Welcome to the seventh season of the Dementia Researcher X ISTAART PIA Relay Podcast. Across six episodes, leading early career and senior researchers hand the mic from one ISTAART PIA to the next, giving you an honest, peer-to-peer tour of where dementia research is actually heading, from wearables and biomarkers to policy and trial design, in the run-up to AAIC.

Series closer, and the relay comes full circle: Carla Abdelnour, who hosted episode one, returns as the guest. Carla is a clinician scientist in Barcelona and incoming Chair of the ISTAART Clinical Trials Advancement and Methods PIA, working on mixed neurodegenerative disease, particularly Lewy body and Alzheimer's pathology together. With host Sindhuja Tirumalai Govindarajan she explains why co-pathology is so common and what it means for treatment: does someone with both alpha-synuclein and Alzheimer's pathology respond to an anti-amyloid drug the same way as someone without? They discuss why she leans on fluid biomarkers, the wish for a synuclein PET tracer, and how trials might stratify or include people by co-pathology. Carla makes a useful point for anyone designing research, that clinical trial methods translate straight to observational studies, and previews the CTAM PIA's AAIC programme, including a panel and featured session on global representation in trials.

Takeaways

• Mixed pathology is common, and co-occurring alpha-synuclein and Alzheimer's pathology may change how people respond to treatment.
• Trials could stratify or include people by co-pathology, but alpha-synuclein is currently detectable only in CSF, which limits that.
• Fluid biomarkers offer the specificity to track different proteinopathies and, potentially, response to treatment.
• Clinical trial design transfers straight to observational research: the same inclusion criteria, outcomes and sample-size thinking.
• Global representation in trials is a live priority, with a CTAM panel launching at AAIC.

--

The Alzheimer’s Association International Society to Advance Alzheimer’s Research and Treatment (ISTAART) convenes the global Alzheimer’s and dementia science community. Members share knowledge, fuel collaboration and advance research to find more effective ways to detect, treat and prevent Alzheimer’s and other dementias. Professional Interest Areas (PIA) are an assembly of ISTAART members with common subspecialties or interests.

There are currently 30 PIAs covering a wide range of interests and fields, from Neuroimaging to Diversity and Disparities and everything in between.

Find out more at https://istaart.alz.org/

--

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(gentle upbeat music)

- [Narrator] Hello, and

welcome to season seven

of the Dementia Researcher

"ISTAART Relay" podcast.

In this series,

members of the ISTAART's

professional interest areas

interview each other about their PIAs

and the hot topics in their fields.

Each guest then becomes

the next episode's host,

passing the conversation along

from one researcher to the next.

We are releasing one

episode a day in the run up

to the Alzheimer's Association

International Conference,

this year in London and online,

showcasing the work of the ISTAART PIAs.

Thank you for listening.

(gentle guitar music)

- Hello and thanks for tuning in.

I'm Sindhuja Tirumalai Govindarajan.

I'm an Alzheimer's

Association research fellow

and postdoctoral researcher

at the University of Pennsylvania.

And over the summer, I'll be

transitioning into a new role

as an assistant professor

at the Karolinska Institute.

I also serve as the outgoing chair

on the Professional Interest Area

for Elevating Early Career Researchers,

it's shortened as PEERs PIA

and this is within the ISTAART.

Today, I'm delighted to be

talking with Dr. Carla Abdelnour

from the Clinical Trials

Advancement and Methods PIA.

Hi, Carla, welcome to the show.

- Hi, Sindhuja.

- To kick things off,

could you introduce

yourself to our listeners

and tell us a little bit

about your current work

and research focus?

- Of course.

My name is Carla Abdelnour,

I'm a clinician scientist,

and I work in Barcelona, Spain

at the Hospital de la

Santa Creu i Sant Pau

in the neurology department

in the memory unit.

My work focuses

on studying mixed neurodegenerative

diseases of ageing,

particularly Lewy body disease

with Alzheimer disease mixed pathology.

And what I want to do with my research

is to try to understand how

these proteinopathies interact

to develop better tools for diagnosis

and also for treatments of our patients.

- That's great.

That's such a massive space

at the intersection of two

very important questions.

