- [Announcer] The Dementia

Researcher podcast,

talking careers, research,

conference highlights,

and so much more.

- Hello and welcome to the

Dementia Researcher podcast.

In this episode, we are

exploring methodology

in dementia clinical trials,

particularly what it is like

for early career researchers

entering this field,

and how trials extend much

further than medicines.

(upbeat music)

I'm Dr. Annalise Rahman-Filipiak

from the research programme

on Cognition and Neuromodulation

Based Interventions

at the University of Michigan.

And I am delighted to be

hosting this week's show.

Clinical trials are often viewed

as a domain of pharmacology,

yet in dementia research,

trials include behavioural interventions,

sensory environments, sleep

and activity interventions,

and many other approaches.

These studies require careful design,

strong methods and collaboration.

And many early career researchers tell us

that they feel unprepared

when first entering this work.

So today that's what we wanna get into.

To explore this I am

joined by three guests

who each work on clinical

trials in different ways

and who are part of

ISTAART's clinical trials

and advancement of methods PIA.

First, Dr. Elizabeth Rhodus,

assistant professor at the

University of Kentucky,

whose work focuses on multisensory

and home environment interventions

to support people living with dementia.

Hello, Elizabeth.

Dr. Inga Antonsdottir,

researcher at Johns Hopkins University,

whose work examines

sleep circadian rhythms

and neuropsychiatric symptoms

with a growing programme of trial methods.

Hi, Inga.

And finally, Dr. Elisa Franca Resende,

neurologist and researcher

at the Federal University

of Minas Gerais in Brazil,

whose research explores cognitive reserve,

literacy and dementia prevention,

including applied trials

in diverse populations.

Hello, Elisa.

Hello, everyone, thank

you for having me here.

Okay, so thank you again for joining us.

To start us off, could I ask each of you

to introduce yourself in your own words?

Maybe we can start with you, Elizabeth.

- Sure, yeah, thank you so much.

I clinically have a background

as an occupational therapist

and my training started in

paediatrics and neurodevelopment.

So I come to this stage in dementia care

or in Alzheimer's disease

and related dementias

really with this idea of neurodevelopment

to neurodegeneration and how do we support

both sides of the lifespan

through an environmental

and sensory based approach.

So if we have a baby

who is having a hard

time calming itself down,

we naturally swaddle that baby, right?

We give it full body proprioceptive input

to regulate its nervous system.

We rock the baby, we sing to the baby,

we give lavender-infused

lotions to the baby.

So we care for this

brand new nervous system

in a way that's environmental

and sensory based.

How can we rigorously design and assess

and test a similar type of

intervention for older adults?

We're not gonna swaddle our elders,

but how can we create an environment

that's gonna provide

similar input in that way?

So that's really my research

and my experience thus far.

- Honestly, Elizabeth, that

sounds fantastic for all of us.

So very excited to hear more.

Inga, what about you?

- Thank you so much for having us today.

So I'm Inga Antonsdottir.

I'm actually a postdoctoral

research fellow

at Johns Hopkins.

And my research interests

lie at the intersection

of Alzheimer's disease

and related dementias

and then sleep and circadian

rest activity rhythms

in people living with dementia,

but also in their care partners.

So tailoring interventions to

make it as easy as possible

for us to treat any type of

sleep disorder or disruption.

And then I'm also a nurse

practitioner in our memory clinic,

so I'm able to see, treat,

and assess people with memory disorders

as well as other

neurodegenerative diseases.

So beautiful way to kind of

combine that clinical practise

and the research and see

where the gaps might be.

- Fantastic, so glad you're here.

Now Elisa.

- Yes, I'm Elisa Resend.

I'm a neurologist from Brazil.

And when I was a medical student,

I was impressed by the fact

that many of our older

adults with dementia,

they were illiterate.

And then my curiosity began

about how literacy can be

a risk factor for dementia.

So I built my career research

around understanding this in their brains,

and then developing a child to understand

if literacy giving to older adults

could improve brain health.

Fantastic.

(upbeat music)

- So I'd love to start

our conversation today

by talking about early career research

and entering this field.

So many early career researchers

say they feel unprepared

for trial design and conduct.

So let's begin with your own journeys.

Elizabeth, Inga, and Elisa,

could you each describe

how you found yourselves

working in clinical trials?

Was that a deliberate decision,

or just something that

developed gradually?

- Yeah, so I could definitely start off.

I was incredibly lucky

in my pre-doctoral work

to slowly but surely get introduced

to different clinical trialists.

And we were doing community-based trials.

So Dr. Quincy Samus who had recently

kind of closed up her

project mind at home.

