unc.edu
Institution / Organization
UNC-CH
       Entry 11       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Indira Lujano
Study Role
Study Coordinator

Email Address
indara@live.unc.edu
Institution / Organization
UNC-CH
       Entry 12       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Mackenna Moore
Study Role
Duke - CRISP Intern
Email Address
mackenna.moore@duke.edu
Institution / Organization
Durham Technical Community College
       Entry 13       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Mary Sutton Sallenger
Study Role
CRC
Email Address
sallengers@neurology.unc.edu
Institution / Organization
UNC-CH
       Entry 14       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Anna Brey
Study Role
Physician Assistant
Email Address
abrey@email.unc.edu
Institution / Organization
UNC-CH
       Entry 15       
Confirm by checking this 
box, the person you are 
adding to this section is 

engaged in the research 
based upon the two 
questions above.
Name
Madelyn Vavrousek
Study Role
CRC
Email Address
vavrousekm@neurology.unc.edu
Institution / Organization
UNC-CH
       Entry 16       
Confirm by checking this 
box, the person you are 
adding to this section is 
engaged in the research 
based upon the two 
questions above.
Name
Julianne Key
Study Role
Regulatory Monitor
Email Address
keyj@neurology.unc.edu
Institution / Organization
UNC-CH
Describe Role of External Personnel:
Tiffany Kollah, Mary Sutton Sallenger, and Madelyn Vavrousek will be assisting with Subject Recruitment 
from UNC clinics, as well as collaborating with Duke staff regarding subjects doing assessments at UNC. 
They are being assisted by additional primary research assistants who will be included as listed external KP 
as well. Dr. Heidi Roth is presently involved as a SubI/Collaborator.  All PHI data sharing will be in 
accordance with executed data agreements, as well as any related language in the study consents, RDSP, 
and study application regarding that sharing, specifically between Duke and UNC as part of their ADRC 
collaboration. The primary intent is that Duke and UNC be able to share subject data/information for 
purposes of coordinated recruitment efforts as well as Clinical Case Consultations.
Drs. Weili Lin and Robert Huynh are both acting SubIs at UNC, assisting with activities related to imaging 
at the BRIC.
Drs. Gwenn Garden, Patrick Smith, and Andrea Bozoki are all SubIs based at UNC, and Mason Morgan is 
based at UNC and has the role of Psychometrist.
Mackenna Moore is a Durham Technical Community College, Clinical Research Student, who will be 
interning at the ADRC for Summer 2025. She will be observing study visits and aiding in managing study 
resources (e.g., creating blood collection kits, printing documents for data collection, etc.)
Anna Brey is a Physician Assistant as a study clinician. She will complete neurological exams at UNC-CH.
Julianne Key is a regulatory monitor at UNC-CH. She will be completing regulatory monitoring at UNC-CH. 
Indicate the Protocol source below:
The protocol source is the author of the protocol. If the protocol is a joint authorship between multiple 
sources, select the primary author. 
An IRB fee may be assessed for all research that is supported by for-profit entities and requires full board 
review. For additional information, see the 
.
IRB fees section of the IRB web site

Duke PI initiated 
Commercial / Industry (for-profit entity) initiated 
Federal Government initiated 
Cooperative Group Initiated 
Foundation (non-profit group) initiated 
Other 
 
Sponsor and Funding Source
Add all funding sources for this study: (Select 'Duke University' if you do not have funding or a sponsor for 
your study).
View 
Details
Sponsor Name
Sponsor Type
Contract 
Type:
Project 
Number 
Award Number 
Duke University 
Institutional 
Grant 
 
 
Sponsor Name:
Duke University 
Sponsor Type:
Institutional 
Sponsor Role:
Funding
Grant/Contract Number:
 
Project Period:
From:08/30/2019   to:09/30/2020 
Is Institution the Primary Grant 
Holder:
No 
if No, then who is the Primary 
Grantee?
Neuroscience Translating Duke Health grant 
Contract Type:
Grant 
Project Number:
 
Award Number:
 
Grant Title:
Creating a clinical core model for the Alzheimer's Disease 
Research Center 
PI Name:
(If PI is not the same as identified 
on the study.)
 
Explain Any Significant 
Discrepancy:
 
National Institute on 
Aging 
Federal Government 
Grant 
 
1P30AG072958-
01 
Sponsor Name:
National Institute on Aging 
Sponsor Type:
Federal Government 
Sponsor Role:
Funding
Grant/Contract Number:
 
Project Period:
From:09/01/2021   to:06/30/2026 
Is Institution the Primary Grant 
Holder:
Yes 
Contract Type:
Grant 
Project Number:
 
Award Number:
1P30AG072958-01 
Grant Title:
Duke/UNC Alzheimer's Disease Research Center 
PI Name:

(If PI is not the same as identified 
on the study.)
 
Explain Any Significant 
Discrepancy:
 
Is this a federally funded study?
 Yes   
 No
Does this study have any of the following?
Industry sponsored protocol
Industry funded Duke protocol
Industry funded sub-contract from another institution
Industry provided drug/device/biologic
SBIR/STTR funded protocol
 
  Yes   
  No
As part of this study, will any samples or PHI be transferred to/from Duke to/from anyone other than the 
Sponsor, a Sponsor subcontractor, or a Funding Source?
 Yes   
 No
Is the Department of Defense (DOD) a funding source?
  Yes   
  No
For Federally funded studies:
Is your funding subject to, and does it comply with, the funding agency's policy for data sharing?
 Yes   
 No
Check all that apply:
 
NIH Genome Sharing - dbGaP
NIH Genome Sharing - GWAS
NIH Genome Sharing - NCI databases
NIH Genome Sharing - other
Non-NIH Genomic
General Data Sharing
Enter the Grant Number or Other Federal Agency Proposal or Application Number:
1P30AG072958-01
Note: The Federal Funding Agency ID Number is the Sponsor's grant number assigned to your project and 
available on your Notice of Award (example: R01HL012345).
 
If known, enter the SPS (Sponsored Projects System) number if applicable:
0

In the Initial Submission Packet, attach the following:
(1) The entire grant, or an explanation of why a grant is not needed. 
(2) NIH institutional Certificate form related to data sharing (if applicable).
 
Mobile Devices and Software
Does this study involve the use of a software or a mobile application?
 Yes   
 No
Please describe the following:
The developer of the mobile app and how the app will be obtained.
What PHI will be collected via the app.
Where the data will be stored and who will have access to it.
N/A
List all software, including third party (non-Duke) and mobile apps, that will be utilized for ascertainment, 
recruitment, or conduct of the research/project: (eg, MaestroCare, DEDUCE):
Duke Qualtric
Duke Drop Box
Duke REDCap
PEDIGENE (part of ARENA data management system)
Duke MaestroCare
Sony ICD-UX560 or ICD-PX470 Stereo Digital Voice Recorder (or other similarly encrypted alternatives)
GlobalApp
VRFCAT (utilizing company provided iPads)
Are you using FCAP (Federated Clinical Analytics Platform) for this study?
  Yes   
  No
 
Multi-site Research
Is this a multi-site study?
 Yes   
 No
Is the Duke PI/Co-PI the lead investigator or primary grant awardee?
 Yes   
 No
Is the primary grant awardee a Duke employee?

 Yes   
 No
Is a Duke employee the holder of the IND or IDE?
Yes 
No 
N/A 
Is Duke the central coordinating center for this study?
 Yes   
 No
Is Duke serving as a central statistical center for this study?
 Yes   
 No
Is Duke serving as a central laboratory, reading center, analysis center or other central resource for this 
study?
 Yes   
 No
Do you have ten or more sites?
  Yes   
  No
Complete for each site if Duke is the Primary grant awardee or coordinating center:
       Entry 1       
Site Name:
UNC-CH
City:
Chapel Hill
State/Province:
NC
Country:
USA
Site Contact Information
Primary Contact Name:
Weili Lin
Primary Contact Phone:
919-843-8120
Primary Contact Email:
weili_lin@med.unc.edu
Site Details

Does the site have an IRB?
 Yes   
 No
Site IRB approval expiration 
date:
01/29/2026
If date not provided, 
explanation of why:
Has the site granted 
permission for the research 
to be conducted?
 Yes   
 No
Does the site plan to rely on 
the DUHS IRB for review?
 Yes   
 No
What is the status of the 
study at this site?
Open 
Closed 
Site approval letters or site 
personnel lists:
Attach site approval letters, site closure letters (if applicable), or site 
personnel lists in the Initial Submission Packet.
Provide a description of the procedures that will be used to inform sites of unanticipated problems involving 
risks to subjects or others, interim results, protocol modifications and other information that may be 
relevant to the protection of subjects:
The PI at Duke (Dr. Whitson) will be the centralized contact to coordinate communication between the 
sIRB at Duke and other sites/local IRBs. She will spearhead monthly conference calls attended by the PIs 
at each site, as well as weekly meetings with the Clinical teams and Core Leaders. As relevant, additional 
team members, including Project Coordinators, will participate in such meetings. An agenda item will be 
included during each call for discussion or update regarding the single IRB arrangement. Participating sites 
will provide necessary information, assurances or adverse events to the Duke study team for submission to 
the Duke IRB and the respective local IRB. The Duke IRB office will communicate directly with the Duke PI 
and study team, with regular meetings to go over IRB-related issues. When appropriate, the Duke IRB 
office will communicate directly with the relying sites’ Human Research Protection Program offices.
Relying site (UNC) will follow local procedures to coordinate, collect, verify, and locally distribute 
information
such as:
• Local context
• Conflict of Interest disclosure and management
• Completion of ancillary reviews
• Training and qualifications of study team (IRB, ethics)
• Continuing Review or Closure information
• Reportable Events
How will you ensure that management, data analysis, and data safety and monitoring systems are adequate, 
given the nature of the research involved?
The Duke Data Center (DDC) will work closely with the PIs and will oversee consistent application of 
scientific standards and methodological rigor for data collection, processing, entry, cleaning, and analytics. 
This will be accomplished by intensive training of all study staff, the development of well-defined study 
specific procedures (SSPs), and Manuals of Procedures (MOPs) with detailed instructions for procedures 
involved in data acquisition, processing, and upload to the REDCap platform. Fidelity to research 
procedures will be accomplished by the development of well-defined protocols and internal audits.
How will you ensure that sample protocols and informed consent documents are developed and distributed 
to each collaborating institution?
The Duke Site will:
Submit IRB application to sIRB. Distribute copies of IRB-approved documents to sites for editing and 
submission to local IRBs. Oversee and collect all required documentation and assurances (e.g., FWA to 
OHRP and reliance agreements) from sites for sIRB. Review and assist in site IRB applications for study as 
needed. Maintain records of IRB submissions, approvals, and expiration dates for all study sites. Provide 
guidance on IRB forms and track annual continuing reviews. Post IRB documents and regulator 

