Conditions: Alzheimer's Disease Dementia
Keywords: deprescribing medication therapy management
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 90
Healthy volunteers: no

Brief summary:
The study will examine the impact on cognitive reserve of a pharmacist-physician patient-centered medication therapy management intervention to address inappropriate medication use as identified by the Beers 2015 list. By bolstering cognitive reserve, this project will directly address the National Alzheimer's Project Act 2015 priorities serving to delay onset of symptoms in preclinical dementia. The results of this study will provide valuable insights on how to expand this intervention to reduce the prevalence and associated healthcare costs of symptomatic Alzheimer's disease.

Detailed description:
This is a 12-month, parallel arm, study to be conducted at the University of Kentucky. The study will involve assessing medication use and identifying any medicines that may be inappropriate for elderly adults.

At the beginning of the study, participants will be asked to undergo one amyloid-PET scan to detect early amyloid plaques in their brain which could increase the risk of Alzheimer's disease in the near future. In addition, at the beginning and end of the study, participants will be asked to use a scopolamine patch. This patch is not being used to prevent motion sickness (as approved by the FDA), but instead is being used to challenge the participant's memory and thinking abilities.

Part of the study includes collecting information regarding participants memory and thinking abilities. Participants will be asked to complete questionnaires as well as memory and thinking tests.

A study doctor will review participants medical history and then perform routine medical (physical and neurological) examinations.

Two of the study visits will be conducted by phone to check up on the participants.

At the beginning, middle, and end of the study, participants will meet with a doctor and pharmacist to review and make any changes deemed appropriate to their current medicines. This will be done in order to try and eliminate medicines that are not recommended for the elderly. These visits are referred to as the Medication Therapy Management (MTM).

Arms:
arm 1: Participants enrolled into this arm will only receive educational materials, but will not receive specific recommendations to make changes to the medications they are taking.

Cognitive testing at the beginning and the end of the study will be done with and without a scopolamine patch to reveal cognitive reserve. arm 2: Participants enrolled into this arm will receive educational materials and will have their medications assessed; recommendations for changes in the medications taken will be made when appropriate.

Cognitive testing at the beginning and the end of the study will be done with and without a scopolamine patch to reveal cognitive reserve.

Interventions: intervention 1: Placebo intervention 2: Medication Therapy Management (MTM) intervention 3: Scopolamine patch
Intervention descriptions: intervention 1: Participants will receive educational materials, but will not receive MTM. intervention 2: Participants will receive MTM in addition to the educational materials. intervention 3: At the beginning and end of the study, participants will be asked to use a scopolamine patch. This patch is not being used to prevent motion sickness (as approved by the FDA), but instead is being used to challenge the participant's memory and thinking abilities and determine cognitive reserve.

Protocol document:
ICF_000.pdf: 
Informed Consent  
 
 Study Title: INtervention for Cognitive Reserve Enhancement in Delaying the Onset of Alzheimer's 
Symptomatic Expression: The INCREASE Study   
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
11/20/2019 
NCT Number: 
NCT02849639 
IRB Number 
16-0375-F2L 
Coversheet created: 
11/8/2021 
 
 


INCREASE 
Version 7 
Dated: 10/31/2019 
 
1 
           
 
Combined Consent and Authorization to Participate in a Research Study 
 
INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer’s Symptomatic 
Expression: The INCREASE study 
 
WHY ARE YOU BEING INVITED TO TAKE PART IN THIS RESEARCH? 
 
You are being invited to take part in a research study to see the effects of changing your medications on 
the onset of memory and thinking problems caused by Alzheimer’s disease or other disorders of aging. 
You are being invited to take part in this research study because you are a normal elderly person that is 
taking medications that have been identified as potentially not appropriate for someone your age.  If you 
volunteer to take part in this study, you will be one of about 90 people to do so at the University of 
Kentucky.  
 
WHO IS DOING THE STUDY? 
 
The person in charge of this study is Daniela Moga, M.D., Ph.D. of University of Kentucky, Department 
of Pharmacy Practice and Science, and Department of Epidemiology.  Gregory A. Jicha, M.D., Ph.D. 
will also be assisting with the study and will serve as the study physician.  There may be other people on 
the research team assisting at different times during the study.  
 
WHAT IS THE PURPOSE OF THIS STUDY? 
 
By doing this study, we hope to learn the effects of changing any potentially inappropriate medications 
you currently take, on Alzheimer’s disease or other disorders of aging. 
 
The purpose of this research is to gather information on how safe and effective reducing your use of 
inappropriate medications is. We will use a scopolamine patch (like those commonly used to treat or 
prevent motion sickness) to help us understand the effect of potentially inappropriate medications on 
your memory and thinking.  The results of this study may be shared with federal agencies. 
 
ARE THERE REASONS WHY YOU SHOULD NOT TAKE PART IN THIS STUDY? 
 
You should not participate in this study if you do not wish to consider changing your current medicines, 
or if you have an allergy or other known intolerance to scopolamine patches that are commonly used to 
treat or prevent motion sickness. 
 
Other reasons why you should not participate include narrow-angle glaucoma, difficulty swallowing, 
stomach or bowel problems (e.g., blockage, muscle weakness, ulcerative colitis), bleeding, myasthenia 
gravis, seizures, or a blockage of the urinary tract which could be worsened by use of the scopolamine 
patch that is part of the study. 
 
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST?  
 
The research procedures will be conducted at the Sanders Brown Center on Aging, 1030 South 
Broadway, Suite #5, Lexington, KY and the UK Department of Radiology PET scan facilities on 
campus. You will need to come to the Sanders Brown Center on Aging, 1030 South Broadway, Suite #5, 
Lexington, KY, 6 times during the study.  Each of those visits will take about 2 to 5 hours.  The total 
amount of time you will be asked to volunteer for this study is about 40 hours over the next 62 weeks. 
 
 
IRB Approval
11/20/2019
IRB # 43239
IRB2


INCREASE 
Version 7 
Dated: 10/31/2019 
 
2 
WHAT WILL YOU BE ASKED TO DO? 
 
The study will involve assessing your medication use and identifying any medicines that may be 
inappropriate for someone your age. This will be done by a team including both a study doctor and a 
pharmacist with expertise in medication use for the elderly.  
 
The following is a table of the study procedures you will undergo as part of your study participation if 
you decide to enroll in the study: 
 
Procedure 
Screening 
Baseline scopolamine 
Month 
3 
Month 
6 
Month 
9 
EOS scopolamine 
Challenged 
Non- 
challenged 
Challenged 
Non- 
challenged 
Study week 
-5 ± 2 
weeks 
-4 ± 1 week 
0 ± 1 week 
13 ± 1 
week 
26 ± 1 
week 
39 ± 1 
week 
52 ± 1 
week 
56 ± 1 
week 
Demographics 
X 
Health History 
X 
X 
X 
X 
X 
X 
X 
X 
Medication Review 
X 
X 
X 
X 
X 
X 
X 
X 
Vital Signs 
X 
X 
X 
 
X 
 
X 
X 
NART 
X 
MoCA 
X 
X 
X 
X 
CVLT 
X 
X 
X 
X 
TMTB 
X 
X 
X 
X 
SF-36 
X 
X 
Gait & Balance Test 
X 
X 
 
X 
X 
X 
Lifestyle Factor Q. 
X 
X 
Baseline Q. 
X 
 
EOS Q. 
 
X 
ECG 
X 
Physical exam 
X 
X 
Neurological exam 
X 
X 
Aβ-PET imaging 
X 
Scopolamine Patch 
X 
 
X 
MTM Intervention 
X 
X 
X 
Telephone check 
X 
X 
 
As part of the study (at the beginning and end) you will be asked to put on a scopolamine patch behind 
your ear as many people your age do when traveling by air or on a cruise ship to prevent motion 
sickness. This patch is not being used to prevent motion sickness in this study, but instead is being used 
to challenge your memory and thinking abilities. On the two days you are asked to wear the patch, you 
will need to find someone to drive you to and from your research appointment. 
 
You will also be asked to undergo an amyloid-PET scan which will tell the study investigators if you 
have early amyloid plaques in your brain that could increase your risk of Alzheimer’s disease in the near 
future. The study staff will not tell you if you have amyloid plaques or not if you choose to participate in 
the study, as there are no approved treatments or interventions for amyloid plaques in persons with 
normal memory and thinking currently available. The amyloid-PET scan will take about 20 minutes, but 
you will first need an IV placed and have a dose of tracer that contains radioactivity injected into your 
veins. The amount of radioactivity is low and will quickly wash out of your system. You will have only 
one PET scan at enrollment in the study as part of this research project. This procedure will take about 
1-2 hours in total and you will be in the scanner for about 20 minutes or so as part of this procedure. 
 
Part of the study includes collecting information on your memory and thinking abilities. This will 
include both questionnaires as well as memory and thinking tests. This will be performed 4 times during 
your study visits over the entire study period. These tests will take less than one hour every time they are 
performed. 
43239


I N C R E A S E 
V er si o n  7 
D at e d: 1 0 /3 1/ 2 0 1 9 
 
3  
 
Y o u will als o be as ke d t o u n der g o tests of y o ur gait a n d bala nce. T he tests will i n v ol ve wal ki n g o n a n 
electr o nic press ure -se nsiti ve wal k wa y a n d c o m pleti n g vari o us p h ysical tas ks w hile weari n g si x watc h-
size d se ns ors. S h o ul d y o u a gree, t h ese gait a n d b ala nce tests will be vi de o rec or de d t o h el p t he st u d y 
d oct ors better u n dersta n d y o ur test res ults. T he vi d e o rec or di n gs will n ot ca pt ure y o ur face; o nl y y o ur 
b o d y fr o m y o ur s h o ul ders d o w n will be i n fra me. T hese tests will occ ur fi ve ti mes t hr o u g h o ut t he 
st u d y, a n d t he y will ta ke less t ha n t hirt y mi n utes eac h ti me t he y are perf or me d.  
 
D o y o u gi ve t h e st u d y tea m per missi o n t o vi de o rec or d y o ur gait a n d bala n ce test sessi o ns?  
 
 Yes  N o _ _ _ _ _ _ _ _ _I niti als   
  
 
 Yes  N o _ _ _ _ _ _ _ _ _ L A R I niti als   
 
A st u d y d oct or will re vie w y o ur me dical hist or y wit h y o u, a n d t he n p erf or m a r o uti ne me dical ( p h ysi cal 
a n d ne ur ol o gic) e x a mi nati o n. T his will be d o ne t wice d uri n g t he st u d y, o nce at t he be gi n ni n g a n d a gai n 
at t he e n d.  
 
A n E C G ( heart traci n g) will als o be d o ne at t he b e gi n ni n g of t he st u d y t o s ee t he p ote ntial effects y o ur 
me dici nes o n y o ur heart r h yt h m a n d t o e ns ure t hat me dicati o n c ha n ges are safe f or y o u. 
 
Vital si g ns will be o btai n e d at all o n -site st u d y visits. 
T w o of t he st u d y visits will be c o n d ucte d b y p h o n e t o c hec k u p o n y o u a n d y o ur h ealt h c o n diti o ns. 
 
At t he be gi n ni n g, mi d dle, a n d e n d of t he st u d y, y o u ma y  meet wit h a d oct or a n d p har macist t o re vie w 
a n d ma ke a n y c ha n ges t o y o ur me dici nes t hat are nee de d t o eli mi nate me di ci nes o n y o ur list t hat are n ot 
rec o m me n de d f or t he elderl y. T hese visits are referre d t o as t he M e dicati o n T hera p y Ma n a ge me nt 
( M T M) visits bel o w. 
 
W H A T A R E T H E P O S SI B L E RI S K S A N D DI S C O M F O R T S ?  
 
Me m or y a n d t hi n ki n g testi n g:  T hese st u d y pr o ce d ures c o ul d ca use a n xiet y, fati g ue or b ore d o m. 
 
E C G:  T h e E C G (electr o car di o gr a m) is a pict ure of t he electrical acti vit y of t he heart. D uri n g t his 
pr oce d ur e y o u will nee d t o lie still f or a fe w mi n utes w hile electr o des are attac he d t o y o ur c h est.  T h e 
electr o des m a y ca us e s o me disc o mf ort w he n t he y are p ut o n a n d ta k e n off y o ur s ki n.  If y o u are a m ale 
a n d ha ve a n y c hest hair, it ma y nee d t o be s ha v e d off i n t he areas w h ere t he electr o des will be place d.  
 
Ris ks of P E T Sc a ns : Bei n g i n t he P E T sca n n er m a y ca use y o u t o e x perie n ce disc o mf ort or 
m usc ul os keletal pai n, s uc h as bac k or nec k pai n. S o me pe o ple d o n ot li ke t he s mall s pace 
(cla ustr o p h o bia) a n d mi g ht feel c o nfi n e d or b ot here d b y b ei n g i n t he P E T sca n mac hi n e f or a l o n g 
peri o d of ti me. 
 
Ris ks of R a di ati o n E x p os ure : T his researc h st u d y i n v ol ves e x p os ure t o ra diati o n fr o m p ositr o n 
e missi o n t o m o gra p h y ( P E T) sca ns.  Pleas e n ote t hat t his ra diati o n e x p os ure is n ot necessar y f or y o ur 
me dical care a n d is f or researc h p ur p oses o nl y.  T he t otal a m o u nt of ra diati o n y o u will recei ve d uri n g 
t he 1 P E T sca n sessi o n s i n t his st u d y is fr o m 1 i njecti o n of 1 8 F- Fl or beta pir. Alt h o u g h eac h or ga n will 
recei v e a diff er e nt d ose, t he a m o u nt of ra di ati o n e x p os ure y o u will recei ve fr o m t his st u d y is e q ual t o a 
u nif or m w h ole- b o d y e x p os ure of u p t o 1. 5 2 re m, w hic h is t he e q ui vale nt of a p pr o xi matel y 5 years of 
e x p os ure fr o m nat ural e n vir o n me ntal s o urces.  T his val ue is k n o w n as t he “effecti ve d ose e q ui v ale nt ” 
a n d is use d t o relate t he d ose recei ve d b y eac h or ga n t o a si n gle v al ue.  T his a m o u nt of ra diati o n 
e x p os ure is bel o w t he a n n ual li mit of 5 -re m set b y t he fe deral g o ver n m e nt f or researc h s u bjects. 
 