And we were just starting memory corps,

which was an association with

the Alzheimer's Association,

and then also (indistinct)

who was adapting one

of her clinical trials,

her clinical programmes.

But being exposed to those

programmes so early on

and how you can go into the home,

how you're able to kind of work

with people living with dementia,

memory disorders and their care partners

and adapt things in a way

that's going to do what's best for them,

but also still giving them

kind of this beautiful intervention

that's going to help our knowledge

of what to do at home

versus what to do in clinic.

I was just very fortunate

that that's kind of how my

pre-doctoral work started,

and I've been able to kind

of have a foot in the door

at every step of the way and now I get to,

hopefully, build my own practise

and kind of understanding of

how to develop these trials.

- That's so interesting.

So you came in with very

pragmatic community trials

as opposed to, you

know, some of the trials

that we hear about that are,

you know, purely lab-based.

I'm wondering if you could

share if there were surprises

or challenges in the pragmatic trial space

that you didn't expect?

- Yes, so many different

surprises and just as you're,

it's amazing to learn

kind of the book side

of clinical trials and then

what happens in the real world

and realising that life can

be messy and that's okay.

But the methodology we

have to kind of make sure

that we're putting rigour into our trials,

even though life gets messy,

so that when we kind of look

back and we get that data,

it's as clean as possible

so that we can generalise

what we found to other people

and make sure that it's reproducible.

That was definitely doing home visits.

It's such a privilege

to be able to be invited

into somebody's home and to

try and help figure things out

and into their lives generally.

And I'm sure the other

researchers on this call

have had some of those experiences

where you just learn that one

thing will work for someone

and it might not work for another,

and we have to adjust and

everything is kind of personal.

And so, it deserves to have

kind of a personal touch,

but we also have to maintain

the rigour of our methods

and make sure that we're able to reproduce

what we're kind of creating in this world.

- Thank you so much, I really appreciate

you talking about that 'cause I think

that is a misconception

that we have about trials,

is that sometimes we take away the,

sort of human or

interactional piece of it,

but your work is such a great testament

to the fact that we can do both.

Elizabeth, how did you

come into this space?

- Yeah, I would love to follow

up on what Inga was saying.

As an occupational therapist,

I'm based in Kentucky and was

working in eastern Kentucky.

We don't have a whole lot of resources.

It's Appalachia, right?

So in going into these homes

and using the programmes

that Inga was actually involved

in developing these manualized programmes

that had an occupational

therapy component,

I was recognising that we

were adapting the home,

we were improving safety, we

were trying all that we could,

but there was still something missing.

There was something missing related

to the caregiver training,

that this nervous system is

now degenerating and dying

and how do we accept that?

There was something missing

about regulating behaviours

through this sensory based approach.

None of the research 15 years

ago was talking about that.

And so I went in, I decided at

that point, let's get a PhD,

let's see what I can figure out.

But I had never wanted

to be a doctor, or a PhD,

or any of this space.

I was a clinician and I still,

even though I'm faculty, I

still see myself as someone

who really cares about

this clinical aspect.

And so, I want to improve care.

I came into this space

saying, I'm gonna get a PhD,

I'm gonna do a clinical trial

with a sensory-based intervention

that we've seen productive

and useful in autism spectrum disorder.

And I'm gonna do it in

people with dementia.

Thankfully, I had some really

good mentors and they said,

"No, you're not.

You have to prove the fact

that you can use a paediatric intervention

in a dementia population

with basic science showing

this level of interaction first."

So during my PhD, I actually

worked with the University

of Kentucky Alzheimer's

Disease Research Centre

that carries a longitudinal

cohort of up to 700 people

and we surveyed people who

had a diagnosis with dementia,

so over 350 people.

And we found that this

group of population,

or these group of people also

had behaviours characteristic

of autism spectrum disorder

that aren't already collected

or analysed in our basic

neuropsychiatric symptom inventory.

And we actually follow people to autopsy,

and their brains and the

pathology distribution

actually look different.

So we're working with a group of people

that have behavioural symptoms.

We don't have any treatment,

let's think outside of the box.

At that point, Dr. Greg Jicha

at the University of Kentucky

is our a world renowned clinical trialist

and really designs the pharmaceuticals.

He designs the mechanisms

to create the medications

to cure and treat Alzheimer's disease.

He likes what I was

doing, but it wasn't sure.

He would call it Rhodus magic sometimes.

But I would come in and I would say,

"Well, here's my protocol,"

and he would ask me questions,

and I'd say, "Well, the

therapist is just gonna use

their clinical judgement ."