How did you first get involved

in this area of research?

- Well, that's a great question, Sindhuja.

I started working on this

approximately 10 years ago

when I started my PhD.

And I developed my PhD on

dementia with Lewy bodies

with Alzheimer's disease mixed pathology.

This I was studying in dementia

with Lewy body patients

that have Alzheimer

disease profiles at CSF.

So, I studied different aspects

of this mixed pathology,

in particular, how this

patient progress over time

because they had faster progression,

that's our studies have shown also.

We studied how that,

the presence of ID capacity in DLP

influenced the clinical

presentation and atrophy patterns.

And all of that work was

done in collaboration

with the European Dementia

with Lewy body consortium,

which I'm very grateful

for their help with my PhD.

Then I moved to the US to do

my postdoctoral fellowship

with Professor Kathleen

Poston at Stanford University.

And there, I was able to include

Parkinson's disease patients

with cognitive impairment

that also have Alzheimer's

disease biomarkers,

so, then I will have the full

Lewy body disease spectrum

to study and understand the differences

and how the presence AD pathology

influence their cognition,

their disease progression in general,

function, global cognition, et cetera.

And also, try to study novel biomarkers,

in this case, plasma markers

and how to interpret them

in this setting of mixed pathologies.

So, it has been great,

working on this field for all 10 years now

'cause I have been seeing the explosion

and this awareness of the

presence of co-pathologies now

which is great, I'm excited to see

how many people now is

interested in this field.

And, yeah, so I started

working on my PhD on this.

It was a great opportunity,

at that time I was working

at the, at Fundacio Ace

as a neurologist, and

I got the opportunity

to join the European Dementia

with Lewy body consortium

and work on our dementia

with Lewy body cohort,

so that's how I dive into this field.

I have to be honest with you,

when I finished my

residency as a neurologist,

I was interested in stroke

and also movement disorders.

But, then I got in memory unit

and I fell in love with our patients

that have cognitive impairment

because it's so interesting.

Our memory, our behaviour,

that's what make us human.

And since I started neurology,

what I wanted to do is

understand our brain

and how the brain works.

So, understanding behaviour and cognition

is a great way to do that.

So, when I got the opportunity

to work on dementia with Lewy

bodies, it was my pure luck,

but I was super lucky

because I was able to combine my passion

about movement disorder,

so Parkinson's disease,

but also cognition.

And I always have thought about that,

with sometimes we make these

difference fields more,

a little bit arbitrary, right?

At the end there are all

neuro reactive diseases,

the patients are very similar.

It's just sometimes because of how the,

these diseases have been

described that we separate them,

but they're more similar than we think

and patients are very

iterative in general.

So, I'm very happy to be kind

of in both fields because we,

that way it gives me the

opportunity to learn from one field

and move the information to the other,

so have a different perspective, I guess.

- I think we're kindred spirits in that.

I did my PhD with a different

field of neurodegeneration

and moved to the field of ageing.

I worked on multiple sclerosis before

and there are a lot of commonalities

in terms of how the brain is affected.

And I could see like

the spark in your face

when you're talking about

how complex the brain is.

I agree with you that a

lot of the presentations

perhaps even are similar

across a diverse spectrum of diseases.

But exactly how we study them

is quite different, right?

So, for example, I'm

representing the PEERs PIA today,

but my area of research is

neuroimaging, mainly MRI focused.

And so, we're looking at how

the path mechanisms manifest,

how can we study them in vivo,

you know, before sometimes when

cognitive impairment present

sometimes during the

process along the continuum.

In terms of your specific research areas,

am I right in understanding

that you're focusing more

on the plasma markers

and as such the biofluid

markers and cognition?

Can you tell us about the methodologies

you use for your research?

- Yes, of course, definitely. Yes.

So, I have been analysing

biofluid biomarkers, mainly CSF.

More recently I also have

been study plasma markers.

And at the beginning

of my PhD I also will,

or during my PhD I also study MRI

for studying the atrophy patterns.

But, I think what my goal is,

is to work more on fluid biomarkers

because it's the best metrics, I guess,

to understand different dignopathies

and different processes,

so, that's why I'm very excited

that we are now able to

identify alpha-synuclein at CSF.