T he eff ects of ra diati o n e x p os ure o n h u ma ns ha ve bee n st u die d f or o v er 6 0 years.  I n fact, t hes e st u dies 
are t he m ost e xte nsi ve e v er d o ne of a n y p ote ntiall y har mf ul a ge nt t hat c o ul d affect h u ma ns.  I n all t hese 
st u dies, n o har mf ul eff ect t o h u ma ns has bee n o bser ve d fr o m t he le v els of ra diati o n y o u will recei ve b y 
4 3 2 3 9


INCREASE 
Version 7 
Dated: 10/31/2019 
 
4 
taking part in this research study.  However, scientists disagree on whether radiation doses at these 
levels are harmful.  Even though no effects have been observed, some scientists believe that radiation 
can be harmful and may cause cancer at any dose- even low doses such as those received during this 
research. 
 
Please tell your study doctor or other study personnel if you have taken part in other research studies that 
used radiation.  This way we can make sure that you will not receive too much radiation.  You should 
consider x-rays taken in radiology departments, cardiac catheterization, and fluoroscopy as well as 
nuclear medicine scans in which radioactive materials were injected into your body.  Before you take 
part in any future studies that use radiation, you should also tell those study doctors about your 
participation in this study. 
If you are pregnant, breast-feeding, or of childbearing potential you may not participate in this research 
study.   
 
Risks of 18F-Florbetapir: The most common side effect in completed studies with florbetapir was 
headache, which was reported in less than 2% of subjects. Additional uncommon (reported by 0.1% to 
1.0% of subjects) side effects reported were: musculoskeletal (muscle and bone) pain, increased blood 
pressure/hypertension, nausea, fatigue, injection site reaction (bleeding, irritation, pain), anxiety, back 
pain, claustrophobia (fear of being in closed or narrow spaces), dizziness, feeling cold/chills, insomnia 
(inability to sleep), neck pain, infusion site rash, dysgeusia (bad taste in the mouth), pruritus (itching), 
urticaria (hives), and flushing. 
 
Risks of gait and balance testing: The risks of completing gait and balance testing five times during 
the study are no greater than your risks while walking in daily life. It is possible that you may trip or lose 
your balance during the test session. All gait and balance tests will be performed only by trained study 
personnel who are equipped to prevent falls 
 
Risk of scopolamine patch: The risks of using a scopolamine patch twice during the study for a day 
each is low. This patch is used commonly in the elderly for the prevention and or treatment of motion 
sickness associated with travel by land, sea, or air. The scopolamine patch can however cause some 
temporary adverse side effects that are detailed below. In this study we are using the patch to provoke 
memory and thinking problems. In the elderly this can be a common side effect of this medicine. 
 
 
 
*The FDA-approved package insert will be provided to all research participants enrolled in the study for 
review prior to consent. 
 
Risk of intervention vs. placebo: If you are assigned to the placebo group, you are at no increased risk 
over standard clinical care which you are already receiving. If you have concerns about the 
appropriateness of your medicines, you are free to discuss with your doctor or pharmacist. The risks of 
43239


INCREASE 
Version 7 
Dated: 10/31/2019 
 
5 
being assigned to the interventional arm include the possibility of being recommended a change in your 
current medications in line with current medical recommendations. Changing your medications could 
result in worsening or improvement of your medical symptoms for which your current medications are 
being prescribed. If you experience side effects or worsening of your medical conditions, the study team 
will work with your primary care doctor to find suitable alternatives or recommend that you return to 
your previous medicine that was managing your symptoms when you enrolled in the study. Change of 
medications indicated by the study team will follow standard of care practices and should lead to no 
more risk of harm than that associated with regular doctor visits and medication changes. 
 
There is always a chance that any medical treatment can harm you, and the investigational treatment in 
this study is no different.  In addition to the risks listed above, you may experience a previously 
unknown risk or side effect. 
 
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
 
There is no guarantee that you will get any benefit from taking part in this study.  However, some people 
have experienced improved memory and thinking when inappropriate medications are replaced with 
more appropriate alternatives.  Your willingness to take part, however, may also, in the future, help 
doctors better understand and/or treat others who are at risk for memory and thinking problems as they 
age. 
 
DO YOU HAVE TO TAKE PART IN THE STUDY? 
 
If you decide to take part in the study, it should be because you really want to volunteer.  You will not 
lose any benefits or rights you would normally have if you choose not to volunteer.  You can stop at any 
time during the study and still keep the benefits and rights you had before volunteering.  If you decide 
not to take part in this study, your decision will have no effect on the quality of medical care you 
receive. 
 
IF YOU DON’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES? 
 
If you do not want to take part in the study, there are other choices such as discussing the 
appropriateness of your medications with your doctor and pharmacist. You may be able to work with 
them to reduce your use of inappropriate medicines without study participation. 
 
WHAT WILL IT COST YOU TO PARTICIPATE? 
 
You and/or your insurance company, Medicare or Medicaid will be responsible for the costs of all care 
and treatment you receive during this study that you would normally receive for your condition. These 
are costs that are considered medically reasonable and necessary and will be part of the care you receive 
if you do not take part in this study. 
 
No study procedures will be billed to you or your insurance.  
 
However in this study, the study doctors and pharmacists may recommend changes to you medications 
that could potentially result in higher costs to you (deductible or other out-of-pocket expenses). The study 
team will work with you to find the lowest cost alternatives and if financial issues cannot be resolved, the 
study team is OK with you continuing with your current medications rather than accepting potentially 
higher cost changes. If you choose to accept a higher cost medication as part of the recommended 
medication changes, this cost will be will be your responsibility.  
 
You should know that such costs may be paid by your insurer if you are insured by a health insurance 
company (you should ask your insurer if you have any questions regarding your insurer’s willingness to 
pay these costs), or may be paid by Medicare or Medicaid if you are covered by Medicare, or Medicaid, 
(if you have any questions regarding Medicare/Medicaid coverage you should contact Medicare by calling  
 
43239


INCREASE 
Version 7 
Dated: 10/31/2019 
 
6 
1-800-Medicare (1-800-633-4227) or Medicaid at 1-800-635-2570. 
A co-payment/deductible from you may be required by your insurer or Medicare/Medicaid even if your 
insurer or Medicare/Medicaid has agreed to pay the costs.  The amount of this co-payment/deductible 
may be substantial and is your responsibility to pay. 
 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 
 
If you believe you are hurt or if you get sick because of something that is done during the study, you 
should call Dr. Gregory Jicha at (859) 323-5550 immediately.  If you are unable to reach Dr. Jicha at 
this number, you should call (859) 559-7429. 
 
It is important for you to understand that the University of Kentucky does not have funds set aside to 
pay for the cost of any care or treatment that might be necessary because you get hurt or sick while 
taking part in this study. Also, the University of Kentucky will not pay for any wages you may lose if 
you are harmed by this study.   
 
The medical costs related to your care and treatment because of research related harm will be your 
responsibility or may be paid by your insurer if you are insured by a health insurance company (you 
should ask your insurer if you have any questions regarding your insurer’s willingness to pay under 
these circumstances); and may be paid by Medicare or Medicaid if you are covered by Medicare, or 
Medicaid (if you have any questions regarding Medicare/Medicaid coverage you should contact 
Medicare by calling 1-800-Medicare (1-800-633-4227) or Medicaid 1-800-635-2570. 
 
A co-payment/deductible from you may be required by your insurer or Medicare/Medicaid even if your 
insurer or Medicare/Medicaid has agreed to pay the costs).  The amount of this co-payment/deductible 
may be substantial. 
 
You do not give up your legal rights by signing this form. 
 
WHO WILL SEE THE INFORMATION THAT YOU GIVE? 
 
We will make every effort to keep confidential all research records that identify you to the extent 
allowed by law. 
 
Your information will be combined with information from other people taking part in the study. When 
we write about the study to share it with other researchers, we will write about the combined information 
we have gathered. You will not be personally identified in these written materials. We may publish the 
results of this study; however, we will keep your name and other identifying information private.  
 
We will make every effort to prevent anyone who is not on the research team from knowing that you 
gave us information, or what that information is. Your paper records will be kept under double lock-and-
key at the Sanders-Brown Center on Aging Clinic, 1030 South Broadway Suite #5 or in the College of 
Pharmacy, 789 S Limestone. After your name and identifying information is removed, your research 
data will be uploaded through a secure web-link to an electronic database (REDCAP) that prevents 
others from accessing this information.  
 
You should know, however, that there are some circumstances in which we may have to show your 
information to other people.  For example, the law may require us to show your information to a court or 
to tell authorities if you report information about a child or vulnerable adult being abused or if you pose 
a danger to yourself or someone else.    
  
Officials of the Food and Drug Administration, the National Institutes of Health, the Center for Clinical 
and Translational Science, and the University of Kentucky may look at or copy pertinent portions of 
records that identify you. 
 
 
43239


I N C R E A S E 
V er si o n  7 
D at e d: 1 0 /3 1/ 2 0 1 9 
 
7  
 
C A N Y O U R T A KI N G P A R T I N T H E S T U D Y E N D E A R L Y ?  
 
If y o u deci d e t o ta ke part i n t he st u d y y o u still ha ve t he ri g ht t o deci de at a n y ti me t hat y o u n o l o n ger 
wa nt t o c o nti n ue. Y o u will n ot be treate d differe ntl y if y o u d eci de t o st o p ta ki n g part i n t he st u d y. 
If y o u c h o ose t o wit h dr a w fr o m t he st u d y earl y, t he data c ollecte d u ntil t hat p oi nt will re mai n i n t he 
st u d y data b ase a n d m a y n ot be re m o ve d.   
 
T he i n di vi d uals c o n d ucti n g t he st u d y ma y nee d t o wit h dra w y o u fr o m t he st u d y a n d t he st u d y 
i nter ve nti o n, me dicati o n will n o l o n ger be pr o vi de d b y t he i n vesti gat or a n d ma y n ot be accessi ble 
c o m merciall y.  T his  ma y occ ur if y o u are n ot a bl e t o f oll o w t he directi o ns t he y gi v e y o u, if t he y fi n d t hat 
y o ur b ei n g i n t he st u d y is m ore ris k t ha n be nefit t o y o u, or if t h e a ge n c y f u n di n g t he st u d y deci d es t o 
sto p t he st u d y earl y f or a variet y of scie ntifi c reas o ns.  
 
A R E Y O U P A R TI CI P A TI N G O R C A N Y O U P A R TI CI P A T E I N A N O T H E R R E S E A R C H 
S T U D Y A T T H E S A M E TI M E A S P A R TI CI P A TI N G I N T HI S O N E ?  
 
Y o u ma y t a ke part i n t his st u d y if y o u are c urre ntl y i n v ol ve d i n a n ot her res earc h st u d y.  It is i m p orta nt t o 
let t he i n vesti gat or/ y o ur d oct or k n o w if y o u are i n a n ot her researc h st u d y.  Y o u s h o ul d als o disc uss wit h 
t he i n vesti gat or b ef or e y o u a gree t o p artici pate i n a n ot her researc h st u d y w hile y o u are e nr olle d i n t his 
st u d y. 
 
WI L L Y O U R E C EI V E A N Y R E W A R D S F O R T A KI N G P A R T I N T HI S S T U D Y ?  
 
Y o u will be c o m pe nsate d $ 2 0 0. 0 0 f or ta ki n g part i n t his st u d y.  Y o u will recei ve $ 1 0 0 f or eac h 
sc o p ola mi ne c halle n ge visit, t o all o w f or tra ns p ort ati o n or l ost wa ges c osts f or st u d y p art ners t hat 
pr o vi de s uc h ser vi ce.  Y o u will recei ve at $ 1 0 0. 0 0 Visa Car d u p o n c o m pleti o n of eac h s c o p ola mi ne 
c halle n ge visit.  
If y o u ear n $ 6 0 0. 0 0 or m ore b y partici p ati n g i n researc h, it is p ote ntiall y re p orta ble f or ta x p ote ntiall y 
f or ta x p ur p oses. 
 
W H A T I F Y O U H A V E Q U E S TI O N S, S U G G E S TI O N S, C O N C E R N S, O R C O M P L AI N T S ?  
 
Bef ore y o u deci de w h et her t o acce pt t his i n vitati o n t o ta ke part i n t he st u d y, please as k a n y q uesti o ns 
t hat mi g ht c o me t o mi n d n o w.  Later, if y o u h a ve q uesti o ns, s u g gesti o ns, c o ncer ns, or c o m plai nts a b o ut 
t he st u d y, y o u ca n c o ntact t he i n vesti gat or, Dr. Da niela M o ga at ( 8 5 9) 3 2 3- 9 6 8 2.  If y o u ha ve a n y 
q uesti o ns a b o ut y o ur ri g hts as a v ol u nteer i n t his researc h, c o ntact t he staff i n t he Office of Researc h 
I nte grit y at t he U ni versit y of Ke nt uc k y b et wee n t he b usi ness h o urs of 8a m a n d 5 p m E S T, M o n-Fri at 
8 5 9- 2 5 7- 9 4 2 8 or t oll free at 1- 8 6 6- 4 0 0- 9 4 2 8. We will gi ve y o u a si g ne d c o p y of t his c o ns e nt f or m t o 
ta ke wit h y o u. 
 
W H A T I F N E W I N F O R M A TI O N I S L E A R N E D D U RI N G T H E S T U D Y T H A T MI G H T 
A F F E C T Y O U R D E CI SI O N T O P A R TI CI P A T E ?  
 
If t he res ear c her lear ns of ne w i nf or mati o n i n re gar ds t o t his st u d y, a n d it mi g ht c h a n ge y o ur willi n g n ess 
t o sta y i n t his st u d y, t he i nf or mati o n will be pr o vi de d t o y o u.  Y o u m a y be as ke d t o si g n a ne w i nf or me d 
c o nse nt f or m if t he i nf or mati o n is pr o vi de d t o y o u after y o u h a ve j oi ne d t he st u d y.  
 
C o nt acti n g Rese a rc h S u bjects f or F ut ure St u dies  
 
D o y o u gi ve y o ur per missi o n t o be c o ntacte d i n t h e f ut ure b y Drs. M o ga or Jic ha  re gar di n g y o ur 
willi n g ness t o partici pate i n f ut ure res ear c h st u dies a b o ut h o w t o pre ve nt, d etect, or treat me m or y a n d 
a gi n g pr o ble ms t hat are ass ociate d wit h a gi n g?    
 
   Yes     N o _ _ _ _ _ _ _ _ _I niti als  
  
 
 Yes  N o _ _ _ _ _ _ _ _ _ L A R I niti als 
 
4 3 2 3 9


INCREASE 
Version 7 
Dated: 10/31/2019 
 
8 
 
WHAT ELSE DO YOU NEED TO KNOW? 
 