And he said, "The hell, they

are, that's not rigorous.

You have to put down exactly

what you're gonna do in your protocol

and you have to measure that."

So it took me about a year and a half

of asking how do we individualise

or how do we operationalize an

individualised intervention?

And through that it's

really about assessments

and decision matrices.

If this person scores

this on this assessment,

then we're gonna treat them this way.

If they score this, then

they're presenting this way,

then we're gonna give them this group

of intervention supplies or

tools or whatever it might be.

So that really opened the door

for me to understand

how we can use this idea

that people are using in

precision-based medicine

to tailor medications based on genetics

and really dial in at

the pharmaceutical level.

How do we develop and

implement precision-based care?

How do we create an environment

and care systems that are really tailored

to that individual to maximise success,

but how do we do it in a rigorous way

that we can replicate

over and over and over?

So that's kind of my space

and how I've gotten here.

I've had three clinical trials now

that are all in this idea

of behavioural intervention

and caring for people in their homes.

I've been all funded by the

National Institute on Health,

so I've been really fortunate

to have great training,

to have great funding and

support and see where it goes.

- That's an incredible story.

And what I really like about it is that

it's a somewhat non-traditional

pathway towards trials.

And I love that you're applying so much

from your clinical background.

I think that really

helps develop new ideas,

and bring a new perspective

to the work that's done.

You mentioned something

that I do wanna return to,

which is this idea of mentorship.

I think mentorship and sponsorship

is really what can help

an early career person

have the confidence to move forward

and sometimes the resources

and infrastructure as well.

Would you be willing to

talk a little bit about

just how mentorship played a role

in you being so successful at this point?

- Absolutely, I've told

Dr. Jicha so many times

that he opened doors for me

that I didn't even know existed.

I was in a health profession,

I was doing evidence-based

care out in the field,

but I didn't know, I was

not trained in a school

that had a path for research.

I went to a smaller

school, it was not an R1,

so I've never really been in a lab.

I didn't know what this looked like.

So without that mentorship,

without that little piece

of him believing in me

and then kicking me along,

with me kicking and screaming, literally,

because I didn't see

the world how he saw it.

And he's a renowned neurologist,

he's also the clinical side, right?

He understands how clinicians

think and provides resources,

but he also has that PhD

and leads clinical trials

and really strong science.

And through his mentorship and training,

I really was able to tailor

and learn my space and place in this.

But I also had multiple

different types of mentors.

You know, I would go to him

for the really science-based things

and then I would have the other mentors

that I'd be texting at night,

like, crying, like, I can't do this.

I'm lost, I don't know what to do.

Or the next person of,

how do I really make sure

that my career is blossoming

and that I'm well-rounded

and I'm getting all

the skills that I need,

but not burning at both ends

and making sure that, you know, I'm young,

I have a 2-year-old at home, right?

So how do I blend this space

of advancing my academic career,

leading the field and clinical trials

within occupational therapy

and being true to myself,

as a mom and a wife and me, right?

So I think that that mentorship landscape

really was what helped create me

and allowed me to get to this point.

- Kind of wanna piggyback on that.

I second everything that

Elizabeth is saying,

and mentorship is so important

and that team-based approach.

I love how you described that,

you know, it's not always one person

that you go to everything for.

It's very much a team of

people who lift you up,

and help you understand different

aspects of the research,

different aspects of work-life balance.

I, too, have been just

absolutely incredibly lucky

with the mentorship teams that have

kind of become my village,

for lack of a better word,

and just to be able to go to people

and kind of ask questions.

And then finding mentorship

outside of academia.

There's different groups

and I know we're gonna talk

about this a little bit later

with the clinical trials PI.

You can find different

PIs for different areas

of research that you want.

And finding those people that

you're able to kind of go to

that are at different universities

or in different spaces in life.

There's another one IMPACT-AD

where Elizabeth and I

actually got to meet,

and you're able to surround yourself

with other researchers

either at your stage

or a little bit above

or a little bit below.

And it's amazing just being

able to chat with people

and have those ideas kind of

spur off of one one another,

and really just learn from each other

and make the science

and the research space

just keep evolving and

keep getting better.

- I think that's excellent advice.

- I have to throw out

there that Inga's father,

is another world renowned

clinical trialist

at the University of Rochester.

- I'm in his office.

- He's one of my mentors for my,

I have a career development

award through the NIH,

and he is one of my mentors.

So he's one of those people

that I call every other month of like,

what am I doing, are

you sure I can do this?

Fantastic, so I just wanted to

plug in here for him as well.

- It's a beautiful small world.

We all like each other.