I remember doing my PhD when

we were not able to do that,

that is fairly recent,

and reading on the papers

at the end that said like,

well, what we need is alpha syn biomarker

and now we have it.

And that has changed our understanding

of these diseases also,

and the awareness as I mentioned before,

about the frequency of mixed pathologies

and all the implications

that that will have for our patients

and the treatments that

we decide for them.

So, yeah, I think I am

more inclined or, I guess,

I guess I biassed to fluid markers

because we can identify different proteins

that reflect the proteinopathies

but also the pathophysiological processes

that might indicate this

is progression or even,

I think I'm interested in

trying to find biomarkers

for monitoring patients,

or to see if we're able

to identify markers,

for example, for responses to treatment

or for better for prognosis or prediction.

And I guess biofluid markers

are very good for that.

But I'm happy to incorporate

other markers too

from, you know, imaging,

particularly I will be super happy

when we have a PET profile

Synuclein that will be great

to see alpha-synuclein clinging the brain.

I think that will be super exciting.

- That's great.

One cannot argue with the specificity

that comes from biofluid markers

and how complimentary they interact

with other biomarkers as

well, it's great to hear.

So, in your opinion,

do you think the more recent advancements

or discoveries that

you're so excited about

are adequately incorporated

in clinical trials?

Like what would you want

if you had a magic genie or a magic wand,

what wish would you want to

incorporate in clinical trials

to fix a current problem?

- I think that's a great question.

I think one of the things

that I'm very excited about

is to incorporate the identification

of different proteinopathies

in clinical trials.

Even for inclusion or exclusion

or for stratification,

I think maybe we can start

with a stratification.

And that is because there is this question

about what happens with a

patient with Alzheimer disease,

for example, receive a

treatment for amyloid or tau

but also have alpha-synuclein,

does that person respond

similar to a person that

doesn't have alpha-synuclein,

or labri by this, right?

So, I think this is a fair question

and I definitely would love

to see more clinical trials

trying to answer that question

as a secondary outcome

or exploratory outcome.

I understand the difficulties though

because, right now, the alpha-synuclein

is available only in CSF,

not all clinical trials have

as an inclusion criteria,

CSF is specifically, sometimes

only you can have the PET,

the amyloid or tau inclusion criteria.

And not all clinical trials in Alzheimer's

does either require biomarker

confirmation actually,

so, that's another thing.

But yeah, I think I

understand that it's not easy,

but even if in a sub group of patient

the clinical trials could answer that.

And I must say

that there are some great

setting clinical trials

happening on that space.

'Cause there are at least

two that I'm aware of

that are going to investigate

antiamyloid treatments

in patients that have

alpha-synuclein positivities

of level one disease.

And so I'm very excited about that

'cause it's the first time

that we're going to use a treatment

that has been developed for this field

of Alzheimer's one disease

and we're going to treat

a different population

that comes from the movement disorder,

also the Parkinson disease

with cognitive impairment

or dementia vulnerabilities.

And, so for me that means that

these fields are converging,

which is super good

'cause I think that cross collaboration

is going to teach us a lot of these.

And I think that's the best

way also to help our patients

'cause at the end what we want

is treatment for our patients

and we're going to meet

different resources

for different patients,

and for personalised

medicine we need that detail.

We need that level of detail

of how many proteinopathies patient has

in order to respond to the treatment.

- That's great.

Your excitement for the research topic

and for the future horizon is very obvious

from the way you can talk about this.

(upbeat music)

That's been really

helpful to set the stage

for what I want to talk about next,

which is the work of your PIA

with the clinical trials

and advancements PIA,

can I call it the CTAM PIA?

- Yes.

- Okay, great.

So, clearly it's a massive

interdisciplinary effort

with converging disease spectrums,

with converging proteinopathies,

diverging as well,

which is what makes it very fascinating.

So, how does your PIA organise itself

with the different experts from

statisticians to clinicians?

How are you organising,

how do you bring this work

together within the PIA?

- Well, I think that's

a very good question.

In our PIA we have

collaborative environment

and we're very open to any topic or idea

that somebody might have.

And we always try to encourage people

and help them and support them

in moving those ideas forward

because usually they are within

the objectives of the PIA.