There is a possibility that the clinical and imaging data collected from you may be shared with other 
investigators in the future.  If that is the case the clinical and imaging data will not contain information 
that can identify you unless you give your consent/authorization or the UK Institutional Review Board 
(IRB) approves the research.  The IRB is a committee that reviews ethical issues, according to federal, 
state and local regulations on research with human subjects, to make sure the study complies with these 
before approval of a research study is issued. 
 
The National Institutes of Health (NIH) is providing financial support and/or material for this study. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. 
Law. This website will not include information that can identify you.  At most, the website will include 
a summary of the results.  You can search this website at any time.  
 
AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH 
INFORMATION  
 
The privacy law, HIPAA (Health Insurance Portability and Accountability Act), requires researchers to 
protect your health information.  The following sections of the form describe how researchers may use 
your health information.   
 
Your health information that may be accessed, used and/or released includes: 
 
• Demographic information (name, initials, age, gender, race, study number, mailing address, 
email address, and home/work/cell phone numbers.) 
•  Results of physical exams 
•  Amyloid PET scan results 
•  Medical and medication history as it relates to the study 
•  Results from questionnaires 
•  Study visits 
 
The Researchers may use and share your health information with: 
 
• The University of Kentucky’s Institutional Review Board/Office of Research Integrity. 
• Law enforcement agencies when required by law. 
• University of Kentucky representatives. 
• National Institutes of Health (NIH) 
• UK Investigational Drug Service (IDS) 
• The Sanders-Brown Center on Aging Biostatistics core at the University of Kentucky 
• Members of the Data Safety Monitoring Board 
• Your primary physician will be contacted if we, in the course of the research, learn of a medical 
condition that needs immediate attention. 
 
The researchers agree to only share your health information with the people listed in this document.   
Should your health information be released to anyone that is not regulated by the privacy law, your 
health information may be shared with others without your permission; however, the use of your health 
information would still be regulated by applicable federal and state laws.   
You may not be allowed to participate in the research study if you do not sign this form.   If you decide 
not to sign the form, it will not affect your: 
• Current or future healthcare at the University of Kentucky 
• Current or future payments to the University of Kentucky   
• Ability to enroll in any health plans (if applicable) 
• Eligibility for benefits (if applicable) 
 
43239


INCREASE 
Version 7 
Dated: 10/31/2019 
 
9 
After signing the form, you can change your mind and NOT let the researcher(s) collect or release 
your health information (revoke the Authorization). If you revoke the authorization: 
 
• You will send a written letter to: Daniela Moga, MD Ph.D., Pharmacy Practice and Science, 
College of Pharmacy, 789 S Limestone Room 241, Lexington, KY 40536 to inform her of your 
decision. 
• Researchers may use and release your health information already collected for this research 
study. 
• Your protected health information may still be used and released should you have a bad reaction 
(adverse event). 
 
You understand that you will not be allowed to review the information collected for this research study 
until after the study is completed.  When the study is over, you will have the right to access the 
information. 
 
 
The use and sharing of your information has no time limit.  
 
If you have not already received a copy of the Privacy Notice, you may request one.  If you have 
any questions about your privacy rights, you should contact the University of Kentucky’s Privacy 
Officer between the business hours of 8am and 5pm EST, Mon-Fri at: (859) 323-1184. 
 
You are the subject or are authorized to act on behalf of the subject.  You have read this 
information, and you will receive a copy of this form after it is signed. 
 
 
_________________________________                         ____________________________ 
Signature of research subject  
 
 
         Date 
 
 
 
 
 
 
 
_________________________________ 
 
 
 
Printed name of research subject 
 
 
 
 
 
__________________________________                          ____________________________ 
Signature of Subject Legally Authorized  
 
          Date 
 
Representative 
 
 
 
 
 
__________________________________           
          ____________________________ 
Name of [authorized] person obtaining 
 
          Date 
 
 
  
informed consent/HIPAA authorization    
 
 
  
 
 
 
_________________________________________ 
Signature of Principal Investigator or Sub/Co-Investigator 
 
 
 
43239

SAP_002.pdf: 
Study Title: Intervention for Cognitive 
Reserve Enhancement in delaying the 
onset of Alzheimer’s Symptomatic 
Expression (INCREASE) Study 
 
 
ClinicalTrials.gov NCT02849639 
 
 
Developed: December 14, 2015 
 


Statistical analyses  
We will use Student’s t-tests (or Wilcoxon rank sum tests for non-normally distributed 
variables) and chi-square or Fisher’s exact tests to assess the comparability of randomized 
study groups. To examine the effect of the intervention on prescribing appropriateness we will 
perform analysis of covariance (ANCOVA), with the dependent variables being the difference 
between MAI scores at baseline and the follow-up measure. We will control for any variables 
that might be significantly different between groups at baseline that have not already been 
included in the study protocol in regards to stratification of subjects.  
Data evaluating cognitive reserve will be analyzed by intervention groups. For Aim 2, the 
impact on cognitive reserve will be assessed across the full range of SUVR (i.e., SUVR will be 
included in the analysis as continuous variable). If imbalance exists between groups after 
randomization, covariates for analysis will include age, gender, education, NART scores, and 
the number of targeted inappropriate medications using 2015 Beers Criteria. We will investigate 
change from baseline in CRCS by group using ANCOVA. 
For the perceived health status measure, because the SF-36 does not produce a single 
overall measure and because of our concern regarding multiple comparisons, multivariate 
analysis of covariance (MANCOVA) will be used to simultaneously estimate the effect of the 
intervention on the eight SF-36 health concepts. Similarly, we will also control for any variables 
that might be significantly different between groups at baseline. 
 

Prot_001.pdf: 
PROTOCOL TYPE
Which IRB
Medical
NonMedical
Protocol Process Type
Exemption
Expedited
Full
(Must be risk level 1)
 
Section 1 Page 1 of 1
IRB Approval
2/27/2018
IRB # 43239


PROJECT INFORMATION
Title of Project: (If applicable, use the exact title listed in the grant/contract application). 
Intervention for Cognitive Reserve Enhancement in
delaying the onset of Alzheimer's Symptomatic
Expression: The INCREASE Study
Short Title Description 
Note: "Short Title" should consist of a couple key words to easily identify your study - these key words (rather than the whole title) will
be displayed on the Dashboard in the listing for your study.
INCREASE
Anticipated Ending Date of Research Project:
Number of human subjects 
90
Study is/will be open to new subject enrollment (or data/specimen collection):
Yes
No
5/1/2021
Section 2 Page 1 of 1
43239


PI CONTACT INFORMATION
The Principal Investigator's (PI) contact information is filled in automatically based on who was logged in when the application was
created (with LinkBlue ID). If research is being submitted to or supported by an extramural funding agency such as NIH, a private
foundation or a pharmaceutical/manufacturing company, the PI listed on the grant application or the drug protocol must be the same
person listed below. 
If you are not the Principal Investigator, do NOT add yourself as study personnel. You may change the PI contact information on an
application that is in Researcher edit mode by:
clicking the "Change Principal Investigator" link below;
searching for the PI's name using the search feature;
clicking "Select" by the name of the Principal Investigator, then "Save Contact Information".
You will automatically be added as study personnel with edit authorization so you can continue editing the application. 
Please fill in any blank fields with the appropriate contact information (gray shaded fields are not editable). Required fields left blank will
be highlighted in pink after you click "Save".
To change home and work addresses, go to myUK and update using the Employee Self Service (ESS) portal. If name has changed,
the individual with the name change will need to submit a 'Name Change Form' to the Human Resources Benefits Office for entering
into SAP. The new name will need to be associated with the individual's Link Blue ID in SAP before the change is reflected in E-IRB.
Contact the HR Benefits Office for additional information.
Note: Principal Investigator (PI) role for E-IRB access
The PI is the individual holding primary responsibility on the research project with the following permissions on the E-IRB application:
1. Read; 
2. write/edit;
3. receive communications; and 
4. submit to the IRB (IR, CR, MR, Other Review*). 
Change  Principal Investigator:
First Name: Daniela
Room# &
Bldg: 789 S. Limestone
Room 241
Last Name: Moga
Speed
Sort#: 40356
Department: Pharmacy Practice &
Science
Degree:
 
PI’s
Employee/Student
ID#:
10921036
Rank: 
 
PI's Telephone #: 8593239682
Dept Code: 7K700
PI's e-mail
address: daniela.moga@uky.edu
PI's FAX
Number:
PI is R.N.
Yes
No
Trained: Yes
Date
Trained 5/6/2015
Do you, the PI, have a significant financial interest related to your responsibilities at the University of Kentucky (that requires
disclosure per the UK administrative regulation 7:2)?
Yes
No
Section 3 Page 1 of 2
43239


Section 3 Page 2 of 2
43239


RISK LEVEL
Indicate which of the categories listed below accurately describes this protocol
(Risk Level 1) Not greater than minimal risk
(Risk Level 2) Greater than minimal risk, but presenting the prospect of direct benefit to individuals subjects
(Risk Level 3) Greater then minimal risk, no prospect of direct benefit to individual subjects, but likely to yield generalizable
knowledge about the subject's disorder or condition.
(Risk Level 4) Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of subjects.
*“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of
themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological
examination or tests [45 CFR 46.102(i)]
Download UK's guidance document on assessing the research risk for additional information on risk [PDF] 
Section 4 Page 1 of 1
43239


SUBJECT DEMOGRAPHICS
Age level of human subjects: (i.e., 6 mths.; 2yrs., etc..) 65 yrs to N/A
Indicate the targeted/planned enrollment of the following members of
minority groups and their subpopulations
(Please note: The IRB will expect this information to be reported
at Continuation Review time):
Enter Numbers Only!
Ethnic Origin
#Male
#Female
American
Indian/Alaskan
Native:
Asian:
Black African
American:
Hispanic/Latino:
Native
Hawaiian/Pacific
Islander:
White/Caucasian:
Other or
Unknown:
If unknown, please
explain why:
Indicate the categories of subjects and controls to be included in the
study. Depending on the subject category applicable to your research
you may be required to complete additional forms. [Note, if the study
does not involve direct intervention or direct interaction with subjects,
(e.g., record-review research, outcomes registries), do not check mark
populations which the research does not specifically target. For
instance, a large record review of a diverse population may incidentally
include a prisoner or an international citizen, but, if the focus or intent of
the study has nothing to do with that status, you do not need to check
those category(ies).]
Check All That Apply (at least one item must be selected)
Children (individuals under
age 18)
Wards of the State (Children)
Emancipated Minors
Students
College of Medicine
Students
UK Medical Center
Residents or House Officers
Impaired Consent Capacity
Adults
ADDITIONAL INFORMATION:
Children
Emancipated Minors
Impaired Consent Capacity Adults:
Instructions; 
Link to required Form
Students as Subjects - Guidances:
- University of Kentucky Students
[PDF]
- College of Medicine Students
[requirement of OME] 
- K-12 [PDF]
0
0
1
1
4
5
1
1
0
0
38
39
Section 5 Page 1 of 3
43239


Pregnant
Women/Neonates/Fetal
Material
Prisoners
Non-English Speaking
International Citizens
Normal Volunteers
Military Personnel and/or
DoD Civilian Employees
Patients
Appalachian Population
UKMC Residents or House Officers
[see requirement of GME]
Non-English Speaking [see
instructions for recruitment and E-IRB
Research Description section on
same topic]
Prisoners
International Citizens [HTML] (DoD
SOP may apply [PDF])
Military Personnel and/or DoD Civilian
Employees (DoD SOP may apply
[PDF])
Section 5 Page 2 of 3
43239


Traumatic brain injury or acquired brain
injury
Severe depressive disorders or Bipolar
disorders
Schizophrenia or other mental disorders
that
involve serious cognitive disturbances
Stroke
Developmental disabilities
Degenerative dementias
CNS cancers and other cancers with
possible CNS involvement
Late stage Parkinson’s Disease
Late stage persistent substance
dependence
Ischemic heart disease
HIV/AIDS
COPD
Renal insufficiency
Diabetes
Autoimmune or inflammatory disorders
Chronic non-malignant pain disorders
Drug effects
Other acute medical crises
The next questions involve assessment of the study relative to potential recruitment of subjects with impaired consent capacity (or
likelihood).
Check this box if your study does not involve direct intervention or direct interaction with
subjects (e.g., record-review research, secondary data analysis). (you will not need to answer
the impaired consent capacity questions)
Does this study focus on adult subjects with any of the clinical conditions listed below
that present a high likelihood of impaired consent capacity or fluctuations in consent
capacity? (see examples below)
Yes
No
If Yes, go to the following link and complete and attach the indicated form unless you are filing for an exemption
certification: http://www.research.uky.edu/ori/ORIForms/FormT/Scale.asp
Examples of such conditions include:
Attachments
Section 5 Page 3 of 3
43239


INFORMED CONSENT/ASSENT PROCESS/WAIVER
You must check the box for at least one of the consent items and/or check mark one of the waivers, then if applicable attach the
corresponding document(s) as a PDF (if open to enrollment).
After making your selection(s) be sure to scroll to the bottom of this section and SAVE your work!
Consent/Assent Tips:
For your informed consent attachment(s), please download the most up-to-date version listed in "All Templates" under the
APPLICATION LINKS menu on the left, and revise to be in accord with your research project.
It is very important that only the documents you wish to have approved by the IRB are attached; DELETE OUTDATED
FILES -- previously approved versions will still be available in Protocol History.
If you have multiple consent documents, be sure to upload each individually (not all in a combined file).
Changes to consent documents (e.g., informed consent form, assent form, cover letter, etc...) should be reflected in a
'tracked changes' version and uploaded separately with the Document Type "Highlighted Changes".
Attachments that are assigned a Document Type to which an IRB approval stamp applies will be considered the
version(s) to be used for enrolling subjects once IRB approval has been issued. 
Document Types that do NOT get an IRB approval stamp are:
"Highlighted Changes",
"Phone Script", and
"Sponsor's Sample Consent Form".
Informed Consent Form (and/or Parental Permission Form)
Assent Form
Cover Letter (for survey/questionnaire research)
Phone Script (and/or Assent Script)
Informed Consent/HIPAA Combined Form
Debriefing and/or Permission to Use Data Form
Sponsor's sample consent form for Dept. of Health and Human Services (DHHS)-approved protocol
Additional Resources:
Issues and Sample Consent Language for Specimen Banking Studies [PDF]
Sample Research Repository Consent [WORD]
Instructions for Proposed Informed Consent Document [HTML]
Instructions for Proposed Assent Form [HTML]
Attachments
Attach Type
File Name
Informed ConsentHIPAA Combined Form INCREASE Form C V5.pdf
Request for Waiver of Informed Consent Process
If you are requesting IRB approval for waiver of the requirement for the informed consent process, or alteration of some or
all of the elements of informed consent (i.e. medical record review, deception research, or collection of biological
specimens), complete Section 1 and Section 2 below.
Note: The IRB does not approve waiver or alteration of the consent process for greater than minimal risk research, except
for planned emergency/acute care research as provided under FDA regulations. Contact ORI for regulations that apply to
single emergency use waiver or acute care research waiver (859-257-9428).
SECTION 1.
Check the appropriate item:
I am requesting waiver of the requirement for the informed consent process.
I am requesting alteration of the informed consent process.
Section 6 Page 1 of 3
43239