documentation to central website. Distribute approved protocol changes/amendments to sites and develop 
SOPs to assure updates are distributed and receive IRB approval prior to initiation of any changes.
How will you ensure that each collaborating institution holds an applicable OHRP-approved Assurance?
Ongoing current proof of Site-specific IRB Assurance will be collected (and updated as warranted) from 
each site, and maintained at Duke.
How will you ensure that each protocol is reviewed and approved by the IRB at the collaborating institution 
prior to the enrollment of subjects?
Ongoing current proof of Site-specific IRB approval will be collected (and updated as warranted) from each 
site, and maintained at Duke. These approvals will be uploaded as part of continuing review submissions to 
the Duke IRB.
How will you ensure that any substantive modification by the collaborating institution of sample consent 
information related to risks or alternative procedures is appropriately justified?
Collaborating institution (UNC) will provide all approved consent versions back to the Duke site, and any 
significant modifications from the Duke provided template will be shared with the Duke IRB to confirm 
appropriateness prior to use with subjects.
How will you ensure that informed consent is obtained from each subject in compliance with DHHS 
regulations?
Subject consent will occur either electronically, stored directly in REDCap, or when completed on paper, 
will be scanned and uploaded into REDCap to allow for coordinating site consent review QC activities.
 
Research Abstract
Please type your Research Abstract here:
The Research Abstract should summarize the main points of your study in one paragraph. The following 
guidelines may help you:
 
1. Purpose and objective (1-2 sentences)
2. Study activities and population group (2-4 sentences)
3. Data analysis and risk/safety issues (1-2 sentences)
The purpose of the study is to establish a clinical cohort for the Duke/UNC Alzheimer's Disease Research 
Center (ADRC). The cohort will be composed of subjects ages 25 to 44 at enrollment with normal cognition 
and subjects ages 45 to 80 at enrollment with normal cognition, mild cognitive impairment and a dementia 
diagnosis. Initial data including demographics, medical and family history, physical exam, 
neuropsychological testing will be obtained. Participants will most likely be asked to contribute a blood and 
urine sample, a cerebrospinal fluid sample, and undergo a MRI scan. The cohort ages 45 to 80 will be seen 
yearly until death to evaluate medical status, undergo neuropsychological testing and possibly collect 
additional samples or undergo additional imaging. All data will be de-identified and stored by the ADRC.
 
Research Summary
State your primary study objectives
The primary objective is to create a clinical cohort for the Duke/UNC ADRC, enrolling 100 subjects per year 
until recruitment goals are met; thereafter we will enroll new participants only to replenish the cohort 
following subject death, withdrawal or loss to follow-up.  The ages of the cohort will be 25 to 44 and 45 to 
80 at the time of enrollment. Subjects ages 45 to 80 must have a project partner as part of the study. The 
cohort will undergo baseline data collection according to the current guidelines of the Uniform Data Set, 
set forth by the National Alzheimer's Coordinating Center including medical and family history, 
socioeconomic demographics, physical exam, neuropsychological testing, blood and urine sample, 
cerebrospinal fluid sample, and brain MRI. A subject's project partner can be substituted for another one, 

and if so, the new potential project partner will be consented into the study. Subjects in the ages 45 to 80 
group will be re-evaluated every year with a medical history update, physical exam and neuropsychological 
testing.
Additional blood, fluid or imaging may be requested at later dates. As part of their enrollment in the cohort 
the subjects will be presented yearly to a consensus committee to confirm diagnosis. A subset of the 
cohort ages 45 to 80, unable or unwilling to have the Lumbar Puncture, may alternately be offered to 
supplement a PET Scan to confirm diagnosis if/when AD symptoms are present.
The Duke/UNC ADRC obtained funding from the National Institute of Aging (NIA) in September 2021 and is 
an NIA designated ADRC program.
 
 
State your secondary study objectives
n/a
Please select your research summary form:
Standard Research Summary Template
This is the regular (generic) research summary template which is required  for all regular applications (unless 
your protocol fits under the other research summary templates in this category).  Use of these instructions is 
helpful for ensuring that the research summary contains all necessary elements.
 
Standard Research Summary
Purpose of the Study
 
Objectives & hypotheses to be tested
The purpose of the study is to build a clinical cohort of adult research subjects with normal cognition, mild 
cognitive impairment (MCI) and dementia due to Alzheimer’s disease and other related dementias (ADRD). 
The primary objective of this cohort will be to advance research on neurodegenerative brain disorders and 
the role of age, sex and genetics (especially APOE genotype) on their manifestation.
Background & Significance
Should support the scientific aims of the research
Approximately 5 million Americans are currently suffering from Alzheimer’s disease and related dementias 
(ADRD) with twice that number affected by mild cognitive impairment.   Currently over $100 million per 
year is spent on direct and indirect costs of caring for people with ADRD. Unless effective interventions are 
found the numbers of people with ADRD will continue to increase as the population ages.
Alzheimer's Disease Research Centers have been in existence since 1984 when Congress directed the 
National Institutes of Health (NIH) and the National Institute on Aging (NIA) to increase research on 
dementia. Dementia research continues to be a national priority. In 2011 Congress passed the National 
Alzheimer’s Project Act with the primary goal of preventing and effectively treating ADRD by 2025. This act 
created increased funding opportunities for Alzheimer’s Disease Centers to increase advances in the field 
through research and resource generation and sharing. In 2017, strategic planning by the NIA resulted in 

recommendations including establishing new cohorts to build predictive models of disease and wellness 
and sharing of data, disease models and biological specimens for research purposes. Participants in a 
cohort should be well characterized with standardized clinical data collection and followed yearly until 
death.
As an NIA designated Alzheimer’s Disease Research Center, the Duke/UNC ADRC is establishing a clinical 
cohort of research participants ages 25 to 44 who have a one time set of visit and a clinical cohort of 
research participants ages 45 to 80 who have a baseline set of visits and are followed yearly. Both groups 
will contribute biological samples kept in the ADRC repository.
This project will establish a clinical cohort at Duke and UNC with standard clinical data gathering and 
biological samples that can be used for current and future research studies at Duke and in the future, as 
part of collaboration with other Alzheimer’s Disease Centers and national and international research 
projects including the National Central Repository for Alzheimer’s Disease and Related Dementias (NCRAD) 
and the National Institute on Aging Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS).
Design & Procedures
Describe the study, providing details regarding the study intervention (drug, device, physical 
procedures, manipulation of the subject or the subject’s environment, etc.). Discuss justifications for 
placebo control, discontinuation or delay of standard therapies, and washout periods if applicable. 
Identify procedures, tests and interventions performed exclusively for research purposes or more 
frequently than standard of care. Include alternative therapies, concurrent therapies discontinued per 
protocol, risk benefit ratio, and use of tissue/specimens. Discuss monitoring during washout periods if 
applicable. Include brief description of follow-up, if any.
Subjects with normal cognition, mild cognitive impairment and dementia diagnosis will be recruited from 
clinical visits at the Duke Neurology Memory Disorders Clinic at Morreene Road. Subjects will also be 
enrolled by self-referral and active recruitment through participation in existing studies, registries, 
educational talks at community organizations and community health fairs. Subjects in the ages 45-80 
cohort must have a dedicated project partner of their choice at time of enrollment. The project partner is 
an individual who knows the participant well, preferably a family member (e.g. spouse, adult child). 
Written informed consent will be obtained from all participants and their project partners (via paper or via 
eConsent). Besides answering questions about the participant, we are mandated to ask the project 
partners very basic demographic information about themselves. For example; race, ethnic background, 
gender, month & year of birth, years of education, relationship to participant, and type & frequency of 
contact with the participant. A potential subject screening log will be   securely maintained, including 
potential subject Name, Contact Info (Email and Preferred Phone Number), Age (aggregated 89+), Race, 
Zip Code, Sex, Years of Education, Referral Source, and reason for non-enrollment (when applicable). The 
maintaining of a basic screening log is to ensure that we do not contact people multiple times, and to 
ensure equitable recruitment of people among race and education levels (via aggregate analyses).
Subjects will have an initial visit with information/history gathering, physical exam, neuropsychological 
testing and blood draw. The project partner will be asked questions about the participant’s activities of 
daily living (ADL’s), mood, and day to day behaviors. Subjects will have follow up visits coordinating 
imaging, lumbar puncture and donation of other biological samples. Either Lorazepam (0.5 to 1mg) or 
Alprazolam (0.25 to 0.5mg) will be prescribed at the request of the participant to help mitigate anxiety 
during the MRI and/or lumbar puncture. Both medications are taken by mouth, and subject will be 
informed they must have a driver present if they decide to take this medication prior to either of these 
procedures. Subjects also have the option to undergo an MRI simulation that closely mimics a real MRI 
scanner in terms of appearance, sensation, and sound. It features an automated table, lights, and a fan to 
enhance the realism of the experience. Additionally, the simulator can display tasks and playback MRI 
sounds, ensuring subjects are well-prepared and comfortable for the actual MRI scan.
Subjects and project partners in the ages 45 to 80 cohort will have an annual follow up visit as long as 
they are able to participate, preferably in person, but may also occur over the telephone if necessary.
All information gathered at the initial visit and annual follow up will be entered into the the current version 
of the Uniform Data Set (UDS), a longitudinal data set that is submitted to the National Alzheimer’s 
Coordinating Center (NACC). At baseline and at yearly follow up, a consensus committee will meet to 
make a diagnosis based upon history and presentation, neuropsychological testing, imaging, and 
biomarker information.
All activities are research related. Subjects ages 25 to 44 and ages 45 to 80 will have a baseline visit which 
may contain tests including:

At Baseline Visits (typically over 3 visits, completed within 60 days of initial visit)
    Informed consent will be obtained from subject and project partner (if not otherwise already 
obtained remotely)
    Subjects will be assigned a coded research identification number used for the UDS and biological 
specimens in the repository
    Demographics and project partner demographics
    Family history, medical history and current medications
    General physical and neurological exam, including sensory and motor testing
    Vital signs
    Blood sample will be collected for genetic testing and distributed into aliquots, which will be 
stored at Duke for future unspecified research on cognition and disorders associated with altered 
cognition with blood processed and stored by Substrate Services. For females aged 45-60, 
additional 10ml blood draw for ReproSURE test, processed and frozen, then sent to LabCorp for 
testing.
    Urine sample
    Neuropsychological testing including
Montreal Cognitive Assessment (MoCA)
Clinical Dementia Rating (CDR)
Craft Story 21 Recall - Immediate
Benson Complex Figure Copy,
Number Span   
Test Forward,
Number Span Test Backward
Category Fluency
Trails A and B
Craft Story 21 Recall – Delay
Benson Complex Figure Recall
Multilingual Naming Test (MINT)
Verbal Fluency – Phonemic Test
Rey Auditory Verbal Learning Test (RAVLT)
Benton Judgement of Line Orientation (JoLO)
Virtual Reality Functional Capacity Test - short version (VRFCAT-SLx)
Note: To increase subject safety and reduce subject travel/time burden, portions of this visit may be 
conducted remotely via phone/video chat, particularly pertaining to the Uniform Data Set (UDS), version 3 
which includes demographics and project partner demographics, family history, medical history, current 
medications and neuropsychological testing. 
Retinal imaging (non-invasive screening of subject's eyes to look for potential signs of Alzheimer’s 
or related disorders)
Additional testing of subject's memory, thought processes and recognition, including the PHQ8 and 
GAD 7. We will also assess menopause status on appropriate female subjects using the Menopause 
Specific Quality of Life (MENQOL) questionnaire and the Stages of Reproductive Aging Workshop 
(STRAW) + 10 staging system (STRAW-10).
 MRI of the brain will be performed at Duke.
 (except when not applicable) LP will be performed in the Morreene Road Clinic as well as the ADRC 
offices in the Hock Plaza Building (2424 Erwin Road, Suite 103), by a neurologist or in the PACU or 
Medicine Pavillion by an anesthesiologist proficient in the task.  Subjects will be informed about the 
risk of Lumbar Puncture (LP) and a procedure consent signed.  The LP will be done using standard 
aseptic technique in a lower lumbar intervertebral interspace. No more than 15 ml's of CSF will be 
collected in vials containing a bar coded label indicating the subjects ADRC ID number, but no 
PHI.  Samples will be frozen on dry ice and transported to the Duke Substrate Services Core 
Research Support, for processing and storage. If the study doctors believe that a Blood Patch is 
necessary, this may be conducted by a study physician.
A member of the Duke ADRC team will call subjects 1-3 days after the LP to discuss their health 
and confirm any AEs.
Where applicable, PET scans will be obtained (in accordance with ADRC parameters) at either Duke 
or the UNC Biomedical Research Imaging Center (BRIC).  
Information gathering, neuropsychological testing, blood sample, and urine sample will be done at the 
Duke Neurology Outpatient Office at Morreene Road, as well as the ADRC offices in the Hock Plaza Building 
(2424 Erwin Road, Suite 103). Lumbar puncture will be conducted at these offices, but may also be 
conducted at the Duke North PACU at the discretion of the PI. MRI will be done at Duke Radiology.
Responses will be recorded as subjects respond to various cognitive testing questions. We will record the 
audio with a Sony digital voice recorder, or other secure audio recording device and software. Subjects will 
be told that their voice is being recorded and that no additional personally identifying information will be 
on the saved recording, beyond their voice alone.  All recordings will be given a unique identifier before 

they are uploaded to Duke Box. Once the upload is complete, all data will be deleted from the voice 
recorder.  No PHI will ever be stored on the digital voice recording device. The data will be used for testing 
scoring purposes, and may be shared for research purposes only if participants give their consent to do so, 
as indicated on their consent form.
Yearly evaluations
Subjects and project partners in the ages 45 to 80 cohort will be contacted approximately every 12 
months for a follow-up evaluation.   At the yearly follow up evaluation we will update medical information 
and perform neuropsychological testing. We may also collect additional blood or CSF and additional 
imaging. These follow-up evaluations are done ideally in person but also can be conducted over the 
telephone. Participants will be asked to participate in yearly evaluations until the time of death. 
Participants can withdraw from the study at any time without concern for the future of their care.
Engagement Activities
Participants will have the opportunity to attend occasional engagement events that may include updates 
on the study and Alzheimer's Disease research, as well as information on brain health and aging.
Consensus Committee Diagnosis
After data collection is completed, a consensus committee composed of representatives from neurology, 
neuropsychology and imaging will meet on a bi-weekly to monthly basis to review information on each 
subject and come to a consensus diagnosis. Each subject will be reviewed at baseline and yearly.
Storage of data
All data gathered as part of the UDS will be stored in Redcap on a secure server.
Storage of samples
Blood and CSF samples will be stored in a freezer at -80°C at the Duke Substrate Services (SSCRS) under 
the direction of the Duke ADRC. Substrate Services Core Research Support (SSCRS) serves as a 
centralized processing core and storehouse at Duke for research samples for large clinical, consortium-
based collaborations and for basic, discovery science. Samples will not contain any PHI and will be 
assigned a Repository ID number.  Study staff will maintain the link between the PHI and samples on a 
password protected server in the ADRC.
Samples are stored indefinitely or until samples are exhausted. Subjects can request to have their samples 
withdrawn by sending a written request to the PI.   
Research and Specimen Sharing
We will share subject's coded biological samples and data with the National Cell Repository for Alzheimer’s 
Disease and Related Dementias (NCRAD), a research facility at Indiana University that is supported by the 
National Institute on Aging to facilitate genetic research in Alzheimer disease, aging, and related disorders. 
All biological samples sent to NCRAD will also be stored indefinitely and processed at NCRAD for use by 
qualified scientists at other Alzheimer’s Disease Centers and other research centers (including other 
academic and commercial laboratories studying Alzheimer’s disease, aging, and other related disorders). 
In addition to the blood sample, some coded demographic information about the subject (age/year of 
birth, family history of dementia, and diagnosis) will be sent to NCRAD. Subject identity will not be shared 
with NCRAD or with any other outside investigators. Duke has an already established MTA with NCRAD. No 
data nor samples will be transferred, except while such an agreement is in effect.
Otherwise, all research data and specimens will be made available only to DUHS and UNC Faculty, DUHS 
and UNC study coordinators, and external investigators that can provide proof of current IRB approval and 
that have also submitted a proposal to the Principal Investigator, Dr. Heather Whitson. Investigators 
wishing to gain access to these data and/or samples will be required to submit a separate IRB application 
and consent (or proof of waiver) for this purpose. All proposals must be internally reviewed to assure 
appropriate use of the data/specimens and to determine feasibility and availability of resources.  All 
requests and approvals for usage are tracked internally.  We also request copies of any publications from 
all investigators that resulted from, or included, data/specimens from our database/repository.
It must be emphasized that all data/specimens released from the Duke/UNC ADRC database/repository are 
de-identified (unless granted specific subject approval to also include potentially identifiable data
/specimens such as audio recordings, DNA, and retinal images).  All data/specimens are coded by a unique 
Duke/UNC ADRC ID number rather than by name.  Data and specimen information are maintained in the 
database according to identifier number and not by name.  All original (primary) data are stored in locked 
cabinets in a locked room or on a Duke IT secure server which is  password protected and backed up 
regularly.   Project staff strictly protects access.  No specimens/data are ever released to third outside 
parties unless the subject (or the participant’s legal representative) has requested and consented to data 
release (e.g. for medical purposes).  A strict confidentiality policy is in place for all project staff.  Access to 