What our PIA wants to do is we

want to develop better tools

for synuclein clinical trials.

And also we have a second objective

that has to do with

the education of people

about the design of clinical trials.

So, yeah, you're right, we're

very interdisciplinary PIA

and I think that's a strength

because we can learn from

different perspective,

and, yeah, so any idea that people have

and any of the members,

I invite them to collaborate,

if you have any idea

about something that you want to develop

either a webinar or a

different activity or a paper,

just reach out to us

where we will support you with your idea

and probably put you

in contact with people

that will help you.

- We will come back

to how people can get

involved in a second,

but just to take a step back,

I'd like to highlight a little bit more

what were the objectives

of the CTAM PIA in general?

I think you mentioned it already,

but maybe we need a specific segment of it

so the audience can know better.

- Yes. So, our PIA is on

clinical trials and methods.

And the methods part is,

I think, one of the very interesting ones

because what we want to do

is try to develop novel

methods or identify methods

for the clinical trials

for Alzheimer's disease

and related disorders.

And the second objective is

to educate people about the,

how to conduct clinical trials?

What are the best methodologies

that you have an idea

for a clinical trial?

Which I found fascinating and,

there have been a lot of

webinars and different activities

that the PIA has developed over the years

to support people in this regard.

Info transfer are very difficult to,

to manage and to perform.

But I think with the right

support that can be done.

So, again, if people are

interested in lome one,

just reach out to us.

- Did you get involved with the CTAM PIA?

What brought you here?

- Yes, I love that question.

It was during the pandemic.

I remember when I received

it, that email of invite us,

and I thought, oh my god,

that's such a great opportunity

because during the pandemic

I was working in Fundacio

Ace as neurologist

and I was heavily involved

in the clinical trial unit.

I was actually the deputy head

of the clinical trial unit

and I was coordinating

several clinical trials

and more than 100 participants

in clinical trial.

And during the pandemic what happened was

that we had that question, oh my god,

how are we going to cover clinical trials

in this situation, right?

All these protocols of these visits,

what are we going to do?

We have to adapt super

quickly to all of that.

So, I thought that that

will be a great opportunity

to reach out to people from

different parts of the world

and understand how they were

going to manage that situation.

It was a great opportunity in that regard.

I learned a lot from my

colleagues around the world

or how they were managing that.

Where after that it was

a great opportunity also

for networking.

I have been always

interested in clinical trials

because I'm a clinician,

and I want also been able

to develop better treatments

for my patients,

and clinical trials are the

best way to do that, right?

It helps me also being up

to date on the treatments

that are being developed in the pipelines

of the different neuroactive diseases.

So, yeah, I think clinical

trials are very helpful,

and as a researcher, it

also has taught me about

what is the best way to develop a protocol

for a research.

So, if you are a researcher

doing an observational study

or you have an idea of

an observational study,

learn about clinical trials

because that will be a great foundation,

that is the gold standard, I would say,

for developing protocol for any research.

It's the highest level

of scientific evidence,

so learning about clinical trials

is actually very helpful for your career.

So then, that was what

brought me to the CTMP

and has been an amazing journey.

- That's great, that's such

a great way to introduce

and highlight the

contributions of the PIA.

Could you tell me a little bit

about how it's organised

in terms of roles,

the structure within the PIA

and how new members can

potentially participate?

- Yes, of course.

So, we're in the process

of updating our executive committee,

and currently the vice chair, Rema Raman,

is the chair of our PIA,

she's been an amazing work

during the last two years

and I'm very grateful for her leadership.

And this year I will even

a new chair of the PIA

and we are waiting for the elections

'cause we have elections just recently

and we will have our new EC team,

which I'm, I'm looking

forward to meet them

either in person or virtually,

we'll have a virtual coffee if needed.

So, yeah, we're in the process

of building the new EC,

but we have had an amazing EC this year

and the the past period and

we have three working groups.

And so, we have a working

group on Lewy body trials

that I work on in collaboration

with the Lewy body dementia PIA.

We also have another working group

on diverse representation across the flow

and we have another one

about remote assessments

in clinical trials.