If you checked the box for this item, describe which elements of consent will be altered, and/or omitted, and justify the
alteration.
SECTION 2.
The IRB may consider your request provided that all of the following conditions apply to your research and are
appropriately justified. Explain in the space provided for each condition how it applies to your research.
a) The research involves no more than minimal risk to the subject.
b) The rights and welfare of subjects will not be adversely affected.
c) The research could not practicably be carried out without the requested waiver or alteration.
d) Whenever possible, the subjects or legally authorized representatives will be provided with additional pertinent
information after they have participated in the study.
Section 6 Page 2 of 3
43239


Request for Waiver of Documentation of Informed Consent Process
If you are requesting IRB approval for waiver of the requirement for documentation of informed consent (i.e. telephone
survey or mailed survey, internet research, or certain international research), your research activities must fit into one of two
regulatory options: 
1) The only record linking the participant and the research would be the consent document, and the principal risk would be
potential harm resulting from a breach of confidentiality (i.e., a study that involves participants who use illegal drugs). 
2) The research presents no more than minimal risk to the participant and involves no procedures for which written consent is
normally required outside of the research context (i.e. a cover letter on a survey, or a phone script). 
Select the option below that best fits your study, and explain in the space provided how your study meets the criteria for the
selected regulatory option. 
Note: The IRB cannot waive the requirement for documentation or alter the consent form for FDA-regulated research unless it
meets Option #2 below. FDA does not accept Option #1. 
Note: Even if a waiver of the requirement for documentation is approved by the IRB, participants must still be provided oral or
written (e.g., cover letter) information including all required and appropriate elements of consent so they have the knowledge
and opportunity to consider whether or not to participate. To help ensure required elements are included in your consent
document, please use the Cover Letter Template as a guide: English- [WORD] [RTF], Spanish- [WORD] [RTF] The cover
letter template was developed specifically for survey/questionnaire research; however, it may be useful as a guide for
developing a consent document for other types of research as well. 
Option 1
a) The only record linking the participant and the research would be the consent document:
b) The principal risk would be potential harm resulting from a breach of confidentiality (i.e., a study that involves
subjects who use illegal drugs).
Under this option, each participant must be asked whether (s)he wants to sign a consent form; if the participant
agrees to sign a consent form, only an IRB approved version should be used.
Option 2
a) The research presents no more than minimal risk to the participant:
b) Involves no procedures for which written consent is normally required outside of the research context (i.e. a cover
letter on a survey, or a phone script):
Section 6 Page 3 of 3
43239


STUDY PERSONNEL
Do you have study personnel who will be assisting with the research?
After selecting 'Yes' or 'No' you must save by hitting the 'Save Study Personnel Information' button. 
Yes
No
Manage Study Personnel
Identify other study personnel assisting in research project:
The individual listed as PI in the 'PI Contact Information' section should NOT be added to this section.
If the research is being completed to meet the requirements of a University of Kentucky academic program, the faculty advisor is also considered study personnel and should be
listed as such below.
Role: DP = Editor (individual can view, navigate, and edit the application for any review phase (IR, CR, MR) or 'Other Review", and submit Other Reviews on behalf of the PI.)
Role: SP = Reader (individual can view and navigate through the currently approved application only.)
To add an individual via the below feature, search for applicable personnel first, then click "select" by the listing for the person you want to add as study personnel to your protocol. For
each individual selected, be sure to specify responsibility in the project, whether authorized by the principal investigator to obtain informed consent, AND denote who should regularly
receive E-IRB notifications.
NOTE: Study personnel are required to receive human research protection (HSP) training before implementing any research procedures (e.g., CITI). For information
about mandatory training requirements for study personnel, visit UK’s FAQ's on Mandatory Training web page, or contact ORI at 859-257-9428. If you have
documentation of current HSP training other than that acquired through UK CITI, you may submit it to ORI (Jen.Hill@uky.edu) for credit.
Study personnel assisting in research project: 
Add Personnel
My Study
Personnel
Last
Name
First
Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
Removed?
Last
Updated
Recorded
Training
SFI
Details
Abner
Erin
Co-Investigator
SP
Y
N
PhD
 
Y
10/23/2015
N
12/18/2017
10025954
N
Details
Bardach
Shoshana
Co-Investigator
SP
Y
N
PhD
 
Y
01/16/2018
N
12/18/2017
10574656
N
Details
Beech
Brooke
Study Coordinator
DP
Y
Y
 
 
Y
07/31/2017
N
12/18/2017
12219565
N
Details
Bryant
Tammy
Data Collection
SP
N
N
PA-C
 
Y
06/01/2015
N
12/18/2017
00035014
N
Details
Burgess
David
Consultant/Advisor
DP
N
N
PharmD
 
Y
09/13/2016
N
01/11/2018
10925728
N
Details
Coy
Beth
Data Collection
SP
Y
N
ARNP
 
Y
07/02/2015
N
12/18/2017
00050716
N
Details
El
Khouli
Riham
Data
Analysis/Processing
SP
N
N
MD,
PhD
 
Y
08/16/2016
N
12/18/2017
12216127
N
Details
Jicha
Gregory
Co-Investigator
DP
Y
N
MD,
PhD
 
Y
03/10/2017
N
12/18/2017
00058463
N
Details
Lee
Kara
Consultant/Advisor
SP
N
N
PT,
DPT
 
Y
11/10/2015
N
01/09/2018
10172905
N
Details
Martinez
Ashley
Data
Analysis/Processing
SP
N
N
PharmD
 
Y
08/13/2016
N
12/18/2017
10987449
N
Details
Murphy
Richard
Co-Investigator
SP
Y
N
MBChB
 
Y
11/17/2016
N
12/18/2017
12002081
N
Details
Nichols
Heather
Project
Assistance/Support
SP
N
N
 
 
Y
07/19/2017
N
12/18/2017
00004144
N
Details
Rigsby
Dorinda
Data
Analysis/Processing
SP
N
N
 
 
Y
10/11/2017
N
12/18/2017
12058438
N
Details
Schmitt
Frederick
Co-Investigator
SP
N
N
PhD
 
Y
12/09/2015
N
12/18/2017
00003619
N
Details
Stevens
Hardin
Recruitment
SP
N
N
 
 
Y
05/17/2016
N
12/18/2017
00052953
N
Section 7 Page 1 of 1
43239


RESEARCH DESCRIPTION
**!!!PLEASE READ!!!** Known Issue: The below text boxes do not allow symbols, web addresses, or special characters
(characters on a standard keyboard should be ok). If something is entered that the text boxes don't allow, user will lose
unsaved information.
Workaround(s):
Save your work often to avoid losing data.
Use one of the attachment buttons in this section, or under the Additional Information section to include the
information with your application. During the document upload process, you will be able to provide a brief description
of the attachment.
Background: Provide an introduction and background information. Describe past experimental and/or clinical findings leading to the
formulation of your study. For research involving investigational drugs, describe the previously conducted animal and human studies.
You may reference grant application/sponsor’s relevant protocol pages and attach as an appendix in the E-IRB "Additional Information"
section. For research that involves FDA approved drugs or devices, describe the FDA approved uses of this drug/device in relation to
your protocol. Attach a copy of the approved labeling as a product package insert or from the Physician’s Desk Reference in the
applicable E-IRB "Study Drug" or "Study Device" section.
Alzheimer’s disease (AD) is one of the most important public health issues facing our society today. Approximately 5 million
Americans age 65 and older are currently living with AD,1 and this number will nearly triple by 2050.2 To forestall this impending
burden, the 2015 National Alzheimer’s Project Act (NAPA) report emphasized the need to identify effective prevention strategies that
can delay onset of symptomatic AD.3 The biological disease course of AD has been elucidated, consisting of a 10-20 year
prodromal period with buildup of amyloid plaques and neurofibrillary tangles, without overt symptomatic cognitive or functional
decline. The duration of this prodromal period is dependent on the rate of pathologic progression offset by compensatory
mechanisms, collectively referred to as cognitive reserve (Figure 1).4 While much emphasis has been placed on developing and
testing effective disease-modifying strategies targeting this asymptomatic preclinical phase of AD (pAD), little emphasis has been
placed on currently available strategies that target cognitive reserve during pAD. Previous research has validated the importance of
building and preserving cognitive reserve to prolong the asymptomatic phase of pAD.4-6 Comorbid medical conditions, psychosocial
stressors, and inappropriate medication use lower cognitive reserve leading to “unmasking” of dementia symptoms and hastening the
onset of the symptomatic phase of AD. Interventions designed to bolster cognitive reserve including aerobic exercise,7,8 complex
gameplay,9-11 diet,5,12-15 and, pharmacological interventions16,17 have shown promise but as yet have not been proven to delay
onset of AD.4 As depicted in Figure 1, pharmacy interventions to optimize medication use may delay the substantial financial and
societal impact of AD by maintaining elderly patients’ cognitive reserve. In our recent pilot Medication Therapy Management (MTM)
intervention trial we observed a 56% reduction in inappropriate anticholinergic drugs use in the elderly enrolled. These pilot data
document theMTM efficacy to change inappropriate medication use and potentially delay AD symptoms by maintaining patients’
cognitive reserve. Here we propose a randomized trial to expand this pilot and test MTM efficacy to reduce inappropriate medication
use, bolster cognitive reserve and ultimately delay symptomatic AD.
Objectives: List your research objectives. You may reference grant application/sponsor’s relevant protocol pages and attach as an
appendix in the E-IRB "Additional Information" section.
Specific Aim 1: Conduct a 12-month, randomized, placebo-controlled trial to evaluate the impact of our patient-centered, pharmacist-
physician team MTM intervention in reducing unnecessary and inappropriate medication use in community-dwelling, elderly, non-
demented subjects. Our team will specifically target the Beers 2015 list of inappropriate medications for those 65 years and older,
and implement individualized, patient-centered alternative management strategies. Primary outcome measures will include pre- to
post- intervention measures of: (1) use of inappropriate medications as measured by the Medication Appropriateness Index (MAI); 2)
Cognitive Reserve Change Score (CRCS), defined as the difference in the scopolamine- challenged vs unchallenged measures on
the neurocognitive score (defined below). Specific Aim 2: Evaluate the impact of preclinical amyloid burden on cognitive reserve
deficits and decline (measured as CRCS) to evaluate efficacy of delaying symptomatic disease progression in pAD. Baseline
determination of total brain relative standardized uptake values for amyloid ß- positron emission tomography will be used to examine
the relative impact of preclinical AD pathology on CRCS at baseline and over time in the placebo group, as well as the interplay of
pAD pathology with inappropriate medication use at baseline and optimization of medication use after one year of MTM intervention.
Objectives: 1) Examine the effectiveness of the MTM intervention in reducing inappropriate medication use over the study period as
assessed by the MAI (Aim 1). 2) Investigate the effects of baseline Aß-PET and medication appropriateness index (MAI) 35 on
cognitive reserve, operationalized as the CRCS = scopolamine challenged test performance z score - unchallenged cognitive test
performance z score (Aim 1 and 2). 3) Investigate the effects of MTM and changes in MAI on CRCS in subjects that are Aß-PET
positive or negative over the one-year study period (Aim 1 and 2).
Study Design: Describe the study design (e.g., single/double blind, parallel, crossover, etc.). Indicate whether or not the subjects will
receive placebo medication at some point in the research procedures. Also, indicate whether or not the subjects will be randomized in
this study. You may reference sponsor’s protocol pages and attach as an appendix in the E-IRB "Additional Information" section.
(Including the study design table from a sponsor’s protocol is helpful to IRB members.)
Community-Based Participatory Research: If you are conducting community-based participatory research (CBPR), describe
strategies for involvement of community members in the design and implementation of the study, and dissemination of results from the
Section 8 Page 1 of 10
43239