We all, like, want learn

and grow from each other.

And I think that's one of

the best things, Elisa,

and I feel like I'm talking

over everyone, though.

- Yeah, I mean, great notes

about a mentoring network.

I think that's excellent advice.

Elisa, I'm really interested to hear

how you came into this field.

- Yeah, so my path is

a little bit different

because in Brazil it's really

hard to do clinical trials.

That's true because of the rigour,

because the ethical approval is very long.

Sometimes can take two years

to have an ethical approval here.

So I started, like, trying

to understand why illiteracy

was a risk factor.

So I was looking into the MRI,

so to correlate MRI with memory

and to see if there is a correlation

between illiteracy and poor memory.

So I found a lot of evidence that,

yes, they had poor memory, they

had poor brain connections,

but everybody was asking

me, what do you know?

It's interesting that they have

poor memory, but what else?

Do you know if you do something,

can you do something about it?

And I think all of you

talked a little bit about,

we want to improve patients

and people's lives,

so there is no point of

discovering something

and then you cannot, like,

put that into practise

to improve their lives.

So that's how I entered this world,

a little bit afraid to

be honest because I was,

oh, my God, I'm going

to do a clinical trial.

When I was like writing

clinical trial, I was like,

I'm not sure if I'm

doing a clinical trial.

But anyway, so I had incredible

support from mentors.

My mentor here in Brazil.

He led a lot of clinical trials here,

medicine, behavioural intervention.

So he had a lot of experience, he helped.

And I had like the Global

Brain Health Institute training

that some of you may know.

It was a wonderful experience

and I learned a lot about

leadership, team management,

some things that are really important

in running a clinical

trial, respect, community,

like, involvement with the community.

And also I had the IMPACT-AD training,

and I think it was,

I did the clinical trial before

and when I did the IMPACT-AD

training, I was like,

oh, my God, I should, I

made a lot of mistakes.

And they say, no, it's okay.

I say, okay, you know, so

the papers, they're like,

you know, there's this, this,

this and that, I'm so sorry.

But anyways, I learned a lot,

and I entered this word

to actually to show,

so to prove and to bring

this to public policy

because some schools here in Brazil,

they were about to close

for adult literacy training

because the government said,

ah, you know, they don't do anything.

They just go there, don't learn.

And I was trying to show that they learn,

their brains get better,

so you should invest

in this approach here.

So that's how and I agree with our field,

like, mentorship is incredible important.

And I had like, and I think I

have to say about women here

because I had a male mentor, he's amazing,

but he doesn't understand

the woman stuff, you know?

You said being a mom,

and one of my mentors,

she had three children, and I was like,

okay, if she can do it, I can do it.

So I also had two children,

three I think is too much,

but I had two.

And like, she helped me

with managing career,

as Elizabeth said, career

and being a clinician

and also the clinical trials

did the research part.

And funding is a very important,

so my first, first trial,

pilot trial was from the

Alzheimer's Association,

so the grant.

So I think you should go

there and find grants.

To start you need to do a pilot, right?

A small pilot, few people, feasibility,

and then you go over into larger one.

- Thank you so much.

I mean, I really wanna point out,

A, that all of us to

some extent experienced

or talked about some imposter

syndrome entering this space.

And I think that's for a lot of reasons.

But we also talked about some

of the tools we have relied on

or benefited from in

order to overcome that.

I wanna shift the conversation

a little bit to a new topic,

which somewhat relates

to imposter syndrome.

I think coming into the trial space,

there was so much emphasis on medicines

or pharmacology as the true trials,

yet each of you works on interventions

that are so far beyond that

and incredibly important

and translational and

affecting policy, you know?

So I'd love to hear a

little more about that.

Elizabeth, could you tell us

more about your multisensory

and home environment work

and how applying trial

methodology has shaped that?

- Absolutely, thank you for that question.

If we think about,

at least within the

United States landscape,

insurance and Medicare and Medicaid pay

for interventions that are evidence-based.

Evidence-based really boils

down to the gold standard

of clinical trial methodology.

If we as clinicians have

anecdotal interventions

and programmes and things that we see

are working in the field,

but that don't necessarily

have that gold standard

to back it up from an

evidence-based standpoint,

then we can't change policy.

We can't show up and say,

these are what we need to do

because here's the evidence.

You can't deny facts, right?

So thinking about how do

we take this concept of,

we each have these ideas

and we wanna change and improve care,

but we have to do it within a

space of evidence-based care

that boils down to

clinical trial methodology.

But a lot of our professions may not be,

you know, in developing and

designing clinical trials

at the level of medicine.

So how do we boil that down?