the data is restricted and protected as required by law and can only be accessed by authorized 
investigators and research staff. For information disclosed outside of Duke University Health System and
/or UNC Health System, it will be assigned a unique Duke/UNC ADRC code number.  The key to the code 
will be kept in a secured file on the database server and the Data Management team leader will keep a 
secure back-up copy.
The database/repository will be maintained indefinitely as long as funding is available or until the data
/specimens are exhausted.
PET Sub-study 
A subset of the total ages 45 to 80 cohort (up to 100 total subjects), unable or unwilling to have the 
Lumbar Puncture, may alternately be offered to supplement a PET Scan. This subset will sign a main 
consent (LP or non-LP) as well as a specific PET consent at the time of their scan. Some PET Scans will 
occur at the UNC Biomedical Research Imaging Center (BRIC) facility, with imaging and data shared with 
the Duke site in accordance with executed data agreements.
We will presently administer the Amyloid and Tau ligands to all subjects receiving PET, unless otherwise 
indicated. If 2 PET scans are to occur on the same day, this will be conducted in accordance with standard 
safety procedures at the BRIC regarding wash-out period. 
At present, UNC is seeking an IND for the approved ligands. Until those INDs have been received, we have 
a cap of 30 subjects per ligand. Once IND is received, it will be submitted to the UNC RDRC and the Duke 
IRB alog with request to lift that cap of 30 subjects.
Duke/UNC ADRC Collaboration
As the federal grant has come through supporting the Duke/UNC ADRC, there will be elements of subject 
and data sharing between the institutions that are presently being contractually developed. This sharing 
will not commence until all related agreements have been fully executed, and this IRB application (and the 
RDSP) will be updated accordingly at that time to describe the specifics.
Per Subaward Attachment 7: "This project/protocol is part of a Joint Federally Grant-funded Duke/UNC 
Alzheimer's Disease Research Center (ADRC) and the clinical cohort protocol (Pro00103958) will be multi-
site with Duke as the IRB of Record. Along with the general sharing of study data between the sites, there 
will also be coordination of subject visits between the sites requiring contact information sharing. Also, PET 
scans for all subjects will be taking place at UNC so transfer of any PET data and images back to Duke will 
need to be permitted. We expect to utilize the same transfer method currently used between the UNC 
Biomedical Research Imaging Center (BRIC) and the Duke Brain Imaging and Analysis Center (BIAC). Data 
sharing will be primarily via shared access to REDCap (with Data Access Groups used to minimize 
unnecessary sharing, where appropriate), and otherwise via Duke Box.
Data elements will include but is not limited to name, contact information, MRN's, and dates."
iMIND study (Pro00111831)
For subjects enrolled via consent into both this protocol as well as the iMIND study (Pro00111831), clinical 
consensus, apoe, and biomarker data will be shared with appropriate KP on the iMIND study, via REDCap 
and Locker Room access.
UDSv4 Sub-Study
From May 2024 to July 2024, a subset of active subjects (up to 5 subjects) may complete an additional 
visit in order to pilot the updated UDS (version 4).  Active participants and their study partners that have 
completed a study visit with cognitive testing between March 2024 and July 2024 will be recruited to 
complete an additional visit within 3 months.  Subjects will return to the Hock Plaza building for the UDS 
version 4 (UDSv4) and will be asked to provide feedback about the visit.  Data will be entered into a 
separate project in REDCap and will be submitted to NACC.  Portions of this visit may be conducted 
remotely via phone/video chat.
Selection of Subjects
 
List inclusion/exclusion criteria and how subjects will be identified.
Inclusion Criteria for All Subjects

Each subject must be ≥ 25 to ≤ 80 years of age.
Each subject must be able to read at a 6th grade level, as determined by the investigator, and 
must have a history of academic achievement and/or employment sufficient to exclude significant 
intellectual disability.
Each subject (or legal representative) must sign the informed consent form after the scope and 
nature of the investigation have been explained to them, and before screening assessments. Some 
consent may be obtained via phone script and REDCap eConsent.
Each participant must be willing to have an MRI and a lumbar puncture, or alternately (to the 
lumbar puncture) a series of PET scans.
Each participant ages 45 to 80 must have a study partner who agrees to participate in the study 
and who is able to read at a 6th grade level, as determined by the investigator, and must have a 
history of academic achievement and/or employment sufficient to exclude intellectual disability.
 Exclusion Criteria
Evidence of a clinically relevant or unstable neurological disorder including history of multiple head 
injuries, stroke or other CNS conditions (MS, Parkinson's disease, etc.) 
Evidence of a clinically relevant or unstable psychiatric disorder. 
Impairment that cannot be accommodated to be able to complete a valid Neuropsychological 
assessment. (vision or hearing impairment, eg.)
History of alcoholism or drug dependency/abuse within the last 2 years before enrollment. 
Potential subjects are given PHQ8/GAD7 questionnaires as screening.  For those that screen fail, 
their questionnaire results will be kept in RedCap and we are keeping this information to track 
reasons for screen failure. This information will be stored for study team use only and will not be 
shared outside of the Duke/UNC Collaborative ADRC. For those that pass the screening, the 
information from the questionnaires will be used in the study. Those with a GAD-7 score >9 and/or 
PHQ-8 score >9 will be considered ineligible. 
An ongoing uncontrolled, clinically significant medical condition such that, in the judgment of the 
investigator, a subject's participation in the trial would pose a significant medical risk to the 
subject. 
Contraindication or intolerance to 3T MRI investigations, including implanted devices 
Inability to have an MRI.
Unwillingness to consent to data sharing between Duke and UNC.
History of malignancy of any organ system, treated or untreated, within the past 24 months, 
regardless of whether there is evidence of local recurrence or metastases. However localized 
tumors not requiring systemic chemo- or radiotherapy, localized basal or squamous cell carcinoma 
of the skin, or in-situ cervical cancer are permitted. 
If CSF sampling is scheduled for this participant: Contraindication to lumbar puncture, history of 
back surgery (with the exception of microdiscectomy or laminectomy over one level), signs or 
symptoms of intracranial pressure, spinal deformities or other spinal conditions that in the 
judgment of the investigator would preclude a lumbar puncture; treatment with antiplatelet 
medication at the time of enrollment, including but not limited to Plavix; chronic treatment with 
anticoagulant medications including but not limited to Coumadin and direct oral anticoagulant drugs 
such as Eliquis and Xarelto.
Subject Recruitment and Compensation
Describe recruitment procedures, including what method(s) will be used, when the study will be 
introduced to potential participants and by whom.  If any follow-up contact is planned, describe the 
proposed method and timing. Describe how you will ensure that subject selection is equitable and all 
relevant demographic groups have access to study participation (per 45 CFR 46.111(a) (3)). Include 
information about how many DUHS participants will be recruited. If participants are to be compensated 
and/or reimbursed, provide specific prorated amounts to be provided for expenses such as travel and
/or lost wages, and/or for inducement to participate.
Subjects will be recruited from the Alzheimer’s Disease Prevention Registry, Genematch Registry, the 
North Carolina Registry for Brain Health and advertisements in social media and news platforms. Affiliates 
of the Duke/UNC ADRC will also speak about the study at community education events and health fairs. An 
outreach coordinator will assist with recruitment of individuals from diverse racial and socioeconomic 
groups.
Subjects with mild cognitive impairment or dementia (or eligible family members) will be recruited from 
the Memory Disorder Clinic held at the Morreene Road Clinic. A caregiver known to the patient and/or 
legally authorized representative (LAR) will introduce the study to subjects with dementia and the research 
team will only approach patients that express interest in participation. Participants will also be recruited 

from UNC Memory Clinics with a flyer and the study introduced by their provider. Subjects recruited from 
UNC Memory clinics will be enrolled as Duke/UNC ADRC participants.
A goal is to recruit 100 subjects per year. Over the life of the current Federal grant, the anticipated 
recruitment numbers for the 45-80 cohort is projected to be 420 participants and they must have a project 
partner - so 420 project partners.
The 25-44 cohort is projected to be 120 participants. Altogether the maximum expected enrollment over 
this period is 960.
Subjects will receive:
$50 upon completion of UDS4, blood draw
$50 upon completion of each annual (yearly) follow up  
$100 upon completion of MRI
$100 upon completion of each PET scan
$100 upon completion of lumbar puncture
 They will be paid by ClinCard.
UDSv4 Sub-Study
Active subjects that completed a study visit between March 2024 and July 2024 will be asked to return for 
an additional visit within 3 months.  Up to 5 subjects will be enrolled in the study including at least 1 
subjects with dementia, 1 subject with mild cognitive impairment and 1 subject with normal cognition.
Subjects will receive $50 upon completion of UDSv4 via ClinCard.
Consent Process
 
Complete the consent section in the iRIS Submission Form.
Subject’s Capacity to Give Legally Effective Consent
If subjects who do not have the capacity to give legally effective consent are included, describe how 
diminished capacity will be assessed. Will a periodic reassessment occur? If so, when? Will the subject 
be consented if the decisional capacity improves?
Subjects with a diagnosis of dementia will be required to have informed consent signed by an LAR. 
Competency to sign consent will be addressed by the PI or treating physician for subjects with mild 
cognitive impairment. Periodic reassessment of competency will be assessed at the yearly evaluation 
based upon by history and cognitive testing. Dementia is a progressive disorder with no chance of 
improvement so there is no chance of improvement in decisional capacity.
Study Interventions
If not already presented in the Design & Procedures section, describe study-related treatment or use of 
an investigational drug or biologic (with dosages), or device, or use of another form of intervention (i.
e., either physical procedures or manipulation of the subject or the subject’s environment) for research 
purposes.
There are no study interventions involved in this research.
Risk/Benefit Assessment

Include a thorough description of how risks and discomforts will be minimized (per 45 CFR 46.111(a) (1 
and 2)). Consider physical, psychological, legal, economic and social risks as applicable. If vulnerable 
populations are to be included (such as children, pregnant individuals, imprisoned persons or 
cognitively impaired adults), what special precautions will be used to minimize risks to these subjects? 
Also identify what available alternatives the person has if he/she chooses not to participate in the 
study. Describe the possible benefits to the subject. What is the importance of the knowledge expected 
to result from the research?
The risks to subjects in this study are related to the lumbar puncture (risk of fainting, bleeding, bruising, 
headache and infection), phlebotomy (fainting, bruising and infection), sensory and motor testing (muscle 
strain, dizziness, falls), MRI (risk of claustrophobia), PET Scan (risk of claustrophobia and radiation 
exposure), and loss of privacy. 
Regarding PET Scan, 2 radioactive tracers are to be used, 11c-PiB, and 18F-MK-6240, manufactured by 
the UNC/BRIC Radiopharmaceutical Facility in accordance with cGMP standards, and under the requisite 
INDs and approval by the UNC Radioactive Drug Research Committee (RDRC).
The procedures will be explained in detail to the subjects and performed using aseptic technique by 
experienced clinicians.  Particular care will be taken to explain the procedures to subjects with dementia to 
allay fear and assure that the subject assents to participation. Project partners will be present with 
patients with dementia to provide comfort, support and explain procedures.
Privacy will be protected by identifying subjects only through an assigned ID number. The code linking PHI 
and UDS, repository specimens and imaging will be stored on a password protected server in the 
Alzheimer Disease Research Center at Duke.
There is no direct benefit to subjects from participating in this study.  There is the potential for indirect 
benefit from advancing knowledge about dementia.  Dementia is one of the most common causes of death 
and no disease-modifying therapies are available, so the potential benefit is great.
 