study.
Research Repositories: If the purpose of this submission is to establish a research repository describe the repository design and
operating procedures. For relevant information to include, see question 22 of the UK IRB “Frequently Asked Questions (FAQs) on the
Return of Research Results or Incidental Research Findings” [PDF].
This is a 12-month, parallel arm, placebo-controlled study to be conducted at the University of Kentucky. 90 non-demented subjects
with varying levels of Aß-PET positivity (estimated that 30 will meet threshold criteria for pAD) will be randomly assigned to treatment
with the MTM intervention or placebo. Those assigned in the intervention arm might have medication changes recommended by the
research team. A letter describing all the proposed changes will be sent to the participant’s primary care physician (PCP). These
changes will be recommended, but not forced on the participant and their PCP. The participant and their PCP will have final decision
on accepting or rejecting the proposed changes in the medication plan. All subjects will undergo cognitive testing under both
scopolamine challenged and unchallenged conditions within 4 weeks, as well as physical and neurologic exam, and Aß-PET scan at
baseline. Cognitive testing under both scopolamine challenged and unchallenged conditions within 4 weeks, as well as physical and
neurologic exam will be performed at study completion. Randomization will be stratified by Aß positivity on PET scans. If unbalanced
between groups after randomization, age, gender, education, NART, and number of targeted inappropriate medications using Beers
2015 Criteria will be included in the analyses.
Attachments
Back to Top
Study Population: Describe the characteristics of the subject population, such as anticipated number, age range, gender, ethnic
background and health status. Identify the criteria for inclusion and exclusion. Explain the rationale for the use of special classes such
as fetuses, pregnant women, children, institutionalized, adults with impaired consent capacity, prisoners or others who are likely to be
vulnerable. If women or minorities are included, please address how the inclusion of women and members of minority groups and their
subpopulations will help you meet your scientific objectives. Exclusion of these groups requires clear and compelling rationale that
shows inclusion is inappropriate with respect to the health of the subjects or that inclusion is inappropriate for the purpose of the study.
Cost is not an acceptable reason for exclusion except when the study would duplicate data from other sources. Women of
childbearing potential should not be excluded routinely from participation in clinical research. 
Provide the following information: 
• A description of the subject selection criteria and rationale for selection in terms of the scientific objectives and proposed study
design;
• A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group;
• The proposed dates of enrollment (beginning and end);
• The proposed sample composition of subjects.
You may reference grant application/sponsor’s relevant protocol pages and attach as an appendix using the below attachment button.
We plan to enroll 90 participants. Eligibility and inclusion/exclusion criteria have been selected on the basis of efficacy endpoints and
safety concerns and contraindications to scopolamine therapy or PET scanning to minimize the potential for adverse events.
Recognized contraindications and medical conditions preventing the use of scopolamine patches or those requiring dosage
adjustments will be screened for and subjects excluded from the protocol. Inclusion Criteria: 1. 65 years and older 2. Non-demented
3. No previous reaction or contraindication to scopolamine patch, or medical condition warranting dose adjustment in scopolamine
including but not limited to: open angle glaucoma, gastrointestinal or urinary outlet obstructions, seizures, or psychosis. 4. No
contraindications to Aß-PET scan including hypersensitivity to PET ligand or radiation exposures in the past year that would exceed
the acceptable safe annual exposure in combination with the Aß PET 5. Medically stable and able to complete all study activities, as
determined by the investigator 6. Reporting at least one potentially inappropriate medication as listed in the Beers 2015 criteria 7.
Living in the community 8. Able to identify a study partner who will drive the participant to and from the scopolamine-challenged visits.
9. Willing to participate in this intervention study. Exclusion Criteria: 1. Allergy or other know intolerance to scopolamine patches 2.
Narrow-angle glaucoma 3. Difficulty swallowing 4. Stomach or bowel problems (e.g., blockage, muscle weakness, ulcerative colitis) 5.
Bleeding 6. Myasthenia gravis 7. Blockage of the urinary tract. 8. Seizures 9. Psychosis
Attachments
Subject Recruitment Methods & Privacy: Describe plans for the identification and recruitment of subjects, including how the
population will be identified, and how initial contact will be made with potential subjects by those having legitimate access to the
subjects' identity and the subjects' information. Describe the setting in which an individual will be interacting with an investigator. If
applicable, describe proposed outreach programs for recruiting women and minorities as participants in clinical research.
Please note: Based upon both legal and ethical concerns, the UK Medical Institutional Review Board (IRB) will not approve finder’s
fees for research studies. 
Subjects will be recruited using the following avenues: a. The existing normal control group (500 participants) followed by the UKADC
under IRB#88-00102. No advertising will be performed. We will send out a letter to subjects in the UK ADC normal control cohort
alerting them to the study and asking them to contact us if interested in participating (attached as appendix). b. Voter registry list
available through IRB# 79-01185 (2134 community elderly). No advertising will be performed. We will send out a letter to subjects in
Section 8 Page 2 of 10
43239


the UK ADC normal control cohort alerting them to the study and asking them to contact us if interested in participating (attached as
appendix). c. Use of UK IRB-approved media outlets and exposure, physicians engaged in the memory disorders clinic, community
physician or personal referrals. We will used an IRB approved flyer (attached as appendix).
Back to Top
Advertising: Specify if any advertising will be performed. If yes, please see “Advertisements - Application Instructions” for
instructions on attaching copies of the information to be used in flyers or advertisements. Advertisements must be reviewed and
approved by the IRB prior to use. For additional details, see topic "Recruitment" or "Advertising" on ORI's IRB Survival Handbook web
page for the PI Guide to Identification and Recruitment of Human Subjects for Research [D7.0000] document [PDF]. If you will be
recruiting subjects via advertising at non-UK owned or operated sites, you should include a copy of written permission from that site to
place the advertisement in their facilities. 
Below is a list of advertising venues we may employ during this study. We will ensure that any advertisement is reviewed and
approved by the IRB prior to it being implemented. We will follow a social media site’s terms of use for any posted recruitment
efforts. Print advertisements: The study may recruit subjects through flyers, brochures, posters, Research Spotlights, bookmarks
placed on campus and in the surrounding community (region) including but not limited to the UK Medical center, UK Clinics, Good
Samaritan Hospital, student center, UHS, the 5 UK Center for Clinical and Translational Research wall mounts, Cardinal Hill, monitor
screens, and area facilities and businesses. Paid print advertising: Subjects may be recruited through paid print advertisements:
brochures, magazines, newspaper (e.g., Herald Leader, Bluegrass Area, Courier Journal, Cincinnati Enquirer, Health & Wellness,
Chevy Chaser, Hamburg Journal, Business Lexington, or others surrounding area or region), radio (e.g., Sirius, Clear Channel,
Cumulus, LM Communications, Public Radio), television spots, or scrolling information on community stations. Recruitment ads may
also appear on billboards, Lextran buses, taxicabs, and other transportation methods. Internet and Social Media: This study may be
advertised on internet webpages (e.g., UKclinicalresearch.com, ResearchMatch.org, CenterWatch, CISCRP, Craig’s list,
Lexington.MD, UK, CCTS); Social Media: e.g., UK_CCTS Facebook, UK_CCTS Twitter, or department research website,etc.). If
advertised on UKClinicalresearch.com, the study flyer could include an option for interested individuals to enter and submit their
contact information so that a research coordinator can contact them about participating. This study may also go out on email
distributions list servs, e.g., the CCTS list serv. Research Participant Registries: Potential participants may be identified from registry
databases. (e.g.: Vanderbilt University ResearchMatch.org, Women’s Health Registry, Sanders Brown Center on Aging, Infectious
Disease, Dentistry, Markey Cancer Center). Databases may also be owned and operated by non-UK research groups (e.g.,
Partnering groups and Health-related Associations, Recruitment Firms, Private Health Organizations: examples, MyTrialsFinder,
PatientsLikeMe.com, etc.) UK Public Relations (College/Dept. PR personnel) and UK HealthCare venues: Articles and interviews
about the researchers and research study may be promoted via UKNow, health columns in the Lexington Herald Leader or Kentucky
living, and other media outlets. The study may also be promoted through UKPR and UHC social media webpages (Facebook and UK
Twitter), and these posts may also use "boosts" to reach a larger audience. Research and study-related articles published on UKNow
may contain standard language directing interested individuals on where to read more about research and current studies: You can
make a difference through participating in research and discovery. To find more information, including a list of current studies at UK
and access to studies nationwide, you can visit UKclinicalresearch.com, call 859.257.7856, or join ResearchMatch.org. UKPR and
UK HealthCare marketing may create videos to promote research, researchers and their studies to local, regional and national media
venues and on internal hospital monitors. UK HealthCare will place study recruitment flyers on their internal and external racks (e.g.,
UK pharmacies, clinics, UK Libraries and Lexington Libraries). Participants may be recruited using newsletters, such as In the Loop,
Health Matters, Making a difference, and external news letters. The study may also be advertised through UKPR and UKHC outreach
activities. UKHC and CCTS have booths at many events, and researchers and coordinators are invited to attend any events that
pertain to their study populations. Researchers may participate in radio or TV interviews. General information about their research will
be discussed and a phone number or website url for more information will be provided. Consenting members of the research team
and/or consenting participants may be interviewed about the study for print, radio, or video which may be distributed via the
aforementioned activities. ResearchMatch.org will be utilized as a recruitment tool for this protocol. ResearchMatch.org is a national
electronic, web-based recruitment tool that was created through the Clinical & Translational Science Awards Consortium in 2009 and
is maintained at Vanderbilt University as an IRB-approved data repository (see IRB#090207)." All interested participants that meet
inclusion criteria will be invited for a screening visit. Doctors Jicha, Murphy or Beth Coy. ARNP will determine if potential subjects
meet inclusion criteria. At this visit, the subject will receive an explanation of the purpose of the study, the nature of the participant’s
involvement, and will be asked to provide written informed consent if they remain interested in participating.
Attachments
Attach Type
File Name
Advertising
INCREASE_flyer_Version_3.pdf
Advertising
INCREASE Recruitment Letter Version 5 CLEAN.pdf
Section 8 Page 3 of 10
43239


Informed Consent Process: Describe the consent/assent procedures to be followed, the circumstances under which consent will be
sought and obtained, the timing of obtaining informed consent, whether there is any waiting period between informing the prospective
subject and obtaining consent, who will seek consent (Note: all individuals authorized to obtain informed consent should be designated
as such in the E-IRB "Study Personnel" section of this application), steps taken to minimize the possibility of coercion or undue
influence, the method used for documenting consent, and if applicable who is authorized to provide permission or consent on behalf
of the subject. Describe, if applicable, use of specific instruments or techniques to assess and confirm potential subjects’
understanding of the nature of the elements of informed consent (i.e., research involving adult subjects with impaired consent capacity)
and/or a description of other written materials that will be provided to participants or legally authorized representatives. If you have a
script, please prepare it using the informed consent template as a guide, and submit it on a separate page. For additional information,
see the "Informed Consent Standard Operating Procedures (SOPs)" [PDF].
Informed Consent for Research Involving Emancipated Individuals
If you plan to enroll some or all prospective subjects as emancipated, consult with UK legal counsel when preparing the IRB
application and prior to submitting the application to the IRB. Include legal counsel’s recommendations (legal counsel’s
recommendations may be attached in the E-IRB "Additional Information" section as a separate document, if necessary). For a
complete definition of emancipated minors, see the section on Emancipated Individuals in the Informed Consent SOP [PDF].
Informed Consent for Research Involving Non-English Speaking Subjects
If you are recruiting non-English speaking subjects, the method by which consent is obtained should be in language in which the
subject is proficient. Describe the process for obtaining informed consent from prospective subjects in their respective language (or
the legally authorized representative’s respective language). In order to ensure that individuals are appropriately informed about the
study when English is their second-language, describe a plan for evaluating the level of English comprehension, and the threshold for
providing a translation, or explain why an evaluation would not be necessary. For additional information on inclusion of non-English
speaking subjects, or subjects from a foreign culture, see Instructions for Recruiting Non-English Speaking Participants or Participants
from a Foreign Culture.
Research Repositories
If the purpose of this submission is to establish a research repository describe the informed consent process. For guidance regarding
consent issues, process approaches, and sample language see the “University of Kentucky Issues to be Addressed and Sample
Consent Language for Tissue/Specimen Repositories or Individual Studies Banking Material for Future Use” [PDF].
Prior to entering the study, the risks and benefits of participating will be explained to the participant by a member of the study team
authorized to obtain informed consent. A signed and dated informed consent form will be retained by the investigator. The study
participant will receive a copy of the informed consent form.
Back to Top
Research Procedures: Describe the research procedures that will be followed. Identify all procedures that will be carried out with
each group of subjects. Differentiate between procedures that involve standard/routine clinical care and those that will be performed
specifically for this research project.
Screening Visit (Week -5 ± 2): Subject appropriateness and safety for the study will be assessed with thorough review of medical
history, medication review, physical/neurological exam, vital signs, and ECG. SF-36 will assess pre- study perceived health status.
Lifestyle Factor Questionnaire will further assess health history and current health status. A Baseline Questionnaire will assess
motivation for participating and understanding of medications. Aß-PET will be performed to allow stratification at baseline.
Approximately 4 hours. Baseline and EOS visit (Scopolamine-challenge; week -4 ± 1 & week 52 ± 1): Subject will apply scopolamine
patch at ~8pm the night before this visit to ensure adequate plasma levels of scopolamine. Study partner will drive subject to and
from appointment. Medical history and medication review will be performed to ensure no changes have occurred since prior visit. Vital
signs will be obtained. Cognitive testing including TMTB, MoCA, CVLT will be performed. Following cognitive testing, subject will
remove scopolamine patch. Baseline and EOS visit (Non-challenge; week 0 ± 1 & week 56 ± 1): Medical history and medication
review will be performed to ensure no changes have occurred since prior visit. Vital signs will be obtained. Cognitive testing including
TMTB, MoCA, and CVLT will be performed. MTM intervention vs. placebo distribution of educational materials on PIM use will be
performed. SF-36, Lifestyle Factors Questionnaire, and End of Study (EOS) Questionnaire will be administered at the EOS visit to
assess changes in health status. Month 3 & 9 visits (week 13 ± 1 & week 39 ± 1): Telephone check to screen for adverse effects,
update medical history and medication review. Month 6 visit (week 26 ± 1): Medical history and medication review will be performed to
ensure no changes have occurred since prior visit. Vital signs will be obtained MTM intervention vs. placebo distribution of
educational materials on PIM use will be performed. Randomization: For randomization, subjects will be stratified by Aß positivity on
PET scans; if age, gender, education, NART scores, and the number of targeted inappropriate medications using 2015 Beers
Criteria are unbalanced between groups after randomization, they will be included in the analyses. Blinding: As the intervention is
educational in nature, complete blinding of intervention is not possible. However, we will take the following steps in order to minimize
potential bias and achieve the maximum level of blinding possible by this design: 1. When reviewing the medication list prior to the
intervention, the coordinator, study pharmacist, and physician will be unaware of the group allocation. 2. Data analysis will be blinded
to the intervention.
Attachments
Data Collection: List the data or attach a list of the data to be collected about or from each subject (e.g. interview script, survey tool,
data collection form for existing data).
Section 8 Page 4 of 10
43239