So, we have several working groups

and if people want to be involved

in any of these working

groups of have other ideas,

please reach out,

and I'll be happy to talk

with you about your ideas

and how to get involved more actively.

- Thank you, yeah,

I'm aware of some of the

programming you offer

because I think our PIAs

have been collaborating for

webinars or information sessions

even before I was part of it.

In terms of programming that's

related to the upcoming AIC,

what kind of sessions do you offer,

scientific, career development?

Could you share a little bit

about what new members or

interested parties can attend

or look out for at AIC?

- Yes. So during AIC, I encourage

people to come to the PRA.

There is going to be

an amazing discussion,

a panel discussion on

global representation

in clinical trials.

This is something that we

have been discussing a lot

during the past three years.

Rema and Jorge Libre,

Rema Raman and Jorge Libre

are leading that effort

with the working group

and that is going to

be a launch at the AIC.

And, so, please come to our PIA deck.

I think it's going to be

an amazing discussion.

And, in addition to that,

we have an FRS on the similar

topic on representation

that is led also by Rema.

I don't recall the exact details,

but, just reach out

'cause I haven't checked the

programme in detail just yet,

but, we're going to have

an FRS on clinical trials

from the CTAM PIA.

And I'll be in London,

so, if you have questions

about how to get involved more actively,

we're always asking for

members input or ideas.

We, I think we're very open PIA,

and one of the things that

we want to do for next year,

in addition to continue the

work from the previous EC

is to continue the

increase of the engagement

of the members,

in particularly, the early career members

that might be interested

in clinical trail design or methods.

So, yeah, reach out to

me, I'll be happy to,

to give you my contact

then we have, can have

more personal discussion about your ideas

or how to get involved.

- Great.

I particularly like your mention

of early career researchers

because that's the objective

of my PIA, which is PEERs PIA,

that I represent.

In terms of easier involvement,

you also have an EC position

for early career researchers, right?

- Yes, that's correct.

- Can you-

- Yeah.

- Although the elections

are done for this year,

can you tell us a little bit

about what kind of

activities have those ECR

executive committee members

gotten involved in in the past?

- Yes, in the past the is,

there literary researchers have

been involved in helping us

with the, in review webinar.

And that year actually the,

we used to do two segments of

that within one webinar talk,

but, because we want to talk

about pharmacological trials

and non-pharmacological trials.

And as you can imagine,

Sindhuja, that's a lot of work.

But people have done an amazing work.

I remember last time it

was Erina who took on the,

from trials I remember,

and I'm very sorry 'cause I

don't remember the other person,

but, I think, it was an amazing

summary of what has happened

because clinical trials is

such a big field, right?

There are a lot of clinical trials

happening within one year, so.

I think, but, I think

it's a good opportunity

for being up to date of what is happening,

and I think we are going

to continue to do that.

In addition, I think also

we might want to consider

discussing novel methodologies,

not only focusing on the chemical trials

from the pharm or non-pharm side,

but also what are new methodologies

that people are developing

for designing clinical trials.

- [Sindhuja] So,

so in what ways do you

think the methodologies

or techniques that you use

for clinical trials different

from what's used in research studies?

Like what are the challenges

that one might not know about

if they've only been exposed to,

you know, research

prospective studies like that?

- Yes, I think that's

a very good question.

I guess, well, the clinical trials

since they are organising different phases

and each phase has some main objective,

you will identify your outcomes

depending on the phase that your studies.

So, for example, if you are

conducting a phase two trial

where you want to study

safety and tolerability,

your outcomes will have to reflect that,

although you can incorporate

as a secondary outcomes,

cognition function or other

aspects that your interest,

for example, biomarker changes

as an exploratory markers, et cetera.

Now, when you have a project

or a research question,

you will be designing your methods

for answering that

specific question, right?

You are going to design your experiment

to answer that question

and you will identify

what are the outcomes

that I have to measure to

answer my research question.

What I think might be similar

between two approaches

is how to develop the

protocol, for example,

you will have to identify

what are the occlusion

and inclusion criteria

for their subjects.

You are going to have to identify

all the outcome measures

and describe them.

You have to calculate your sample size

to know you have enough people

involved or samples or X

to answer your research

question, which is very important

in both clinical trials

and research studies.