Costs to the Subject
Describe and justify any costs that the subject will incur as a result of participation; ordinarily, subjects 
should not be expected to pay for research without receiving direct benefit.
There is no cost to the subject for participation in the study.
Data Management, Analysis and Statistical Considerations
Describe endpoints and power calculations. Provide a detailed description of how study data will be 
analyzed, including statistical methods used, and how ineligible subjects will be handled and which 
subjects will be included for analysis. Include planned sample size justification. Provide estimated time 
to target accrual and accrual rate. Describe interim analysis including plans to stop accrual during 
monitoring. Phase I studies, include dose escalation schema and criteria for dose escalation with 
definition of MTD and DLT.  
For external collaborators/personnel who are 
 in the research but are handling de-
NOT ENGAGED
identified or a limited data set of 
 data, include their name, role and a description of the data.
Duke
A consensus committee will meet bi-weekly to monthly to review the clinical data gathered through the 
Uniform Data Set, imaging, and laboratory testing to determine a baseline consensus diagnosis for each 
subject enrolled in the cohort. Updated data on each subject will be reviewed yearly by the committee with 
an updated consensus diagnosis. Otherwise, there is no data analysis as part of the clinical cohort.
The goal is to enroll 100 subjects per year in the cohort, until recruitment goals are met. Thereafter, new 
participants will be recruited only to replenish the cohort due to death, withdrawal, or drop-out.  Subjects 

will otherwise participate in the clinical cohort until the time of death, withdrawal or drop-out. The purpose 
of this cohort and its collected data and samples is to serve as a resource for future study. There is no end 
point for the study.
Data & Safety Monitoring
Summarize safety concerns, and describe the methods to monitor research subjects and their data to 
ensure their safety, including who will monitor the data, and the frequency of such monitoring. If a 
data monitoring committee will be used, describe its operation, including stopping rules and frequency 
of review, and if it is independent of the sponsor (per 45 CFR 46.111(a) (6)).
This protocol does not involve treatment of subjects.  Lumbar puncture and phlebotomy are procedures 
that are done routinely in clinic. Although lumbar punctures are routinely performed in the clinic, they are 
considered greater-than-minimal risk procedures.   MRI has no associated risks if subjects are screened for 
metal and other devices before the scan. Adverse events will be documented and reviewed by the 
PI.  Further, the PI will report adverse events and problems to the IRB in accordance with institutional and 
HRPP policies.  
The Clinical Research Unit (CRU) Quality Assurance coordinator will review the study annually for 
regulatory compliance and data quality.
Privacy, Data Storage & Confidentiality
 
Complete the Privacy and Confidentiality section of the iRIS submission form.
 
Study Scope
Does this study have a cancer focus?  Cancer focus includes studies that enroll >50% oncology or malignant 
hematology patients; or, preventing, detecting, and diagnosing cancer or understanding the impact of 
cancer on patients and their caretakers.
  Yes   
  No
Does this study involve the use of a drug, biologic, food, or dietary supplement?
 Yes   
 No
Does this study involve the use of a medical device, an algorithm (whether computer based or not), an in 
vitro diagnostic test, or samples to look for biomarkers?
  Yes   
  No
Does this study employ magnetic resonance, including imaging (MRI), spectroscopy (MRS), angiography 
(MRA) or elastography (MRE) beyond the standard of care?
 Yes   
 No
Does this study specify or require the performance of diagnostic procedures using ionizing radiation (x-rays, 
DEXA, CT scans, nuclear medicine scans, etc.) that are beyond the standard of care?

 Yes   
 No
Does this study specify or require the performance of therapeutic procedures using ionizing radiation 
(accelerator, brachytherapy or systemic radionuclide therapy) that are beyond the standard of care?
  Yes   
  No
Does this study specify or require the use of a laser system for diagnosis or therapy that is beyond the 
standard of care (excludes the use of lasers as a standard surgical instrument)?
  Yes   
  No
Will the participant be subjected to increased or decreased ambient pressure?
  Yes   
  No
Do you plan to recruit subjects from Duke Regional Hospital (DRH)?
  Yes   
  No
Do you plan to recruit participants from Duke Raleigh Hospital or any Wake County Clinic(s) that are 
governed by Duke Raleigh Hospital (e.g. Duke Cancer Centers located in Wake County)?
  Yes   
  No
Does this study include using the Duke logo in any advertisements?
 Yes   
 No
Is this study retrospective, prospective, or both?
"Retrospective" means that data or samples already in existence (collected prior to the study submission) will 
be used.
"Prospective" means there will be data or samples collected in this study for research purposes.
Retrospective 
Prospective 
Retrospective and Prospective 
If the study is both retrospective and prospective: Is this a review solely of information collected for non-
research purposes (i.e. a review of medical records)?
  Yes   
  No
Does this protocol include any research using botulinum toxin, including the FDA-approved clinical product 
(Botox)?
  Yes   
  No
Does this protocol involve the administration of any of the following materials to humans?
Category of Investigational Product
Examples

Any mRNA
Pfizer or Moderna COVID-19 vaccines
Any viral vector
AAV vector, adenoviral vector (e.g., J&J or 
Astrazeneca COVID-19 vaccine)
Any genetically-modified cells
CAR-T cells (e.g., Kymriah, or other autologous 
cells)
Any genetically-modified organisms (virus, 
bacterium, or other agents)
Oncolytic viruses (Imlygic, others), certain live 
attenuated vaccines, challenge viruses or 
challenge bacteria
Any plasmid DNA
DNA vaccines
Any other recombinant or synthetic nucleic acid 
(DNA, RNA, others)
  Yes   
  No
 
Subject Population Groups and Enrollment
Population Groups (Select 
 population groups only):
targeted
Adults
Minors who are Wards of State
Minors
Duke Patients
Pregnant individuals
Fetuses
Imprisoned Persons
Adults incapable of giving consent
Adults with diminished capacity
Disabled subjects
Students
Employees
Healthy Controls
Deceased subjects
Blanket Protocol
Please select any population groups excluded from participation in this study:
Pregnant individuals
Will you administer a pregnancy test to eligible female subjects prior to the start of study activities?
 Yes   
 No
Maximum number of subjects to be consented at Duke:    

Enter a single number. If you anticipate consenting a range of subjects, enter the 
 limit of the range. 
upper
The number should represent the maximum number of subjects for the life of the study.
960
Maximum number of subjects to be consented at all sites:
Enter a single number. If you anticipate consenting a range of subjects, enter the 
 limit of the range. 
upper
The number should represent the maximum number of subjects for the life of the study.
960
 
Subject Procedures and Costs
Biobank - Does this study involve the collection, use, tracking, banking (storage) or distribution of human 
biological specimens?
Human biological specimens include blood or its components, healthy or diseased tissue, bodily fluids, DNA
/RNA or human stem cells.
 Yes   
 No
Procedures
Check all that apply:
Genetic Testing
Gene Transfer
DNA Banking
Testing for Reportable Infectious Diseases
Human Cell Banking
*Use of Human Embryonic Stem Cells
*Use of Human-induced Pluripotent Stem Cells
*Use of Other Cells Derived from Human Embryos
*Use of Human/Animal Chimeric Cells
*Specialized Cell Populations for Cell Therapy
Use of Human Tissue
Use of Bodily Fluids
Use of Blood (or its components)
Not Applicable
Will blood be drawn in this study for research purposes?
 Yes   
 No
Maximum amount to be drawn in any 8 week period (ml):
70
Number of blood draws per week:  
0
Will the Operating Room be used in this study?
Include only research time, not clinical care time.
  Yes   
  No

Will there be extra costs to subjects or insurance as a result of the research (e.g. tests, hospitalization)?
  Yes   
  No
Will there be Subject Compensation?
 Yes   
 No
Compensation for Travel / Lost Income (in USD):
0
Other Subject Compensation:
Subject partner will be paid $50 (each) for each completed visit The subject will receive:
• $50 upon completion of Visit 1 
• $50 upon completion of each annual (yearly) follow-up 
• $100 upon completion of Visit 2 
• $100 upon completion of Visit 3
UDSv4 Sub-Study: $50 upon completion of visit
Additional travel (mileage) compensation may be provided for distances of greater than 15 miles each 
way. We can provide reimbursement up to $250 for round-trip mileage from your home to each study 
visit at the current IRS rate. In the unlikely situation that an overnight stay near the research site is 
needed, we will provide accommodation at a local hotel and will reimburse meal expenses up to the 
Federal per diem rate, with receipts.
Subjects may additionally be provided:
1) up to $30 reimbursement ($15/person, $30 total if subject and caregiver), per visit, to aid with costs 
for meals during on-site visits.
2) a gift Totebag (value, less than $5 each) to each subject, to aid in confidential carrying of study related 
materials.
 