If the research includes survey or interview procedures, the questionnaire, interview questions or assessment scales should be
included in the application (use attachment button below).
The data collection instrument(s) can be submitted with your application in draft form with the understanding that the final copy will be
submitted to the IRB for approval prior to use (submit final version to the IRB for review as a modification request if initial IRB approval
was issued while the data collection instrument was in draft form).
See attached data collection schedule table and surveys.
Attachments
Attach Type
File Name
DataCollection
INCREASE Study Procedures.pdf
DataCollection
Lifestyles Survey_V6.0_Initial Packet.docx
DataCollection
Lifestyles Survey_Follow-Up.docx
DataCollection
16 - SF-36.pdf
DataCollection
17 - Baseline Questionnaire.docx
DataCollection
11 - EOS Questionnaire.docx
Resources: Describe what resources/facilities are available to perform the research (i.e., staff, space, equipment). Such resources
may include a) staffing and personnel, in terms of availability, number, expertise, and experience; b) psychological, social, or medical
services, including counseling or social support services that may be required because of research participation; c) psychological,
social, or medical monitoring, ancillary care, equipment needed to protect subjects; d) resources for subject communication, such as
language translation services, and e) computer or other technological resources, mobile or otherwise, required or created during the
conduct of the research. Please note: Some mobile apps may be considered mobile medical devices under FDA regulations (see
FDA Guidance). Proximity or availability of other resources should also be taken into consideration, for example, the proximity of an
emergency facility for care of subject injury, or availability of psychological support after participation. 
Research activities conducted at performance sites that are not owned or operated by the University of Kentucky, at sites that are
geographically separate from UK, or at sites that do not fall under the UK IRB’s authority, are subject to special procedures for
coordination of research review. Additional information is required (see ORI's Off-Site Research web page); supportive documentation
can be attached in the E-IRB "Additional Information" section. Provide a written description of the role of the non-UK site(s) or non-UK
personnel who will be participating in your research. The other site may need to complete its own IRB review, or a cooperative review
arrangement may need to be established. Contact the Office of Research Integrity at (859) 257-9428 if you have questions about the
participation of non-UK sites/personnel.
If the University of Kentucky is the lead site in a multi-site study, or the UK investigator is the lead investigator, describe the plan for
managing the reporting of unanticipated problems, noncompliance and submission of protocol modifications and interim results from
the non-UK sites.
Patient enrollment, medication and medical history data collection, and cognitive evaluations will be conducted in the UK-Alzheimer’s
Disease Center (ADC) Clinical Core facilities (1030 South Broadway). The participants will be followed by Dr. Daniela Moga and her
research team which includes physicians (Dr. Greg Jicha will serve as primary medical contact), pharmacists, and postdoctoral
assistants during the study. Dr. Lynne Eckmann is a local non-UK affiliated pharmacist with extensive experience in providing
medication therapy management to elderly patients with multiple comorbid conditions. She is not affiliated with a company that has an
IRB, and she has signed an Individual Investigator Agreement with the University of Kentucky. Though the likelihood of the participant
having an acute untoward reaction during the study visits is very small, emergency medical equipment, medications and supplies will
be at the physician's disposal should this need arise. PET scanning will take place at the UK PET facilities on Campus.
Potential Risks: Describe any potential risks or likely adverse effects of the drugs, biologics, devices or procedures subjects may
encounter while in the study. Please describe any physical, psychological, social, legal or other risks and assess their likelihood and
seriousness.
Physical and neurological examinations, neuropsychological tests, and social and medical histories will be collected: Minimal
physical, psychological, social, legal and other risks are associated with these procedures. However, the availability of health
professionals, including an experienced dementia care clinical coordinator/neuropsychologist and the ready availability of two on-site
social workers to work with patients and families throughout the clinical and research process further minimizes possible risks. Such
risks by category include: • Memory and thinking testing: anxiety, stress or boredom • Social Risks: Breach of confidentiality could
impact insurability, employability, reproduction plans, family relationships, immigration status, paternity suits, or result in stigmatization.
• Psychological Risks: If information is disclosed, anxiety and stress may result from the impact of learning results. Additionally, the
risk of psychological stress may exist for family members as well. Scopolamine challenge: Specific adverse events of concern
regarding the scopolamine challenge include those associated with the use of anticholinergics in the elderly, including disorientation,
confusion, and dizziness. Prior to baseline scopolamine challenge, medical history, concomitant medications, physical and neurologic
exams, ECG will be performed to evaluate for potential unforeseen medical risks. The study physician will be responsible for
determining if the subject is acceptable for randomization and scopolamine challenge. Subjects will be advised that the scopolamine
patch may cause such effects and that they should avoid driving and operating heavy or otherwise dangerous machinery until off the
patch for at least 24 hours. Study physicians are available 24-7 should any participant experience adverse side effects. Subjects are
advised to have a study partner to drive and accompany them to and from the two study visits during which the scopolamine-
challenge will occur. Aß-PET: Florbetapir F 18 Injection is approved by the United States Food and Drug Administration (FDA) to
estimate amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease
Section 8 Page 5 of 10
43239


and other causes of cognitive decline. Florbetapir (F 18) is an imaging agent that includes a small amount of radioactivity (radiation)
necessary to create the PET scan images. The dose used in this study is below the level that has been shown to have an effect on
the body. The total amount of radiation from the florbetapir (F 18) PET scan and PET scanner machine, is slightly more than a patient
receives from a routine CT scan and about 3 to 6 times as much as the average person receives per year from natural and man-
made radiation. Exposure to large amounts of radiation increases the risk of developing cancer. The most common side effect in
completed studies with Florbetapir involving 555 subjects was headache. Additional uncommon side effects reported were nausea,
dysgeusia, flushing, pruritus, urticaria, and infusion site rash. Musculoskeletal (muscle and bone) pain in the neck, shoulder, and back,
fatigue, anxiety, claustrophobia, insomnia, dizziness, chills/feeling cold, and hypertension were also reported. There were other side
effects, but none that occurred in more than one subject in the research studies.
Back to Top
Safety Precautions: Describe the procedures for protecting against or minimizing any potential risks, including risks of breach of
confidentiality or invasion of privacy. Where appropriate, discuss provisions for ensuring necessary medical or professional
intervention in the event of adverse events, or unanticipated problems involving subjects. Also, where appropriate, describe the
provisions for monitoring the data collected to ensure the safety of subjects. If vulnerable populations other than adults with impaired
consent capacity are to be recruited, describe additional safeguards for protecting the subjects’ rights and welfare.
a. Recruitment and Informed Consent: The study investigators will obtain Institutional Review Board (IRB) Approval for all proposed
activities and IRB assurances have been filed with the Department of Health and Human Services. b. Assessment of Capacity: Our
protocol includes capacity evaluation for all research subjects irrespective of cognitive status to ensure willingness to participate in
the research which is performed by our trained licensed clinicians and recorded in our UK-specific research data collection for the
proposed project for all subjects recruited from the ADC cohort. Subjects recruited from external sources including the Voter
registration list, have not previously undergone capacity assessment. As such, we will require the mandatory use of the University of
California, San Diego Brief Assessment of Capacity to Consent (UBACC) by the consenting staff member for all subjects enrolled.
Subjects lacking capacity, will not be enrolled in the study, as their understanding and compliance with the medication management
intervention is a critical part of the current study. c. Biobanking of Aß-PET: Biobanking of PET images will be required of all research
subjects. This provides for sharing of de-identified images (as well as phenotypic) data with any investigators for the purpose of
advancing research in the area of aging and dementia. This will be broadly defined in our consent to allow maximal use of these
samples to further research in the field. The biobanking protocol will have no pre-specified time limit and images will be retained
indefinitely unless they are withdrawn at the request of the study participant. d. Protections against Risk: The confidentiality of our
research subjects will continue to receive high priority. Hard copies of data will be maintained in locked files with access only to key
individuals. All information collected on human subjects will be stored in the ADC master database with access to this data strictly
monitored. The research part of the database is referenced only by subject code numbers. We appreciate the confidence that our
subjects place in us through their participation in our programs. Guaranteeing the privacy of subject records will continue to be an
essential function for all personnel involved with this data. Procedures utilized as a part of our research, e.g., cognitive testing, should
not require medical or professional intervention. The Inclusion/Exclusion criteria is specifically designed to minimize risk for the
scopolamine challenge and Aß-PET scan. We do not anticipate SAEs in relation to the current protocol or interventions. However, our
physicians and professional staff will be available if a problem is identified. e. Staff Qualifications, Training, and Certifications in
Human Subjects Research: We will keep private all research records that identify participants to the extent allowed by law. Information
obtained from the participant will be combined with information from other people taking part in the study. When we write about the
study to share it with other researchers, we will write about the combined information we have gathered. The participant will not be
personally identified in these written materials. Provisions to guard against the potential risks and discomforts discussed in section 9
are as follows: Every precaution to prevent a direct study injury will be taken by medical personnel and the investigators. The research
participant will be followed by physicians, physician assistants, registered nurses, pharmacists, and other research staff members for
the duration of the individual’s participation in the research study. Routine care will be provided by the hospital staff. Emergency
medical equipment, medications and supplies will be at the physician's disposal should the participants have an acute untoward
reaction. The participants will be monitored for clinical adverse experiences throughout study therapy. Throughout the study, all
adverse events will be monitored and recorded.
Benefit vs. Risk: Describe potential benefits to the subject(s); include potential benefits to society and/or general knowledge to be
gained. Describe why the risks to subjects are reasonable in relation to the anticipated benefit(s) to subjects and in relation to the
importance of the knowledge that may reasonably be expected to result. If you are using vulnerable subjects (e.g., impaired consent
capacity, pregnant women, etc…), justify their inclusion by describing the potential benefits of the research in comparison to the
subjects’ vulnerability and the risks to them.  For information about inclusion of certain vulnerable populations, see the IRB/ORI
Standard Operating Procedure for Protection of Vulnerable Subjects [C3.0100] [PDF].
Our research subjects will receive regular medical and cognitive assessments in addition to the interdisciplinary medication
management intervention that is specifically designed to ensure maximal quality of care for all research participants. In addition, our
research subjects are traditionally altruistic individuals who want to aid in the advancement of knowledge related to AD. Many have
had family members or friends affected by AD and appreciate the need for additional research. These benefits clearly outweigh the
greater than minimal risks of the protocol and procedures in the proposed application.
Available Alternative Treatment(s): Describe alternative treatments and procedures that might be advantageous to the subjects,
should they choose not to participate in the study. This should include a discussion of the current standard of care treatment(s).
Participants who do not want to take part in the study could review their medications with their physicians and pharmacist and have
them adjusted accordingly outside the protocol.
Section 8 Page 6 of 10
43239


Back to Top
Research Materials, Records and Privacy: Identify the sources of research material obtained from individually identifiable living
human subjects. Indicate what information (specimens, records, data, genetic information, etc.) will be recorded and whether use will
be made of existing specimens, records or data. Explain why this information is needed to conduct the study.
Return of Research Results or Incidental Findings (if applicable):
If research has the potential to identify individual results or discover incidental findings that could affect the health of a subject,
describe plans to assess, manage, and if applicable disclose findings with individual subjects or provide justification for not disclosing.
For IRB expectations, refer to the UK IRB “Frequently Asked Questions (FAQs) on the Return of Research Results or Incidental
Research Findings” [PDF].
The investigative team maintains the right to keep, preserve, use and dispose of the findings of this investigation in accordance with
University of Kentucky IRB and Records Management guidelines. Data and study records will be maintained for six years after the
completion of this study. Officials of the University of Kentucky maintain the right to inspect the records of the study at any time.
Investigational records from this study will be maintained in a confidential manner; participant names will not be associated with any
published results.
Confidentiality: Specify where the data/specimens will be stored and how the researcher will protect both the data and/or specimens
with respect to privacy and confidentiality. Address physical security measures (e.g., locked facility, limited access); data security (e.g.,
password-protection, data encryption); safeguards to protect identifiable research information (e.g., coding, links, certificate of
confidentiality); and procedures employed when sharing material or data, (e.g., honest broker (if applicable), written agreement with
recipient not to re-identify). If you plan to procure, store, and/or share material (tissue/specimens/data) expressly for use in current or
future research, describe measures that you will take to secure and safeguard confidentiality and privacy.
Provide a time table for destroying the data/specimens and identify how they will be destroyed, or provide rationale for perpetual
maintenance [Note: The investigator is responsible for retaining the signed consent and assent documents and IRB research records
for at least six years after study closure as outlined in the Study Closure SOP [PDF]. If the research falls under the authority of FDA or
other regulatory agency, the investigator is responsible for retaining the signed documents and IRB records for the period specified if
longer than six years after completion of the study]. For multi-site studies, the PI consults the study sponsor regarding retention
requirements, but must maintain records for a minimum of six years after study closure. Also, specify who will access the identified
data/specimens, and why they need access. If applicable, describe what measures will be taken to ensure that subject identifiers are
not given to the investigator. If applicable, describe procedures for sharing data/specimens with entities not affiliated with UK. 
NIH-funded genomic research: The National Institutes of Health (NIH) Genomic Data Sharing (GDS) Policy sets forth
expectations that ensure the broad and responsible sharing of genomic research data consistent with the informed consent
of study participants from which the data was obtained. If you are submitting genomic data to an NIH data repository,
describe your NIH data sharing plan.
Please note: The IRB expects researchers to access the minimal amount of identifiers to conduct the study and comply with
applicable HIPAA and Family Educational Rights and Privacy Act (FERPA) requirements. If data are going to be collected, transmitted,
and/or stored electronically, for appropriate procedures please refer to the guidance document "Confidentiality and Data Security
Guidelines for Electronic Data" [PDF].
Also please note that storage of data on cloud services may not be appropriate and is subject to applicable university policies
regarding the use of cloud services. If deemed too sensitive or inappropriate to be stored or collected using cloud services, the IRB
may require an alternate method of data storage in accordance with applicable university policies and the electronic data security
guidance document referenced above.
If a research protocol involves the creation and/or use of a computer program or application, mobile or otherwise, please specify
whether the program/application is being developed by a commercial software developer or the research team and provide any
relevant information regarding the security and encryption standards used, how data is stored and/or transmitted to the research team,
what information about the subjects the program/application will collect, etc. The IRB may require software programs created or used
for research purposes be examined by a consultant with appropriate Internet technology expertise to ensure subject privacy and data
are appropriate protected.
Back to Top
We will make every effort to keep confidential all research records that identify the subject to the extent allowed by law. We will make
every effort to prevent anyone who is not on the research team from knowing that the participant gave us information, or what that
information is. Participant information will be combined with information from other people taking part in the study. When we write
about the study to share it with other researchers, we will write about the combined information we have gathered. Participants will not
be personally identified in these written materials. We may publish the results of this study; however, we will keep the participant’s
name and other identifying information private. Electronic data with PHI are stored in the University of Kentucky’s medical database
that has limited medical personnel access, is password protected, and monitored for abnormal activity. Incidental materials containing
subject identifiers will be shredded or incinerated. Participant consent forms and demographic sheets including each participant’s
name, date of birth, and contact information along with basic demographic information and a unique study-specific participant
identification number (PIN) will be stored in a locked cabinets in the College of Pharmacy, 241 BPC or at Sander-Brown Center on
Aging, 1030 South Broadway, Suite #5, Lexington, KY. There are some circumstances in which we may have to show participant
information to other people. For example, the law may require us to show their information to a court or to tell authorities if they report
Section 8 Page 7 of 10
43239