And so, I think having all

that prepared beforehand,

before doing the actual

study is super helpful.

So, I think the way that

clinical trails is structure

is translatable the most part

to observational studies,

has a similar to-do list.

This is when you are designing

an observational study.

- Clinical trial design is very complex

and interdisciplinary it looks like.

You previously mentioned

what you would like to see

ideally in a new clinical trial

with the incorporation of

like a magic wish of PET alpha-synuclein.

But, in terms of recent studies

that have shown success,

is there a particular study

that sounds very exciting

to you, very promising

that you want to see more of?

- Such a good question.

So, do you mean research study

or a clinical trial in particular?

- Clinical.

- A clinical trial?

- I mean a clinical

trial in specific, yeah.

- Yes, yes.

So, I went to ADPD recently in Copenhagen

and they presented a clinical trial

that is going to investigate total a map

in people with Lewy body.

So yeah, I'm very excited

about that clinical trial.

It is a phase two trial.

It has been done also collaboration

with the Lewy Body

Dementia Association and,

and that has been an

effort that has been led

by Charles Shaw from Stanford

and Dokavaskov from UCSD.

So, I'm very, yeah,

super happy to see that.

'cause I just, I just, I need to know,

I need to know if this, this,

these treatments also

work in the population

of data clinical phenotype

that is for samples

Lewy body disease, but have

the percents of amagoic data.

- Thank you for sharing that.

(upbeat music)

What advice would you have for

someone who is new to ISTAART

or Alzheimer's Association in

general in this field of work?

How do you think it has helped you

to be involved outside of

research advancements alone?

- Yes. I think that's a

very important question.

I will say reach out to

members from different PIAs

from your main interest.

I think people is very open

to extend their experience,

so, if you reach out to people

and ask them about their experiences,

if you are interested in

getting involved more actively

in any of the activities,

just reach out to people.

Also, you can reach out

to the Alzheimer's Association

and the PIA directly.

I think their leadership team is amazing.

They, they're doing an

amazing job helping us

to build this network of

collaborators across the world.

So, you have any questions,

I think that's also a great resource.

There is a lot of information

on the PIA website

about the different PIAs if

you want to check that also,

because there are a lot of opportunities

and you might have different interests,

not only on one field,

but different fields.

And you can definitely be a member

of several PIAs at the same time

and different working fields too.

I will also say that it's

an amazing opportunity

to meet people, to discuss ideas,

and at the end, to move the

field forward, Sindhuja,

because this is such a complex problem.

We want to develop

better diagnostic tools,

a better treatments for our patients.

And we're not going to do that alone,

we need a big team, a global team.

And the Alzheimer's

Association with the PIAs

are doing that.

So, I'm very happy to be part of the PIA,

and I will say that if you

interest, just reach out.

We need more people

working on this problems,

more ring trying to

answer these questions.

So yes, just come onboard

and help us to end dementia.

- Well said, we cannot do this alone,

we have to work together on that.

I think that is a fantastic

wrap up for the podcast so far.

Thank you all for listening.

This is the last show

ISTAART PIAs are a great

way, like Carla mentioned,

to expand your network,

find new collaborators,

and learn more about

Alzheimer's and dementia field

in general.

We hope that these podcasts

have inspired you to get involved

and you can find the profiles on myself

and our wonderful guest, Carla,

and information on how to

become involved in the ISTAART

on our website at

dementiaresearcher.nihr.ac.uk,

and also at www.alz.org/istaart,

or, for simpler terms, Google ISTAART

and it'll take you there.

We're looking forward to seeing

you at the AIC conference,

so, if you haven't already registered,

visit alz.org for more information

and come find us and say hello.

Thank you. Bye.

- Thank you. Bye.

- [Narrator] You have been

listening to the "Relay" podcast,

delivered as a collaboration

between Dementia researcher and ISTAART.

This podcast is made at

University College London

with generous funding from the

NIHR, Race Against Dementia,

Alzheimer's Association,

Alzheimer's Research UK,

and the Alzheimer's Society.

Please like and subscribe

and share your thoughts in the comments.

(gentle upbeat music)