Subject Recruitment Materials
For each document to be reviewed, use the table below to provide the following information:
Attach a copy of each advertisement to be used with this study in the Initial Submission Packet. 
If any advertisement will have multiple wording variations, attach a copy of each version of the 
advertisement.  For media materials (i.e., videos, radio ads, commercials), include transcripts and 
links.  
If an advertisement includes the Duke logo, be sure to indicate “yes” in Study Scope section.
The IRB must approve all study advertisements used to recruit.
Types of subject recruitment materials include, but are not limited to, the following:
Direct Advertising
Posters
Billboards
Flyers
Brochures
Media Advertising
Newspaper Ads
Magazine Ads

Radio Ads
TV commericals / Video
Internet website
Social Media
Other Types of Advertising
Newsletter
Email
Postcards / Letters
(Note: Doctor-to-Doctor letters do not require IRB approval)
Document name
Material category
Location material 
displayed
Has this material 
previously been 
approved by the IRB?
ADRC Flyer 1
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
For use in the Duke 
and UNC memory 
clinics, to recruit 
participants
  Yes   
  No
ADRC Flyer 2
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
For use in the Duke 
and UNC memory 
clinics, to recruit 
participants
  Yes   
  No
ADRC Flyer - 
Multicultural
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
For use in the Duke 
and UNC memory 
clinics, to recruit 
participants. May 
also be posted in 
Social Media.
  Yes   
  No

ADRC Flyer - Black 
Family
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
For use in the Duke 
and UNC memory 
clinics, to recruit 
participants. May 
also be posted in 
Social Media.
  Yes   
  No
ADRC Flyer - 
Hispanic Family
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
For use in the Duke 
and UNC memory 
clinics, to recruit 
participants. May 
also be posted in 
Social Media.
  Yes   
  No
ADRC Flyer - White 
Family
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
For use in the Duke 
and UNC memory 
clinics, to recruit 
participants.
May also be posted 
in Social Media.
  Yes   
  No
Dr. Liu Message
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Video can be access 
by this link: 
  Yes   
  No

Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
https://duke.box.
com/s
/endgc5gsgxkk8uj7te
rfveuezzjiqhny
Will be shown to or 
shared with 
prospective study 
subjects.
MH Interview
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Video can be access 
by this link: 
https://duke.box.
com/s
/l0e427zx1qo0pw1qd
dvo1briop6gwlp6
Will be shown to or 
shared with 
prospective study 
subjects.
  Yes   
  No
Genematch Member 
Letter
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Genematch will send 
a personal email to 
each potential 
participant
  Yes   
  No
Results Brochure
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Provided to each 
participant during 
their results meeting 
in person or via zoom
  Yes   
  No
Billboard / Flyer / 
Poster 
Brochure 
Please be specific. For 
example, "Duke" 

APOE Results slide 
presentation
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
For use when 
providing APOE 
results to subjects
  Yes   
  No
MRI Disc label
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
On any MRI discs 
provided to subjects, 
there will be a 
warning label that 
"this MRI was done 
as part of a research 
study. The MRI 
images are research 
quality. Results 
should not be used 
for clinical purposes."
  Yes   
  No
DukeUNC 
Alzheimer's Disease 
Collaboration Flyers 
- Doc1
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Collection of flyers 
for use in 
community. 
Previously approved 
for use under 
another ADRC 
protocol.
 Yes   
 No
DukeUNC 
Alzheimer's Disease 
Collaboration Flyers 
- Doc2
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Collection of flyers 
 Yes   
 No

Newsletter / 
Newspaper / 
Magazine 
Other 
for use in 
community. 
Previously approved 
for use under 
another ADRC 
protocol.
DukeUNC 
Alzheimer's Disease 
Collaboration Flyers 
- Doc3
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Collection of flyers 
for use in 
community. 
Previously approved 
for use under 
another ADRC 
protocol.
 Yes   
 No
DukeUNC 
Alzheimer's Disease 
Collaboration Flyers 
- Doc4
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Collection of flyers 
for use in 
community. 
Previously approved 
for use under 
another ADRC 
protocol.
 Yes   
 No
DukeUNC 
Alzheimer's Disease 
Collaboration Flyers 
- Doc5
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Collection of flyers 
for use in 
community. 
Previously approved 
for use under 
another ADRC 
protocol.
 Yes   
 No
Billboard / Flyer / 

Hard to Reach letter
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Letter to be sent to 
subjects who have 
been difficult to 
reach.
 Yes   
 No
MRI Scan Prep video
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Shown to 
participants, pre-
MRI. Video can be 
accessed by this 
link: https://www.
ypo.education
/medical-tests/mri-
t257/video/
  Yes   
  No
ADRC First Year 
Visits letter
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Provided to 
participants during 
pre-screening to 
help understand 
Year 1 participant 
expectations.
  Yes   
  No
ADRC First Year 
Visits NON LP letter
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Provided to 
  Yes   
  No

Newsletter / 
Newspaper / 
Magazine 
Other 
participants during 
pre-screening to 
help understand 
Year 1 participant 
expectations.
Incidental MRI 
findings - Letter to 
participant
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Letter to provide to 
participant when 
neuro-radiologist 
finds a concerning 
finding on participant’
s MRI scan. Letter is 
sent after clinician 
contacts participant 
about finding.
  Yes   
  No
Incidental MRI 
findings - Letter to 
Medical Provider
Billboard / Flyer / 
Poster 
Brochure 
Internet website 
/ Email 
Letter / Postcard 
Phonescript 
Radio 
Television / Video 
Newsletter / 
Newspaper / 
Magazine 
Other 
Please be specific. For 
example, "Duke" 
would not be an 
appropriate location. 
"Duke Hospital 
Television" would be 
an appropriate 
response.
Letters to provide to 
participant’s medical 
provider when neuro-
radiologist finds a 
concerning finding 
on participant’s MRI 
scan. Letter is sent 
after clinician 
contacts participant 
about finding.
  Yes   
  No
 
Consent Process
Attach draft consent forms in the Initial Review Submission Packet.
Consent forms must be MS Word documents and follow the specific format outlined by the IRB. 
 to 
Click here
download a copy of the consent form template.
 Please do not edit the section of the footer that contains the Protocol ID, Continuing Review 
Note:
and Reference Date fields. Those fields will be used to stamp the final consent form when it is approved by the 
IRB. If you want to add an internal version date, please put it in the header.
Who will conduct the consent process with prospective participants? 

Provide their role(s) in this study (PI, Study Coordinator, etc.):
Designated key personnel will consent subject and the subject partner. This consent may either occur in 
person, or via phone (or approved, non-recorded method of video-call) utilizing a script as well as REDCap 
eConsent. Script will ask patients if sending them consent via email for discussion purposes is acceptable, 
prior to doing so.
Who will provide consent or permission?
(Select all that apply):
Participant
Parent(s) or Legal Guardian(s)
Legally Authorized Representative (LAR)
How much time will the prospective participant (or legally authorized representative) have between being 
 
approached about participating in the study and needing to decide whether or not to participate?  
If you are not giving the person overnight to consider whether or not to participate, please justify.
As much time as needed will be given for potential subjects and their study partner to decide about study 
participation.
Where will the consent process occur?
The in-person consent process will occur in the Duke Neurology clinics or at the ADRC offices in the Hock 
Plaza Building (2424 Erwin Road, Suite 103). 
Alternately, it may occur via phone/video utilizing the Screening/Consent script, as well as REDCap 
eConsent. Potential Subjects (and Caregivers) will be sent an email containing a link to REDCap, allowing 
them to create individual credentials, then read through the consent online while it is being discussed with 
them. Finally, the subjects/caregivers will be able to sign their consents electronically. 
Finally, if potential subjects contacted by phone do not have email/internet access, consent could be 
mailed to them prior to review by phone, then signed consent could be returned at Visit 1.
Regarding subject re-consent related to the data sharing between Duke and UNC, it will be specifically 
sought during a given subject's next research/clinic visit, if not sooner.
What steps will be taken in that location to protect the privacy of the prospective participant?
Any potential subject and their study partner will be taken to a private setting to discuss participation in 
the research.
How much time will be allocated for conducting the initial consent discussion, including presenting the 
information in the consent document and answering questions, with each prospective participant?
At least 1 hour will be designated for the consent process. However, if subject or subject partner have 
additional questions time will be made to address questions or concerns. Subjects and their study partners 
will also be given instructions regarding who to contact if they have additional questions after the consent 
process.
What arrangements will be in place for answering participant questions before and after the consent is 
signed?

Subjects and their study partners will also be given instructions regarding who to contact if they have 
additional questions after the consent process.
Describe the steps taken to minimize the possibility of coercion or undue influence.
Subjects and their study partners will be given as much time as needed to decide whether they wish to 
participate in the research.  They will also be reminded that their participation is voluntary and that they 
may withdraw at any time.  Because of the potential for diminished cognitive capacity in this population, 
enrolled subjects will be evaluated yearly for decision making capacity and will be asked to give assent if 
appropriate and necessary. 
What provisions will be in place to obtain consent from participants who do not read, are blind or who do not 
read/understand English?
Currently, there are no plans to obtain consent from participants who do not read, are blind or who do not read
/understand English.
Do you plan to obtain written consent for the conduct of research?
 Yes   
 No
 
Protected Health Information (PHI)
Indicate how you intend to use potential subjects' Protected Health Information (PHI):
I will review, but not record, PHI prior to consent. 
I will record PHI prior to consent. 
I do not intend to use PHI prior to consent. 
I will record PHI without consent. (decedent research, database repository, chart review) 
 
Request for Waiver or Alteration of Consent and/or HIPAA Authorization
Will the population include deceased individuals?
 Yes   
 No
This waiver request applies to the following research activity or activities:
Scheduling of research activities in MaestroCare and/or the recording of PHI via telephone for 
screening purposes prior to obtaining written consent for the research. Scheduling of research 
activities in MaestroCare and/or the recording of PHI via telephone for screening purposes prior to 
obtaining written consent for the research.
Ascertainment (identification, selection) and/or recruitment of potential subjects while recording 
identifiable private information, such as protected health information (PHI), prior to obtaining the 
subject’s consent.
Conduct of the research project without obtaining verbal or written consent and authorization.
Note: Answer the questions below as they pertain solely to PHI collected prior to consent.
Provide the following information:
List the elements of informed consent and/or HIPAA authorization for which waiver or alteration 
is requested:
Provide the rationale for each.