information about a child being abused or if they pose a danger to themselves or someone else. Officials of the University of
Kentucky, the Sanders-Brown Center on Aging, Center for Clinical and Translational Science and their agents/representatives, and the
College of Pharmacy may look at or copy pertinent portions of records that identify our subject.
Back to Top
Payment: Describe the incentives (e.g., inducements) being offered to subjects for their time during participation in the research
study. If monetary compensation is offered, indicate how much the subjects will be paid and describe the terms and schedule of
payment. (It is IRB policy that provision should be made for providing partial payment to subjects who withdraw before the completion
of the research. Monetary payments should be prorated or paid in full.)
Participants could receive up to $200 for taking part in the study. Participants will be compensated $100 for each scopolamine
challenge visit, to allow for transportation or lost wages costs for study partners that provide such service. Participant payment will be
in the form of a $100.00 Visa card which will be issued at the completion of the visit.
Costs to Subjects: Describe any costs for care associated with research (including a breakdown of standard of care procedures
versus research procedures), costs of test drugs or devices, and research procedure costs that are the subject’s responsibility as a
consequence of participating in the research. Describe any offer for reimbursement of costs by the sponsor for research related injury
care.
There will be no cost to participate in this study. All tests and procedure required by the protocol are being done for the sole purpose
of the study. Parking during study visits will be provided at no cost. The participant and/or their insurance company, Medicare or
Medicaid will be responsible for the costs of all care and treatment they receive during this study that they would normally receive for
their condition. These are costs that are considered medically reasonable and necessary and will be part of the care they receive if
they do not take part in this study. The University of Kentucky does not have funds set aside to pay for the cost of any care or
treatment that might be necessary because a participant gets hurt or sick while taking part in this study. Also, the University of
Kentucky will not pay for any wages lost if a participant is harmed by this study. The medical costs related to care and treatment
because of research related harm will be the subject’s responsibility or may be paid by their insurer if they are insured by a health
insurance company. Subjects will be instructed to ask their insurer if they have any questions regarding their insurer’s willingness to
pay under these circumstances. If the participant is covered by Medicare or Medicaid they will be instructed to contact Medicare by
calling 1-800-Medicare (1- 800-633-4227) or Medicaid by calling 1-800-635-2570. A co-payment/deductible may be required by their
insurer or Medicare/Medicaid even if the insurer or Medicare/Medicaid has agreed to pay the costs. The amount of this co-
payment/deductible may be substantial. In this study, the study doctors and pharmacists may recommend changes to the participant’s
medications that could potentially result in higher costs to them (deductible or other out-of-pocket expenses). The study team will
work with the participant to find the lowest cost alternatives and if financial issues cannot be resolved, the study team is OK with the
participant continuing with their current medications rather than accepting potentially higher cost changes. If participants choose to
accept a higher cost medication as part of the recommended medication changes, this cost will be will be their responsibility.
Data and Safety Monitoring: The IRB requires review and approval of data and safety monitoring plans for greater than minimal risk
research, clinical research, or NIH-funded/FDA-regulated clinical investigations. 
If you are conducting greater than minimal risk research, clinical research, or your clinical investigation is NIH-funded/FDA-regulated,
describe your Data and Safety Monitoring Plan (DSMP). Click here for additional guidance on developing a Data and Safety Monitoring
Plan. 
If this is a non-sponsored investigator-initiated protocol considered greater than minimal risk research, clinical research, or your
clinical investigation is FDA-regulated, and if you are planning on using a Data and Safety Monitoring Board (DSMB) as part of your
DSMP, click here for additional guidance for information to include with your IRB application. 
This protocol will be monitored by an independent DSMB comprised of a core multidisciplinary team that has been approved by the
NIA. Contact information of the DSMB members can be found in the table below. Ad hoc members will be appointed as needed to
provide specialized expertise. The DSMB will meet on a bi-annual basis to assess the ongoing safety of protocols. Protocols are
scheduled for review prior to initiation and then on an interim basis during the trial. DSMB Information Neelum T. Aggarwal, MD (chair)
- Rush University Medical Center. Experience in geriatric medicine. Email neelum_t_aggarwal@rush.edu Demetra E. Antimisiaris,
PharmD, CGP, FASCP - University of Louisville. Experience in geriatric pharmacy and medication therapy management. Email
demetra.antimisiaris@louisville.edu Chengjie Xiong, PhD - Washington University School of Medicine. Experience in conduct of
randomized controlled trials. Email chengjie@wubois.wustl.edu
Back to Top
Subject Complaints: Describe procedures (other than information provided in consent document) for handling subject complaints or
requests for information about the research. The procedures should offer a safe, confidential, and reliable channel for current,
prospective, or past research subjects (or their designated representative) permitting them to discuss problems, concerns and
questions, or obtain information.
Participants will be encouraged to address any complaint to any member of the study team including the PI. They will be told that they
can, at any time, call the Office of Research Integrity at the University of Kentucky at (859) 257-9428 or toll free at 1-866-400-9428.
 
Section 8 Page 8 of 10
43239


Does your research involve Non-English Speaking Subjects or Subjects from a Foreign Culture?
Yes
No
Non-English Speaking Subjects or Subjects from a Foreign Culture
Describe how information about the study will be communicated to potential subjects appropriate for their culture, and if
necessary, how new information about the research may be relayed to subjects during the study.
Include contact information for someone who can act as a cultural consultant for your study.  The person should be familiar
with the culture of the subject population and/or be able to verify that translated documents are the equivalent of the
English version of documents submitted. The consultant should not have any direct involvement with the study. If you do
not know someone who would be willing to act as your cultural consultant, the Office of Research Integrity will try to find
someone to fill this role (this may delay the approval process for your protocol). Please include the name, address,
telephone number, and email of the person who will act as the cultural consultant for your study.  For more details, see
ORI’s help page on Research Involving Non-English Speaking Subjects or Subjects from a Foreign Culture.
For recruitment of Non-English speaking subjects, the consent document needs to be in the subject’s native language. 
Download the informed consent template available in the E-IRB "Informed Consent/Assent Process" section and use it as
a guide for developing the consent document. (Note: Your translated consent document can be attached to your
application in the “Informed Consent" section; be sure to save your responses in this section first.)
If research is to be conducted at an international location, identify local regulations, laws, or ethics review requirements for
human subject protection. If the project has been or will be reviewed by a local Ethics Committee, attach a copy of the
review to the UK IRB using the attachment button below. You may also consult the current edition of the International
Compilation of Human Research Standards
Section 8 Page 9 of 10
43239


Does your study involve HIV/AIDS research and/or screening for other reportable diseases (e.g., Hepatitis C, etc…)?
Yes
No
HIV/AIDS Research
If you have questions about what constitutes a reportable disease and/or condition in the state of Kentucky, see ORI’s
summary sheet: “Reporting Requirements for Diseases and Conditions in Kentucky” [PDF].
HIV/AIDS Research: There are additional IRB requirements for designing and implementing the research and for
obtaining informed consent. Describe additional safeguards to minimize risk to subjects in the space provided below.
For additional information, visit the online IRB Survival Handbook to download a copy of the Medical IRB's requirements
for Protection of Human Subjects in Research Involving HIV Testing, and visit the Office for Human Research Protections
web site for statements on AIDS research, or contact the Office of Research Integrity at 859-257-9428.
PI-Sponsored FDA-Regulated Research
Is this an investigator-initiated study that:                                                                                                                                                 
         Back to Top
1) involves testing a Nonsignificant Risk (NSR) Device, or
2) is being conducted under an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)?
Yes
No
PI-Sponsored FDA-Regulated Research
If the answer above is yes, then the PI assumes the regulatory responsibilities of both the investigator and sponsor. The Office
of Research Integrity provides a summary list of sponsor IND regulatory requirements for drug trials, IDE regulatory
requirements for SR device trials, and abbreviated regulatory requirements for NSR device trials. For detailed descriptions see
FDA Responsibilities for Device Study Sponsors or FDA Responsibilities for IND Drug Study Sponsor-Investigators.
Describe your (the PI’s) experience/knowledge/training (if any) in serving as a sponsor (e.g., previously held an IND/IDE);
and
Indicate if you have transferred any sponsor obligations to a commercial sponsor, contract research organization (CRO),
contract monitor, or other entity (provide details or attach FDA 1571).
IRB policy requires mandatory training for all investigators who are also FDA-regulated sponsors (see Sponsor-Investigator
FAQs). A sponsor-investigator must complete the applicable Office of Research Integrity web based training, (drug or
device) before final IRB approval is granted.
Has the PI completed the mandatory PI-sponsor training prior to this submission?
Yes
No
If you (the PI) have completed equivalent sponsor-investigator training, you may submit documentation of the content for the
IRB’s consideration.
Attachments
Section 8 Page 10 of 10
43239


HIPAA
Is HIPAA applicable?
Yes
No
(Visit ORI's Health Insurance Portability and Accountability Act (HIPAA) web page to determine if your research falls under the HIPAA
Privacy Regulation.)
If yes, check below all that apply and attach the applicable document(s): 
HIPAA De-identification Certification Form
HIPAA Waiver of Authorization
Attachments
Section 9 Page 1 of 1
43239


STUDY DRUG INFORMATION
The term drug may include:
FDA approved drugs,
unapproved use of approved drugs,
investigational drugs or biologics,
other compounds or products intended to affect structure or function of the body, and/or
complementary and alternative medicine products such as dietary supplements, substances generally recognized as safe (GRAS)
when used to diagnose, cure mitigate, treat or prevent disease, or clinical studies of e-cigarettes examining a potential therapeutic
purpose.
Does this protocol involve any use of a drug in a human other than the use of an approved drug in the course of medical
practice?
Yes
No
If yes, complete the questions below. Additional study drug guidance [HTML]
LIST EACH DRUG INVOLVED IN STUDY IN THE SPACE BELOW
Drug Name:
Scopolamine patch
Note: Inpatient studies are required by Hospital Policy to utilize the Investigational Drug Service (IDS). Use of IDS is
highly recommended, but optional for outpatient studies. Outpatient studies not using IDS services are subject to
periodic inspection by the IDS for compliance with drug accountability good clinical practices. 
Indicate where study drug(s) will be housed and managed:
Investigational Drug Service (IDS) UK Hospital
Other Location:
Is the study being conducted under a valid Investigational New Drug (IND) application?
Yes
No
If Yes, list IND #(s) and complete the following:
IND Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
Checkmark this if the study is being conducted under FDA's Expanded Access Program (e.g.,
Treatment IND).
FDA's Expanded Access Program Information (e.g., treatment IND)
Guidance and definitions: "Expanded Access SOP" [PDF]
Please also complete and attach the Study Drug Form (required):
[PDF]
Section 10 Page 1 of 2
43239


Attachments
Attach Type
File Name
StudyDrug
Study Drug Attachment INCREASE.pdf
StudyDrug
Transderm Scop Package Insert.pdf
Section 10 Page 2 of 2
43239


STUDY DEVICE INFORMATION
A DEVICE may be a:
component, part, accessory;
assay, reagent;
software or computer/phone application;
other instrument if intended to affect the structure or function of the body, diagnose, cure, mitigate, treat or prevent disease; or
a homemade device developed by an investigator or other non-commercial entity and not approved for marketing by FDA.
For additional information, helpful resources, and definitions, see ORI's Use of Any Device Being Tested in Research web page.
Does this protocol involve testing (collecting safety or efficacy data) of a medical device including an FDA approved device,
unapproved use of an approved device, humanitarian use device, and/or an investigational device?
Yes
No
[Note: If a marketed device(s) is only being used to elicit or measure a physiologic response or clinical outcome, AND, NO data will
be collected on or about the device itself, you may answer “no” above, save and exit this section, (Examples: a chemo drug study
uses an MRI to measure tumor growth but does NOT assess how effective the MRI is at making the measurement; an exercise study
uses a heart monitor to measure athletic performance but no safety or efficacy information will be collected about the device itself, nor
will the data collected be used for comparative purposes against any other similar device).]
If you answered yes above, please complete the following questions.
LIST EACH DEVICE BEING TESTED IN STUDY IN THE SPACE BELOW
Device Name:
Is the study being conducted under a valid Investigational Device Exemption (IDE)
or Humanitarian Device Exemption (HDE) application? See UK HUD SOP [PDF] for guidance.
Yes
No
If Yes, list IDE or HDE #(s) and complete the following:
IDE/HDE Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
 Check if this is a Treatment or Compassionate Use IDE under the Food and Drug Administration
(FDA) Early Expanded Access program.
FDA's Early Expanded Access Program Information
Guidance and definitions: "Medical Device Clinical Investigations, Compassionate Use, and
Treatment IDE SOP" [PDF]
Does the intended use of any device used in this study meet the regulatory definition of Significant Risk (SR) device?
Yes. Device(s) as used in this study presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is
intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing,
curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents a potential
Section 11 Page 1 of 2
43239


for serious risk to the health, safety, or welfare of a subject.
No. All devices, as used in this study do not present a potential for serious risk to the health, safety, or welfare of
subjects/participants.
Please also complete and attach the Study Device Form (required):
[PDF]
Attachments
Section 11 Page 2 of 2
43239


List all other non-UK owned/operated locations
where the research will be conducted:*
*A letter of support and local context is required from
non-UK sites. Click HERE for more information.
RESEARCH SITES
In order for this section to be considered complete, you must click "SAVE" after ensuring all responses are accurate.
A) Check all the applicable sites listed below at which the research will be conducted. If none apply, you do not need to check any
boxes.
UK Sites
UK Classroom(s)/Lab(s)
UK Clinics in Lexington
UK Clinics outside of Lexington
UK Healthcare Good Samaritan Hospital
UK Hospital
Schools/Education Institutions
Fayette Co. School Systems *
Other State/Regional School Systems
Institutions of Higher Education (other than UK)
*Fayette Co. School systems, as well as other non-UK
sites, have additional requirements that must be
addressed. See ORI's Off-site Research Instructions
web page for details.
Other Medical Facilities
Bluegrass Regional Mental Health Retardation Board
Cardinal Hill Hospital
Eastern State Hospital
Norton Healthcare
Nursing Homes
Shriner’s Children’s Hospital
Veterans Affairs Medical Center
Other Hospitals and Med. Centers
Correctional Facilities
Home Health Agencies
International Sites
Attachments
B) Is this a multi-site study for which you are the lead investigator or UK is the lead site?
Yes
No
If YES, you must describe the plan for the management of reporting unanticipated problems, noncompliance, and submission of
protocol modifications and interim results from the non-UK sites in the E-IRB "Research Description" section under Resources.
Section 12 Page 1 of 2
43239