There's actually several different models

that have really been integrated

into how I've developed my interventions

and how I use the environment

that NIH has a stage model

of behavioural intervention development.

So it talks about the stage

zero of like the basic,

understand your mechanisms

that are influencing what

you're gonna measure.

Stage one is then looking at

the pilot and the feasibility.

Stage two is similar to,

like, a phase two clinical

trial of a medicine,

which you're looking at the efficacy.

In ideal situations, can you

actually show a difference

because of your intervention?

The third is looking at the effectiveness.

Then we're moving into

implementation and sustainability,

and really looking at this full circle of,

how do we create a manualized intervention

regardless of if it's how people sleep

and prepare to sleep or how they exercise

or how they design their home environment.

It's about creating a manual,

a protocol that you can measure.

And if you need to tailor

it here, there, do that,

but put that in your

measures and your rigour

so that you can replicate

it over and over.

So going back to the question of,

specifically, how does multisensory

and home environment come into play?

I mentioned earlier this

idea of assessments.

So let's understand the

personal preferences

and the personal processing ability

or capacity of that individual's brain.

For example, we had an individual

who was refusing to take showers

and we did the adult

sensory profile with him,

and we found out that he

had tactile defensiveness.

He didn't wanna be touched,

especially in his feet.

He didn't wanna be touched in his feet.

So we talked to the

occupational therapist,

talked to the wife and said,

"Have you ever heard or

considered using water shoes,

those little non-skid

shoes that people wear

to the beach or whatever?"

And she left and said,

"We used to go to the lake every summer

and he would never take his shoes off.

He always had water shoes on

and we still had four pair in the closet."

So the OT said, "Well, why

don't you put him in the next

to the shower to create an environment

that's prepared for him with

the tools that he needs?"

The man independently

put on his water shoes,

got in the shower, gave

himself a shower and got out

without any behavioural

problems or resistance.

He could still independently

give himself a shower.

He couldn't communicate the need

that he didn't want his

feet wet or touched,

and he didn't have the resources anymore,

the capacity to go ahead

and independently create,

seek out the shoes or, you

know, set up that environment

in a way that's prepared for

what his specific needs are.

So creating an environment,

or home using these sensory elements,

or really thinking about

these individual needs,

figuring out how do we make it fit?

And then training the caregivers

to really be the tool to

implement these spaces.

Because, like Inga mentioned

earlier, everybody is different

and every care situation is different.

We don't have manuals on

how to raise children,

we don't have manuals on

how to help support people

through the terminal process of dementia,

but we can find these little ingredients

that will make things a little bit easier

and a little bit smoother as we go.

- That's amazing and thank

you for sharing that story.

And I think it, another

aspect that I really love

to bring up is involving

participants from the beginning

because of stories just like this

where we don't know what's happening

in every single situation

or every single family.

And there's so many things

that people have already figured out

that can then help another

family or another person.

And so, involving people

who are living with dementia

or their care partners or their clinicians

who maybe have insight

into what might work,

what might not work from the beginning

just to see is this something

that people would actually respond to

or that they would like,

or are we delivering it

in a way that is helpful

or is it actually more of a burden?

And I think that's a

really important aspect

of kind of methodology and trial design

and having a community advisory board.

Because in the end, we're trying

to do good on our patients,

we're trying to do good for people,

and we're trying to make these

interventions really work

and work be accessible.

And I think involving

people from the get go

and having stories like

the one you just told

is so important because

we wouldn't know that

if we didn't have that story

attached to everything.

And I just, that was absolutely beautiful,

so thank you so much for

sharing that, I think, so.

- Yeah, thank you for your comments.

I will say there's one

other element to that too,

of when we're putting

people in clinical research,

it's kind of hard.

It's hard to do things, it's

hard to track your behaviours,

it's hard to learn something new.

And so making sure that we're compensating

and supporting caregivers,

but in the very beginning of

this journey that I've been on,

I had, you know, social

support teams tell me

they weren't gonna refer

people to my clinical trial

because I was asking them to do too much,

that it was gonna be too burdensome

on people that were already burdened.

Thankfully, we talked through it,

and we did end up getting

full enrollment for the trial,

but we tracked caregiver burden.

And what we found is that

burden didn't get worse.

It actually improved, people felt better.

And we know that from

other evidence as well,

that when we give caregivers the tools

and the techniques to provide the care

and teach them how to kind

of understand this process,

their burden doesn't go away completely,

it's hard to care for

people, but it gets better.

It's not as stressful,

it's not as strenuous,

and they can be able to prepare and adapt,

and live this life the best

they can with the tools

that they need with less

stress and higher satisfaction.