We are requesting a waiver of all elements of consent and HIPAA.   Subjects will be recruited from the 
Alzheimer’s Disease Prevention Registry, the North Carolina Registry for Brain Health and other registries, 
as well as from the Duke and UNC  Neurology and primary care clinics.  Subjects have given prior consent 
to be part of these registries. The project partner will not be recruited, as this will be someone familiar to 
the potential subject.
List the specific protected health information (PHI) to be collected and its source(s):
(Note: PHI = health information + identifiers)
Name, age, sex, pertinent health information and past medical evaluations related to cognition will be 
collected from potential research subjects or their legally authorized representative. A screening log will be 
securely and separately maintained from the enrollment log and subject database, including potential 
subject Name, 
Age (aggregated 89+), Race, Zip Code, 
Contact Info (Email and Preferred Phone Number), 
Sex, Years of Education, Referral Source, and reason for non-enrollment (when applicable). Contact info is 
included here to keep this information centralized and secure, yet remotely accessible to study staff so 
that they do not need to keep contact information in less secure locations. Access to this screening log will 
be limited to study team members with appropriate REDCap access rights.
Criteria for Waiver: The DUHS IRB may waive the requirement for informed consent and authorization if all 
of the following criteria are met:
Please respond to each item in the space below using protocol-specific language to provide justification:
a) The research or clinical investigation involves no more than minimal risk to subjects:
The information will be gathered by Duke/UNC ADRC research staff in a secure location and will only be 
shared with investigators. There is no more than minimal risk to subjects to identify potential subjects for 
this research.
b) The waiver or alteration will not adversely affect the rights and welfare of the 
subjects.  Include a description of any measures to be taken to ensure that the rights and welfare 
of subjects will be protected:
This waiver will not adversely affect the rights or welfare of potential subjects.  All efforts will be made to 
protect subject confidentiality as we use this waiver to ascertain potential subjects.
c) Whenever appropriate, the subjects will be provided with additional pertinent information 
after participation:
There will be no information to report to subjects, as this is a registry.
d) If this research activity relates to research involving deception, explain how subjects will be 
provided with additional pertinent information after study participation and what information will 
be provided. Otherwise indicate “not applicable”:
Not applicable.
e) The use or disclosure of protected health information involves no more than minimal risk to 
the privacy of individuals, based on, at least, the presence of the following elements (e1. and e2.)
 
Demonstrate that the use or disclosure of PHI involves no more than minimal risk to the privacy 
of subjects by describing the plans requested below:
e1) An adequate plan to protect the identifiers from improper use and disclosure.
Describe the plan (how protection will be accomplished) and indicate where the PHI will be 
stored and who will have access:       
Only Duke/UNC ADRC staff will record or have access to PHI through EPIC, Duke REDCap, or through 
phone calls. Whenever possible we will use the minimum necessary PHI to ascertain potential subjects. 
Any PHI will be stored on a secure shared drive maintained by Duke IT and the Duke/UNC ADRC, or in 
Duke REDCap. Subject consents will be either uploaded into REDCap, or entered there directly via 
eConsent.

e2) An adequate plan to destroy the identifiers at the earliest opportunity consistent with 
conduct of the research, unless there is a health or research justification for retaining the 
identifiers or such retention is otherwise required by law.
 
Describe the plan (how and when identifiers will be destroyed and by whom). If there is a health 
or research justification for retaining the identifiers or such retention is otherwise required by 
law, provide the reason to retain identifiers:
Subject identifiers used for identification and ascertainment of subjects will be destroyed at the earliest 
possible date, consistent with the conduct of the research.  This will be done by designated member(s) of 
the study team.  A screening log will be securely maintained, including potential subject Name, Contact 
 Age (aggregated 89+), Race, Zip Code, Sex, Years of 
Info (Email and Preferred Phone Number),
Education, Referral Source, and reason for non-enrollment (when applicable). As it is being maintained to 
ensure that we do not contact people multiple times and to ensure equitable recruitment of people among 
race and education levels (via aggregate analyses), this log will be destroyed at the conclusion of subject 
enrollment. Contact info is included here to keep this information centralized and secure, yet remotely 
accessible to study staff so that they do not need to keep contact information in less secure locations.
e3) Adequate written assurances that the protected health information will not be reused or 
disclosed to any other person or entity except (i) as required by law, (ii) for authorized oversight 
of the research study, or (iii) for other research for which the use or disclosure of PHI would be 
permitted by the HIPAA Privacy Rule.  By electronically signing this submission, the PI provides 
this written assurance:
Acknowledged.
f) The research could not practicably be conducted or carried out without the waiver or alteration:
Explain why informed consent/authorization can not be obtained from subjects.   
It would be impractical to consent subjects who have not been identified or to re-consent subject who 
have already given prior consent to be part of a registry.  The study does not have the resources or the 
bandwidth to contact a large number of subjects for screening and ascertainment.
g) The research could not practicably be conducted or carried out without access to and use of 
the protected health information:
It is necessary and respectful of  subjects' time to be able to identify them as potentially eligible prior to 
contacting with them.
h) For research using biospecimens or identifiable information, the research could not practicably 
be carried out without access to and use of the protected health information:
Aggregate data are not appropriate for this research. We need patient level data to identify potential 
subjects. The maintaining of a basic screening log is needed to ensure that we do not contact people 
multiple times and to ensure equitable recruitment of people among race and education levels (via 
aggregate analyses). Contact info is included in the secure Duke REDCap screening log to keep this 
information centralized and secure, yet remotely accessible to study staff so that they do not need to keep 
contact information in less secure locations.
Waiver of Documentation of Consent and HIPAA Authorization for Scheduling in MaestroCare and/or the 
recording of PHI via telephone for screening purposes:
These research activities prior to obtaining written consent for the study presents no more than 
minimal risk of harm to subjects:
True 
False 
These are procedures for which written consent is normally not required outside of the research 
context:
True 
False 
An IRB-approved phone script will be used to obtain verbal consent from subjects for scheduling 
and/or screening prior to obtaining written consent for the study:

True 
False 
 
IRB Notification of Decedent Research
In accordance with 45CFR164.512(i)(1)(iii), the IRB must approve research involving decedent's private health 
information.  In order for the IRB to make the determination, please respond to each item in the allotted space 
below, using protocol-specific language to provide justification.
Provide a brief, meaningful description of the protected health information for which use or access has been 
determined to be necessary:
While it is not the intent to directly engage in decedent research, there is the possibility that subjects will 
expire while enrolled in this research and we will want to get information regarding their death.  We would 
access name, address, date of birth and date of death. 
Check each statement below to attest to your knowledge that:
The PHI to be used will be used solely for research.
All subjects to whom this form applies will be dead.
The PHI is necessary for the research.
You will not disclose such PHI (share with anyone from outside DUHS or the SOM/SON) without first 
removing all direct identifiers, and also all indirect identifiers including information about the patient's 
age if greater than 89 years (state instead that the age is 90+ years), any dates of health-related 
events, and any patient's address more specific than state or 3 digit zip code (thus the data become 
de-identified). 
Alternatively, you may choose to disclose this PHI, but, if so, you declare that you will maintain an 
accounting of this disclosure (commonly referred to as "tracking" the disclosure) for the patient's next 
of kin if requested. 
 
Drugs, Biologics, and Other Substances
Select Protocol Phase (for studies with FDA regulated drugs or biologics only). Choose only one:
Phase 0 
Phase I 
Phase I/II 
Phase II 
Phase II/III 
Phase III 
Phase IV 
N/A 
Pilot 
Drugs, biologics, or other substances being evaluated as a part of this research study:
Add all drugs, biologics, or other substances being evaluated as a part of this research study for which an IND 
is provided for the indication used in this study.
Also add any other drugs, biologics or other substances here that are being used as a part of this research 
study, for which an 
.
IND is not provided
 
List every other drug, biologic or other substance for which side effects are described in the consent form.
View 
Drug Name
FDA Approved
A new drug or a 
new use of 
IND Number

Details
approved drug:
Drug/Biologic
/Substance 
Generic Name:
Alprazolam
Generic Drug 
Name:
Investigational 
Drug Name:
Yes 
No 
 
Drug/Biologic/Substance Generic 
Name:
Alprazolam 
Generic Drug Name:
 
Investigational Drug Name:
 
Drug/Biologic/Substance Source:
 
Is the drug/substance being 
provided to the subject free-of-
charge?
Yes  
Is the Drug FDA Approved?:
Yes  
Is this drug/biologic or other 
chemical, metabolite, nutritional 
substance or other substance to 
be used in this research subject to 
the provisions of the Controlled 
Substances Act?
No  
Does this Drug have an IND 
Number?
No  
IND Number
 
IND Holder:
N/A  
IND details:
 
If FDA Approved and an IND is 
not required, Please provide a 
rationale for exemption:
This drug is used only for anxiety related to MRI and/or lumbar 
puncture. It is not being studied for safety and/or efficacy and is 
used according to its label.  
Will drug/substance be shipped 
from Duke to external locations
No  
Dose Range:
0.25-0.5 mg  
Frequency:
once  
Will this drug, biologic, chemical, 
metabolite, nutritional substance 
or other substance be 
manufactured or compounded at 
Duke?
No  
Drug Storage Restrictions 
(including temperature, etc.):
None  
As indicated in the Investigator's 
Brochure or other available 
documentation, what is the 
highest FDA Use-in-Pregnancy 
Rating for drug used for research 
purposes in this study?:
Category D  
Drug/Biologic
/Substance 
Generic Name:
Lorazepam
Generic Drug 
Name:
Investigational 
Drug Name:
Yes 
No 
 

Drug/Biologic/Substance Generic 
Name:
Lorazepam 
Generic Drug Name:
 
Investigational Drug Name:
 
Drug/Biologic/Substance Source:
 
Is the drug/substance being 
provided to the subject free-of-
charge?
Yes  
Is the Drug FDA Approved?:
Yes  
Is this drug/biologic or other 
chemical, metabolite, nutritional 
substance or other substance to 
be used in this research subject to 
the provisions of the Controlled 
Substances Act?
No  
Does this Drug have an IND 
Number?
No  
IND Number
 