If the non-UK sites or non-UK personnel are engaged in the research, there are additional federal and university requirements which
need to be completed for their participation, such as the establishment of a cooperative IRB review agreement with the non-UK site.
Questions about the participation of non-UK sites/personnel should be discussed with the ORI staff at (859) 257-9428.
Section 12 Page 2 of 2
43239


RESEARCH ATTRIBUTES
Indicate the items below that apply to your research. Depending on the items applicable to your research, you may be required to
complete additional forms or meet additional requirements. Contact the ORI (859-257-9428) if you have questions about additional
requirements.
Not applicable
Check All That Apply
Academic Degree/Required Research
Aging Research
Alcohol Abuse Research
Cancer Research
Certificate of Confidentiality
CCTS-Center for Clinical & Translational Science
Clinical Research
Clinical Trial
Clinical Trial Multicenter(excluding NIH Cooperative Groups)
Clinical Trial NIH cooperative groups (i.e., SWOG, RTOG)
Clinical Trial Placebo Controlled Trial
Clinical Trial UK Only
Collection of Biological Specimens
Collection of Biological Specimens for Banking
Community-Based Participatory Research
Data & Safety Monitoring Board
Data & Safety Monitoring Plan
Deception
Drug/Substance Abuse Research
Educational/Student Records (e.g., GPA, test scores)
Emergency Use (Single Patient)
Genetic Research
Gene Transfer
GWAS (Genome-Wide Association Study) or NIH-funded study
generating large scale genomic data
International Research
Internet Research
Planned Emergency Research Involving Waiver of Informed
Consent
Pluripotent Stem Cell Research
Recombinant DNA
Survey Research
Transplants
Use of radioactive material, ionizing radiation, or x-rays [Radiation
Safety Committee review required]
Vaccine Trials
Click applicable listing(s) for additional
requirements and/or information:
Cancer Research (MCC PRMC)
Certificate of Confidentiality 
CCTS (Center for Clinical and Translational
Science)
Clinical Research 
Clinical Trial 
Determine if research meets NIH definition of
clinical trial;
*Reminder: Ensure compliance with
clinicaltrials.gov registration requirements for
applicable clinical trials and Good Clinical
Practice (GCP) training requirements.
Collection of Biological Specimens for Banking 
Collection of Biological Specimens 
Community-Based Participatory Research 
Data & Safety Monitoring Board
Data & Safety Monitoring Plan
Deception*
*For deception research, also go to the
Informed Consent section, checkmark and
complete "Request for Waiver of Informed
Consent Process"
Emergency Use (Single Patient) [attach
Emergency Use Checklist]
Genetic Research 
Gene Transfer
HIV/AIDS Research 
Screening for Reportable Diseases [E2.0000]
International Research 
Planned Emergency Research Involving Waiver
of Informed Consent*
*For Planned Emergency Research Involving
Waiver of Informed Consent, also go to the
Informed Consent section, checkmark and
complete "Request for Waiver of Informed
Consent Process"
Use of radioactive material, ionizing radiation or
x-rays for research
Section 13 Page 1 of 1
43239


FUNDING/SUPPORT
If the research is being submitted to, supported by, or conducted in cooperation with an external or internal agency or funding program,
indicate below all the categories that apply. 
Not applicable
Check All That Apply
Grant application pending
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources and Services Administration
(SAMHSA) Substance Abuse and Mental Health
Services Administration
(DoJ) Department of Justice or Bureau of Prisons
(DoE) Department of Energy
(EPA) Environmental Protection Agency
Federal Agencies Other Than Those Listed Here
Industry (Other than Pharmaceutical Companies)
Internal Grant Program w/ proposal
Internal Grant Program w/o proposal
National Science Foundation
Other Institutions of Higher Education
Pharmaceutical Company
Private Foundation/Association
U.S. Department of Education
State
Click applicable listing(s) for additional requirements
and/or information:
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources & Services Administration
(SAMHSA) Substance Abuse & Mental Health Services
Administration
Industry (Other than Pharmaceutical Companies) [IRB
Fee Info]
National Science Foundation
(DoEd) U.S. Department of Education
(DoJ) Department of Justice or Bureau of Prisons
(DoE) Department of Energy
(EPA) Environmental Protection Agency
Other:
Specify the funding source and/or cooperating organization(s) (e.g., National Cancer Institute, Ford Foundation, Eli Lilly
& Company, South Western Oncology Group, Bureau of Prisons, etc.):
 
National Institute on Aging
Add Related Grants
If applicable, please search for and select the OSPA Account number or Electronic Internal Approval Form (eIAF) #
(notif #) associated with this IRB application:
Add Related Grants
Grant/Contract Attachments
The research involves use of Department of Defense (DoD) funding, military personnel, DoD facilities, or other DoD resources.
(See DoD SOP [PDF] for details).
Yes
No
Using the “attachments” button (below), attach applicable materials addressing the specific processes described in
the DoD SOP.
DOD SOP Attachments
Section 14 Page 1 of 2
43239


Additional Certification: (If your project is federally funded, your funding agency may request an Assurance/ Certification/Declaration
of Exemption form.) Check the following if needed:
Protection of Human Subjects Assurance/Certification/Declaration of Exemption (Formerly Optional Form – 310)
Section 14 Page 2 of 2
43239


OTHER REVIEW COMMITTEES
If you check any of the below committees, additional materials may be required with your application submission.
Does your research fall under the purview of any of the other review committees listed below? [If yes, check all that apply and attach
applicable materials using the attachment button at the bottom of your screen.]
Yes
No
Institutional Biosafety Committee
Radiation Safety Committee
Radioactive Drug Research Committee
Markey Cancer Center (MCC) Protocol Review
and Monitoring Committee (PRMC)
Graduate Medical Education Committee (GME)
Office of Medical Education (OME)
Additional Information
Institutional Biosafety Committee (IBC)--Attach required IBC
materials
Radiation Safety Committee (RSC)-- For applicability, see
instructions and/or upload form [WORD] [RTF]
Radioactive Drug Research Committee (RDRC)--information
Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC)**--Attach MCC PRMC materials, if any, per
instructions
See requirement of Office of Medical Education (OME)
See requirement of Graduate Medical Education Committee
(GME)
Attachments 
** If you are proposing a study involving cancer research, be sure to have "Cancer Research" marked in the E-
IRB "Research Attributes" section. If your study involves cancer research, ORI will provide a copy of your research
protocol to the Markey Cancer Center (MCC) Protocol Review and Monitoring Committee (PRMC). The MCC PRMC is
responsible for determining whether the study meets the National Cancer Institute (NCI) definition of a clinical trial and for
issuing documentation to you (the investigator) which confirms either that PRMC approval has been obtained or that PRC
review is not required. Your IRB application will be processed and reviewed independently from the PRMC review.
Section 15 Page 1 of 1
43239


ADDITIONAL INFORMATION/MATERIALS
Do you want specific information inserted into your approval letter?
Yes
No
Approval Letter Details (e.g., serial #):
Submission Description: If you wish to have specific details included in your approval letter (e.g., serial #, internal tracking
identifier, etc…), provide that information here as you wish it to be seen on the approval letter. These details will be automatically
merged into a field at the top of the approval letter when it is generated. If these details need to be changed as a result of
revisions or modifications to the application, you are responsible for updating the content of the field below accordingly.
Protocol/Product Attachments - For each item checked, please attach the corresponding material.
Detailed protocol
Dept. of Health & Human Services (DHHS) approved protocol (such as NIH sponsored Cooperative Group Clinical Trial)
Drug Documentation (e.g., Investigator Brochure; approved labeling; publication; FDA correspondence, etc.)
Device Documentation (e.g., Manufacturer information; patient information packet; approved labeling; FDA correspondence,
etc.)
Other Documents
Protocol/Product Attachments
NOTE: Instructions for Dept. of Health & Human Services (DHHS)-approved protocol [HTML]
If you have password protected documents, that feature should be disabled prior to uploading to ensure access
for IRB review.
Additional Materials:
If you have other materials you would like to include in your application for the IRB’s consideration, please attach using the Attachments
button below.
[To view what materials are currently attached to your application, go to “Application Links” in the menu bar on the left and click “All
Attachments”.]
Attachments
Attach Type
File Name
AdditionInfoConsiderations CR 16-0375-F2L SN017.pdf
AdditionInfoConsiderations INCREASE Form T.PDF
Section 16 Page 1 of 1
43239


SIGNATURES (ASSURANCES)
On all IRB applications there is a requirement for additional assurances by a Department Chairperson (or equivalent) [hereafter referred
to as "Department Authorization"], and when applicable, a Faculty Advisor (or equivalent), which signifies the acceptance of certain
responsibilities and that the science is meritorious and deserving of conduct in humans.
For a list of responsibilities reflected by signing the Assurance Statement, download the guidance document "What does the
Department Chairperson’s Assurance Statement on the IRB application mean?" 
Required Signatures:
First
Name
Last
Name
Role
Department
Date
Signed
 
Daniela
Moga
Principal
Investigator
Pharmacy
Practice &
Science
01/11/2018
11:45 AM
View/Sign
David
Burgess
Department
Authorization
Pharmacy
Practice &
Science
01/11/2018
01:10 PM
View/Sign
Principal Investigator’s Assurance Statement
I understand the University of Kentucky's policies concerning research involving human subjects and I agree:
1. To comply with all IRB policies, decisions, conditions, and requirements;
2. To accept responsibility for the scientific and ethical conduct of this research study;
3. To obtain prior approval from the Institutional Review Board before amending or altering the research protocol or
implementing changes in the approved consent/assent form;
4. To report to the IRB in accord with IRB/IBC policy, any adverse event(s) and/or unanticipated problem(s) involving risks to
subjects;
5. To complete, on request by the IRB for Full and Expedited studies, the Continuation/Final Review Forms;
6. To notify the Office of Sponsored Projects Administration (OSPA) and/or the IRB (when applicable) of the development of
any financial interest not already disclosed;
7. Each individual listed as study personnel in this application has received the mandatory human research protections
education (e.g., CITI);
8. Each individual listed as study personnel in this application possesses the necessary experience for conducting research
activities in the role described for this research study.
9. To recognize and accept additional regulatory responsibilities if serving as both a sponsor and investigator for FDA
regulated research.
Furthermore, by checking this box, I also attest that I have appropriate facilities and resources for conducting the study. If
applying for an exemption, I also certify that the only involvement of human subjects in this research study will be in the
categories specified in the Protocol Type: Exemption Categories section.
*You will be able to "sign" your assurance after you have sent your application for signatures (use Submission section). Please notify the
personnel required for signing your IRB application after sending for signatures. Once all signatures have been recorded, you will need
to return to this section to submit your application to ORI. 
Department Authorization
 This is to certify that I have reviewed this research protocol and that I attest to the scientific validity and importance of
this study; to the qualifications of the investigator(s) to conduct the project and their time available for the project; that
facilities, equipment, and personnel are adequate to conduct the research; and that continued guidance will be provided
as appropriate. When the principal investigator assumes a sponsor function, the investigator is knowledgeable of the
additional regulatory requirements of the sponsor and can comply with them.
*If the Principal Investigator is also the Chairperson of the department, the Vice Chairperson or equivalent should complete
the "Department Authorization".
Section 17 Page 1 of 2
43239


Section 17 Page 2 of 2
43239


SUBMISSION INFORMATION
Each Section/Subsection in the menu on the left must have a checkmark beside it indicating the Section/Subsection has been
completed; otherwise your submission for IRB review and approval will not be able to be sent to the Office of Research Integrity/IRB.
If your materials require review at a convened IRB meeting which you will be asked to attend, it will be scheduled on the next available
agenda and a message will be forthcoming to notify you of the date.
Your protocol has been submitted.
The PI must login to submit this protocol.
Section 18 Page 1 of 1
43239


 
Document Type
File Loaded
Document
Description
File
Size
Modified
By
Mod Date
ApprovalLetter
ApprovalLetter.pdf
 
0.059
pkma223 3/6/2018 3:56:01
PM
Stamped Consent Form
INCREASE Form C V5.pdf
 
0.222
pkma223 3/6/2018 3:56:01
PM
AdditionInfoConsiderations
INCREASE Form T.PDF
Form T
0.224
pkma223 1/31/2018 3:56:02
PM
AdditionInfoConsiderations
CR 16-0375-F2L SN017.pdf
Continuation
Review 2018
2.245
bfbe223
1/11/2018
10:18:21 AM
DataCollection
11 - EOS Questionnaire.docx
 
0.015
bfbe223
1/9/2018 5:17:46
PM
DataCollection
17 - Baseline Questionnaire.docx
 
0.018
bfbe223
1/9/2018 5:17:32
PM
DataCollection
16 - SF-36.pdf
SF-36
0.064
bfbe223
1/9/2018 5:16:55
PM
DataCollection
Lifestyles Survey_Follow-Up.docx
EOS Lifestyles
Survey
0.091
bfbe223
1/9/2018 5:16:24
PM
DataCollection
Lifestyles Survey_V6.0_Initial
Packet.docx
Initial Lifestyles
Survey
0.062
bfbe223
1/9/2018 5:15:59
PM
DataCollection
INCREASE Study Procedures.pdf
 
0.261
bfbe223
1/9/2018 5:15:10
PM
Advertising
INCREASE Recruitment Letter Version 5
CLEAN.pdf
 
0.045
bfbe223
12/19/2017
12:45:36 PM
Advertising
INCREASE_flyer_Version_3.pdf
 
1.191
bfbe223
12/19/2017
12:45:22 PM
StudyDrug
Transderm Scop Package Insert.pdf
 
0.543
bfbe223
12/19/2017
9:34:20 AM
StudyDrug
Study Drug Attachment INCREASE.pdf
 
0.304
bfbe223
12/19/2017
9:32:16 AM
Informed ConsentHIPAA
Combined Form
INCREASE Form C V5.pdf
 
0.100
bfbe223
12/18/2017
4:04:52 PM
Section 19 Page 1 of 1
43239


Protocol Changes
Protocol Number: 43239
No Changes
There are no recorded changes tracked for this protocol.
Study Personnel Changes:
No Changes
There are no recorded changes to study personnel.
Section 20 Page 1 of 1
43239


Section 21 Page 1 of 1
43239