- I really appreciate the attention

to patient-oriented and

community-oriented work

and how you're integrating

that into your trials.

I think this is a great

point to bring Elisa in

given all of the work

that you've been doing,

I'm sure community partnership

is such a massive part.

Would you tell us more about that

and maybe other

methodological considerations

that come up in your trials?

- Yeah, sure, so I am a neurologist

and I decided to work

with literacy training.

So first challenge was

how to deliver literacy.

So I had to engage with a

educator, a teacher, a pedagogue,

and she's specialised in adult education.

And I showed her, I

didn't do this first part

of community engagement the first time.

So I showed her my

protocol and it was like,

oh, in, like, very small letters,

and not in capital letters.

And she said, the participants

will never do that.

It's impossible, they are literate.

And I said, oh, no, I never realised.

So I had to spend a time with

her developing the protocol.

And then I spent a time with the teachers,

the teachers in the

room, the teaching room,

to ask them what would

work the assessments,

like, the outcomes that would be important

for them and for the students.

And then I also, like Elizabeth,

spent, like, almost one

year developing the protocol

because it was from the beginning

my initial protocol was totally wrong.

And at the same time,

I needed to have hazards and tools

that were already published

in the literature.

And that was already another challenge

because it is in Portuguese,

it has to be in Portuguese

because it's in Brazil,

they speak Portuguese,

they won't say anything in English.

And there was not a lot

of literature out there,

and instruments that were

validated some things.

So we had to develop a lot of instruments.

And the teacher I engaged with the leader,

she developed a protocol to teach adults

and she published because of the child.

So we had this,

like, this care of publishing things

that we used so people could understand

and our trial could be reliable

and with the rigorous that it's needed.

But I'm also have to say

that I am very touched

about Elizabeth story.

As a neurologist who takes

care of people with dementia,

I see this a lot.

And sometimes really hard

during the consultation

to understand this, you

know, at this small details.

But it has a lot of difference.

And the easy part is

to give a pill, right?

So to just like run a

clinical trial for pills for,

you know, behavioural problems.

But you see, you have

like this very interesting

and multisensory

intervention that it's safe

and it makes a lot of difference.

- You know, as you were

talking, I had this thought,

if it's okay, I'll just

throw it out there.

We talk about health

disparities a lot, right?

And the differences that

people have with access to care

and all the things that lead

in to health disparities.

But as you're talking, Elisa,

there's this element of,

I don't know if we would

call it disparities,

but disparities in trial

readiness for clinicians

and researchers across the world.

We have different levels of accessibility,

like validated tools and

assessments in English

that you have to overcome those hurdles.

Or I can get an IRB passed

in two to three weeks

compared to two years, right?

So there's these elements

that really facilitate

and allow kind of changes the

landscape of how easy it is.

Everything is hard, behavioural

trials are hard, period,

but I feel like there's

so many different elements

that make it even more hard based

on the environment that you're in.

So kudos to you for being able

to overcome so many barriers

and that push and that

will to just keep going.

But I think it ties into, you know,

early career researchers across the world

and how do you get started,

but I guess making sure

that we're identifying the resources

and maybe we need to start writing up

and talking about the barriers

to becoming a clinical trialist

just at that really basic level.

- Yeah, and I've absolutely gone through

so many different challenges

and just the resilience it takes

to keep going and to

have this idea and say,

this is so worthwhile and we need this.

And to keep that moving.

I think that's absolutely beautiful.

- Yeah, that's true for early careers,

especially in non-US based

or non-Europe, let's say.

I know Europe is also challenging,

so easy some places, right?

But so non-US or non-Europe based,

we face a lot of challenges.

So language and the preparedness

of the participants too.

There is some misconception

about participating in a try-on,

saying, ah, you are going to be a,

I forgot the name in

English, a pig man, no.

- A guinea pig.

- A guinea pig, that's it.

I don't want to be a guinea pig.

And it is really hard to get their trust

because they were, like,

they were excluded from life

from the beginning of their life.

So for 50 years they don't

know how to read and write.

So everything, they had to ask people,

they are very ashamed of that

to say that they don't read.

So in the school they assume that,

but if you go to the

community and you show,

for example, a prescription,

a doctor's prescription,

and sometimes the participant say,

or the patient looks at the prescription,

and they say, do you know how to read?

And the person says no.

And it's really, so this

person to engage this person,

the clinical trial is

really hard to go to the MRI

and to do this, you

know, paper, pencil test.

So this is disparity that we have to face.

But I said I didn't want to give up

because I wanted to give this step,

so other people can come

to and give this a step,

but it's really a challenge.