IND Holder:
N/A  
IND details:
 
If FDA Approved and an IND is 
not required, Please provide a 
rationale for exemption:
This drug is not being studied for safety and/or efficacy. It will be 
used according to label and provided to subjects who may require 
an anxiolytic for MRI and/or lumbar puncture  
Will drug/substance be shipped 
from Duke to external locations
No  
Dose Range:
0.5 mg  
Frequency:
once  
Will this drug, biologic, chemical, 
metabolite, nutritional substance 
or other substance be 
manufactured or compounded at 
Duke?
No  
Drug Storage Restrictions 
(including temperature, etc.):
None  
As indicated in the Investigator's 
Brochure or other available 
documentation, what is the 
highest FDA Use-in-Pregnancy 
Rating for drug used for research 
purposes in this study?:
Category D  
Drug/Biologic
/Substance 
Generic Name:
PiB C11
Generic Drug 
Name:
Investigational 
Drug Name:
No 
No 
 
Drug/Biologic/Substance Generic 
Name:
PiB C11 
Generic Drug Name:
 
Investigational Drug Name:
 
Drug/Biologic/Substance Source:
UNC BRIC Radiochemistry Core  
Is the drug/substance being 

provided to the subject free-of-
charge?
Yes  
Is the Drug FDA Approved?:
No  
Is this drug/biologic or other 
chemical, metabolite, nutritional 
substance or other substance to 
be used in this research subject to 
the provisions of the Controlled 
Substances Act?
No  
Does this Drug have an IND 
Number?
No  
IND Number
 
IND Holder:
N/A  
IND details:
UNC Radioactive Drug Research Committee (RDRC) approval has 
been obtained and has been attached.  
If FDA Approved and an IND is 
not required, Please provide a 
rationale for exemption:
 
Will drug/substance be shipped 
from Duke to external locations
No  
Dose Range:
 
Frequency:
 
Will this drug, biologic, chemical, 
metabolite, nutritional substance 
or other substance be 
manufactured or compounded at 
Duke?
No  
Drug Storage Restrictions 
(including temperature, etc.):
 
As indicated in the Investigator's 
Brochure or other available 
documentation, what is the 
highest FDA Use-in-Pregnancy 
Rating for drug used for research 
purposes in this study?:
 
Drug/Biologic
/Substance 
Generic Name:
F-MK6240
Generic Drug 
Name:
Investigational 
Drug Name:
No 
No 
 
Drug/Biologic/Substance Generic 
Name:
F-MK6240 
Generic Drug Name:
 
Investigational Drug Name:
 
Drug/Biologic/Substance Source:
UNC BRIC Radiochemistry Core  
Is the drug/substance being 
provided to the subject free-of-
charge?
Yes  
Is the Drug FDA Approved?:
No  
Is this drug/biologic or other 
chemical, metabolite, nutritional 
substance or other substance to 
be used in this research subject to 
No  

the provisions of the Controlled 
Substances Act?
Does this Drug have an IND 
Number?
No  
IND Number
 
IND Holder:
N/A  
IND details:
UNC Radioactive Drug Research Committee (RDRC) approval has 
been obtained and has been attached.  
If FDA Approved and an IND is 
not required, Please provide a 
rationale for exemption:
 
Will drug/substance be shipped 
from Duke to external locations
No  
Dose Range:
 
Frequency:
 
Will this drug, biologic, chemical, 
metabolite, nutritional substance 
or other substance be 
manufactured or compounded at 
Duke?
No  
Drug Storage Restrictions 
(including temperature, etc.):
 
As indicated in the Investigator's 
Brochure or other available 
documentation, what is the 
highest FDA Use-in-Pregnancy 
Rating for drug used for research 
purposes in this study?:
 
Are you using an investigational pharmacy at Duke?
Please be aware that inpatient administration of an investigational drug requires the use of the Duke IDS or 
Oncology ICS, as per Department of Pharmacy policy.
  Yes   
  No
Who will be responsible for the storage, inventory and control of the drug/biologic or other chemical, 
metabolite, nutritional substance or other substance to be evaluated in this research?
The IDS is available to assist any investigator (upon request) with storage and control of investigational drugs 
in the outpatient setting
This drug will be prescribed to participants as needed for anxiety related to MRI and/or lumbar puncture. 
They will pick it up from their pharmacy as they would their usual prescriptions. The study will provide the 
drug free of charge to those who require this.
Where will the drug/biologic or other chemical, metabolite, nutritional substance, or other substance to be 
evaluated in this research be stored?
N/A - drugs not being evaluated. Patient with get from their local pharmacy
From where will the drug/biologic or other chemical, metabolite, nutritional substance or other substance to 
be evaluated in this research be dispensed?
 Patient with get from their local pharmacy

At the completion of this research study, what will be done with the unused or returned investigational drug
/biologic or other chemical, metabolite, nutritional substance or other substance?
N/A - drugs not subject of this research
 
Privacy and Confidentiality
Explain how you will ensure that the subject's privacy will be protected:
Consider privacy interests regarding time and place where subjects provide information, the nature of the 
information they provide, and the type of experience they will be asked to participate in during the research.
All clinical history and exams will take place at Duke and UNC sites including: Duke Neurology Outpatient 
Clinic at Morreene Road, the ADRC offices in the Hock Plaza Building (2424 Erwin Road, Suite 103), 
appropriate UNC sites/clinics and also the PACU area where anesthesiologists can conduct the lumbar 
punctures or blood patches in a secure and confidential clinical and research setting (or as otherwise 
approved via phone/video interview). All procedures and imaging will take place in a secure and 
confidential clinical and research setting. The information provided is part of the UDS, a national 
standardized tool. 
Describe how research data will be stored and secured to ensure confidentiality:
How will the research records and data be protected against inappropriate use or disclosure, or malicious or 
accidental loss or destruction? Records and data include, for example, informed consent documents, case 
report forms or study flow sheets, survey instruments, database or spreadsheets, screening logs or telephone 
eligibility sheets, web based information gathering tools, audio/video/photo recordings of subjects, labeled 
specimens, data about subjects, and subject identifiers such as social security number.
The Duke/UNC ADRC is an NIA designated ADRC program. Data gathered as part of the Uniform Data Set 
(UDS) will be managed by core data personnel in the Duke/UNC ADRC and stored in Redcap at Duke. 
Redcap will transmit the data securely to NACC. Imaging data will be stored on secure servers within the 
Duke/UNC ADRC. Subject consents will be either uploaded into REDCap, or entered there directly via 
eConsent.
Data previously collected under the Bryan ADRC protocols for venipuncture and CSF is stored on a secure 
server in the Duke ADRC.
All data for the UDS will be collected electronically and transmitted into Redcap where it will be stored.
MRI images will be stored on Duke Radiology and Duke-UNC Brain Imaging and Analysis Center (BIAC) 
servers.
VRFCAT-SLx is run off an i-pad tablet device.  It is a single user interface with each user being provided 
their own log-in credentials and PIN by the Duke study team.  The software will already be preloaded onto 
the i-pad and are initiated by the participant when they are ready to begin the assessment. All digital 
assessment files will be coded and stored with participant identification numbers only; no personally 
identifying information will be attached to the files. These data files will be electronically transmitted to 
WCG servers in Cary NC via their secure web-based portal.  
Data will be processed and cleaned at WCG. Quarterly data transfers will occur back to the Duke/UNC 
ADRC through a secure portal (Duke Box). VRFCAT use with participants will begin now that all required 
data agreements have been completed between Duke/UNC and WCG-VeriSci.
All data/specimens released from the Duke/UNC ADRC database/repository are de-identified or represent 
data elements that cannot be de-identified (retinal images, voice recordings, whole genome data or DNA) 
but these data are not connected to other PHI and are released only with permission (opt in) of the 
participant. 
Every effort will be made to secure participants identity, health information and research results. The 
study will assign each participant a unique global ID (UGID) and use additional consistent ID’s to link UDS 
data, images, and biomarkers stored by Substrate Services Core Research Support (SSCRS). All 
information will be stored in the ARENA, a data management system with multi-layered security levels, 
which will ensure participant confidentiality during all phases of the study.  The ARENA integrates several 

platforms including REDCap and PEDIGENE (an ORACLE-based system for managing complex genetic and –
omic data) and links to EPIC and other secure servers to allow data transfer between Duke and outside 
entities in a secure manner. The ARENA will transmit data securely to NACC. 
All data/specimens are coded by a unique Duke/UNC ADRC global ID number rather than by name.  Data 
and specimen information are maintained in the ARENA database according to identifier number and not 
by name. All data/specimens released from the ARENA database and biorepository managed by Substrate 
Services Core Research Support (SSCRS) are de-identified [or represent data elements that cannot be de-
identified (retinal images, voice recordings, whole genome data or DNA) but these data are not connected 
to other PHI and are released only with permission (opt in) of the participant] and given a unique ID 
number linked to the global ID number.  All original (primary) data are stored in locked cabinets in a 
locked room with access strictly controlled by ADRC research staff.  No specimens/data are ever released 
to third outside parties unless the participant (or the participant’s legal representative) has requested and 
consented to data release (e.g. for medical purposes).  A strict confidentiality policy is in place for all ADRC 
research staff.  Access to the data is restricted and protected as required by law and can only be accessed 
by authorized investigators and research staff. The database/repository will be maintained indefinitely as 
long as funding is available or until the data/specimens are exhausted.
The basic screening and enrollment logs, maintained securely in Duke REDCap, will have access limited to 
appropriate ADRC study team members, via REDCap roles and credentialing.
 
Application Questions Complete
Please click Save & Continue to proceed to the Initial Submission Packet.
The Initial Submission Packet is a short form filled out after the protocol application has been completed.  This 
is an area to attach protocol-related documents, consent forms, and review the application.