But I think everyone in

the early career world,

especially in the non-US and non-Europe,

don't give up, go for it,

you're going to do it.

- So even just talking

about an IRB being passed

in two or three weeks versus two years,

and sometimes it's up, you know,

depending on the trial

it's a little bit longer.

Early career researchers trying

to break into the clinical trial space.

Clinical trials take a long time.

And I think that's a huge barrier

when you're just starting to get into it.

When your early career you have

to look at the promotions committee

and how am I going to get that next job?

Because a clinical trial

won't generate any data

for papers for several years.

And I think that's a

big thing that kind of,

if you have a great mentor,

they can talk about that early on.

I'm extremely fortunate.

I have, (indistinct) has,

you know, kind of taught me

from my very early stages of career to,

hey, you have to have

different streams of research.

You have to have, you know,

papers that you're putting out

so that you can show that

you're growing as a researcher.

So, so you can show expertise

so that you can show

kind of that there is this progression.

And I think, Elisa, you talked about that,

that you needed certain

and certain aspects

of your trial kind of taken care of

before you could go to the clinical trial.

And then you can build

your clinical trial,

but it almost has to be on the side.

So a clinical researcher,

especially early career,

has to wear two hats.

You have to be progressing in your field

on some other stream so that you can show

that you are moving forward

and learning those skills.

But then you also have to be working

on that trial in the background

because you know it's

going to take 2, 3, 7 years

for you to then get that data

and put that data out

there and analyse it.

And I think that it's a

barrier we kind of forget about

because time just keeps moving.

- I really appreciate you bringing this up

and we sort of have gone to

what I was gonna ask about next,

which is you're all involved in ISTAART

and we all share that

we are IMPACT-AD alums,

shout out to IMPACT-AD, amazing programme.

These all seem like great

ways to get people skilled,

ready to conduct trials,

but you're also giving

some fantastic advice

about other practical steps

that people might take

or considerations for starting

as an early career researcher in this.

I will just add for myself,

I think a massive challenge to overcome

was just understanding all the

regulatory pieces of trials.

That could have been a year

or two of my career alone,

just getting up to speed on

all of the different regulatory bodies,

the differences between needing

an independent safety officer versus a,

you know, a safety monitoring board.

What your institutional

regulations might look like

versus things at the funding level.

So that was really overwhelming

for me and I did find,

you know, taking specific

coursework on that

was incredibly helpful.

From your own perspectives,

any other tidbits of advice beyond

what you've already talked

about for early career listeners

who wanna enter clinical trials?

Maybe we can start with you, Elisa.

- Yeah, sure, I think we

should talk about ISTAART

because I began my career at ISTAART.

So I was at reserve and resilience

professional interest area, the PIA,

and I was like doing the programme chair

and then communications

chair, so I got involved.

And as a early career

researcher from other country,

from Brazil, this involvement

with the leadership there,

like in the United States, in Europe,

was very important and I participated

in the meetings and the webinars.

They are very helpful,

the clinical trials PIA,

they have a lot of webinars

teaching this kind of basic,

and I think to engage

in this opportunities,

to engage in the PIA, in this case,

the clinical trials

PIA, is really helpful.

Other opportunity I engaged

that it was really important

was the Mentors Breakfast

and also the AWARE PIA.

So we are all women here again.

And there is this AWARE PIA at ISTAART,

they have this breakfast,

and you go there and you, like, listen,

you join with the, some,

you know, women that it's

a researcher, very famous,

or, you know, consolidating the field,

and you can talk a little

bit about these challenges

that you don't have opportunity to ask,

like in the talk or something like that.

And it's really important to not only

to understand the science,

but also what do you need

to do the science properly.

So I think that engage these communities

and go for and show up and don't be afraid

of getting risks that, for clinical trial,

it's a risk for from the beginning.

But believe, you know,

in what we're doing, with

the rigorous of the science.

- Awesome.

Elizabeth, what about you?

- Yeah, I think I have two

thoughts that really stand out.

The first is this idea of knowing your why

because things get really,

really, really hard.

And then like we mentioned earlier,

we have lots of internal

challenges and thought processes

that can slow us down or stop us.

So, if you really think about

and you embody your why,

that will help you overcome the barriers

and the challenges and the days

where you have to stay up till

one o'clock in the morning

to get a grant submission

in or whatever it might be.

My other thought to that is tied in,

but it's this idea of

seeing failure outside

of your own identity.

That failure is actually learning,

and we call them growing pains

because it literally is painful to grow,

but we don't learn and grow

without that level of failure

because I know those tests

that you failed or whatever,

that paper that got rejected,

whatever it might be,

some of those might be standing

out the most in your memory,

but then you learn and you grow

above that and beyond that.

So not having those

rejections and the failures,

whatever you might call that,

it's not tied to your

identity and who you are.

You are sound, you're

smart, you're brilliant

and doing great things in the world

to make an impact for

people who need it the most.

But it really lies into

our ability to be resilient

and overcome those hard times,

to stay focused on our why,

to help us carry through,

to be able to celebrate all the wins,

and the great opportunities

to connect to people.

To go into people's houses

and sit on their couch

and talk about how their

quilting is going, you know?

Those are the elements,

the humanistic side of

why we do what we do.

- Incredible advice, I

am officially asking you

to be a PIA mentor at this point.

Inga, let's end with you.

- It's a tough act to

follow, that was beautiful.

And I agree everything

that's been said so far.

So I think what I can add

is just also making

sure that you're trying

and putting yourself out

there and asking for,

it's not the easiest thing to

email someone or cold email,

but the field is just such a lovely place

where people are really excited to mentor,

they're excited to help.

And so, I think if there's

any kind of hesitation of,

I'm not sure, or imposter syndrome,

I know we talked a little bit about that,

just jumping over it, it

takes 30 seconds of courage

and just like build it up and

hit send and see what happens.

And so, I think it's getting yourself

a little bit of experience, even if it's,

you know, collecting data or

analysing the data with a team.

Those little aspects of

experience kind of build over time

and they compound and

then you're gonna build

that confidence and start

feeling more and more ready,

and then joining these

different programmes.

Really, I think those, the

different programmes in ISTAART,

so IMPACT-AD, ISTAART, all these things,

those are like the catalyst

to really bring you to the next level,

especially in this field.

And it's just a really collaborative,

beautiful environment.

- Fantastic advice.

(upbeat music)

So we are almost out of time.

Before we finish, I'd

like to end on something

a little bit fun.

I'm gonna ask that in

the interest of time,

you keep your answers to

just the research question,

but if you could run a trial

on absolutely anything at all,

no matter how unrealistic,

somewhat whimsical or silly,

what would you test?

So this could be the effect

of your favourite snack on productivity,

whether dogs and meetings

improve team morale,

or just anything that makes you smile.

So one research question,

and Inga I'm putting

you on the spot first.

- Well, I am a huge fan of dogs,

so actually that one

really resonated with me.

And honestly, I would love to see how dogs

just kind of impact people's ability

to live their best kind of life, you know?

So I know we're keeping it short.

- Awesome, fellow dog lover here.

Elizabeth.

- Yeah, I'm a music nut.

And we know that the music you like

from the ages of 15 to 25 is

the music you're gonna like

for the rest of your life, right?

So we can see that those

genre are generational.

So I listened to hardcore

rap when I was 16.

My grandpa is not gonna have

the same response to that.

If I could do a research

question or a trial,

it would really be to

look at the functional MRI

and the imaging and the

neurochemical release

of listening to your favourite song

from that generational era.

And what does that do in your brain

and how does that correlate

to behavioural response?

- The elder emo and me

loves that answer so much.

And last, but at least,

Elisa, what's your research question?

- Oh, my god, that's a tough one.

I would say that the

question the teachers ask me,

why some people don't learn?

So my research question was,

the best teaching strategy for adults

who are difficult learners, let's say.

And using this functional MRI

to understand their brains

while they are learning.

- Fantastic, well, thank you all so much,

Elizabeth, Inga, and Elisa

for joining me today,

and to all of you for listening.

As ever, you can find more information,

links to resources and

details on our website

at DementiaResearcher.nihr.ac.uk.

Do also check out our community app

where we continue these conversations

and share news, events,

blogs, and podcasts.

This has been an amazing discussion.

I feel like you've all shared

incredible information,

both as early career researchers

and those getting fantastic trials

off the ground and finished in some cases.

We heard about your dedication

to patient-oriented and

community-oriented outcomes,

your ability to balance

the rigour of trials

with things like more tailored,

individualised interventions.

We heard about mentoring networks

and how you might build them.

But I think what I'm taking away

is just this idea of all

of you taking chances

and putting yourselves out

there, taking those opportunities

that are in front of you to learn,

but also to, you know, really

grow in your own skillset.

So, so appreciative of your

willingness to share that advice

and that wisdom with all of us.

I am Annalise Rahman-Filipiak,

you have been listening to the

Dementia Researcher podcast.

Bye.

- Thank you.

- Thank you so much.

- Thank you, bye.

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