0:00

Now, what is the impact for imaging facilities?

0:03

The primary, uh, impact is gonna be increased.

0:06

MRI scan volume.

0:08

So, uh, an MRI is required

0:10

by label at baseline, and it should be recent.

0:13

Um, the old label said within one year,

0:15

but now the new label has been changed to say recent.

0:19

I don't consider recent, uh, a one year, obviously,

0:22

so probably within a couple of months.

0:24

Um, in some institutions they're gonna sort of require it,

0:27

but others, just, if you, you've got it within a couple

0:29

of months, um, then you're good to go.

0:31

Then an MRI is required prior to the fifth dose, prior

0:34

to the seventh dose and prior to the 14th dose.

0:37

These are all at the high dose, um, categories,

0:39

which is 10 mgs per kg, um, administered

0:42

by IV infusion every two weeks.

0:44

So MRIs must be acquired prior to these.

0:46

These are scheduled MRIs.

0:49

The A UR guidelines also recommend, um, a, uh, an MRI prior

0:53

to the 26 dose.

0:54

That's at 52 weeks, so that's not on the lecan label,

0:58

but it is, uh, the recommended schedule.

1:00

So this is five MRIs here,

1:03

and then plus additional MRIs, non-scheduled MRIs

1:06

whenever the patient develops a new neurologic symptoms.

1:09

So if you assume maybe the patient might have five headaches

1:12

a year, you know, the neurologist is probably gonna order an

1:15

MRI each time and probably on an urgent basis.

1:18

So, you know, if you assume about 10 scans per year,

1:22

roughly, um,

1:23

and let's say there's 1500 treatment candidates in the

1:26

United States, we're looking at 15,000 new MRIs a year, um,

1:31

impacting imaging facilities in the US alone,

1:34

uh, throughout our country.

1:36

So this is a very big number.

1:38

Imaging facilities really need to be prepared

1:40

for the increased number of MRIs that they're going to see.

1:43

Now, another impact for imaging, uh,

1:45

facilities would be consistency, and that is consistency

1:49

and protocol field strength, and ideally with vendor.

1:53

Um, the protocol is very important.

1:55

So the required sequences, uh, as recommended by the, um,

1:59

the A SNR, uh,

2:00

Alzheimer's ARIA Study group is A-G-R-E-A flare

2:04

and A DWI, I can tell you at our institution,

2:06

we're just gonna do a routine brain.

2:08

Um, now some people may be doing an SWI as part

2:12

of their routine brain, and some neurologists may always

2:15

require an SWI, again, because of the increased sensitivity.

2:18

If that's the case, please do A GRE in addition to that,

2:21

because when you're doing therapeutic screening, you need

2:24

to do the count off the GRE.

2:26

So in your dictation, you would report the number

2:29

of micro hemorrhages you see on both the GRE and the SWI.

2:32

But just put a note in there that using the GRE

2:35

for the ARIA grading, um,

2:37

and then field strength, um, you know,

2:39

ideally really should be done on a three T or 1.5 T.

2:43

Um, and preferably maintain the same field

2:45

strength between each visit.

2:47

And then, you know, ideally if you can stick

2:49

with the same vendor, that would be, uh, wonderful.

2:51

But I know that that's not possible in a lot of cases.

2:54

Uh, at our imaging enterprise, uh, we, you know,

2:56

we are the largest outpatient freestanding IMA

2:59

enterprise in the United States.

3:00

We have 355 freestanding imaging centers that we read from.

3:04

So we, we have a big diverse, uh, fleet of scanners,

3:06

so we can't always maintain the same vendor.

3:09

Now, the other impact for imaging facilities would be an

3:11

educational initiative for a neuroradiologist, uh,

3:14

for training for, uh, aria.

3:15

We're gonna do ARIA training here in this webinar,

3:18

but, you know, ALS imaging is a good website, uh,

3:21

for additional information

3:23

and educational, uh, initiatives are also, uh, ongoing

3:26

through the A SNR and through RSNA

3:29

and through, uh, other educational

3:30

webinars and things like that.

3:32

Now, another impact is quantitative volumetric imaging.

3:35

We're already, um, at least in my area,

3:38

my clinical practice, I, my referers order this, uh,

3:41

for almost every dementia patient,

3:43

but in other areas, it's not ordered as frequently.

3:45

But this is a very useful, uh, AI tool.

3:48

It can allow you to track the hippocampal volumes

3:51

and it can help with automated ARIA screening report

3:54

and is also was used in some of the trials.

3:57

Um, the other implication

3:59

for imaging facilities would be the beta amyloid

4:01

confirmation, which is required prior to treatment.

4:04

Um, this, it can be done through lp,

4:06

which is covered right now,

4:07

but, uh, again, uh, amyloid PET would be a preferable way

4:11

for patients to be screened for a beta amyloid confirmation.

4:15

And, you know, we're hoping to see that

4:17

that will be covered in the near future.

4:19

Um, and then productivity ad

4:21

and also, uh, quest has a new, uh, blood test as well.

4:25

These are both blood tests at this point.

4:27

Um, uh, there's still some variability in

4:29

the reliability there.

4:31

And, uh, also no coverage as of yet for blood testing.

4:35

Um, now, uh, let's talk about ARIA reporting.

4:38

So Aria screening and follow-up can be reported manually.

4:42

Um, the neuroradiologist are, again, uh, very important

4:45

because it impacts the therapeutic decisions.

4:48

Um, it's, uh, in terms of the interest level, uh, for Aria

4:53

and Alzheimer's, it's very interesting

4:56

'cause the As NR American Society

4:57

of Neuroradiology has an a ARIA study group.

4:59

Um, there's about a thousand

5:01

neuroradiologist that come a year.

5:02

There's actually 2,700 that are members of the AS NR,

5:04

but about a thousand make it to the meeting every year.

5:07

And, you know, they thought that there might be a small

5:09

number who study they would sign up for the study group.

5:11

Well, it turned out 800 neuroradiologist

5:13

signed up for the study group.

5:14

Um, and then we sent out a poll

5:17

to all 2,700 neuroradiologists that are members of AS SNR

5:21

and of the responding poll neuroradiologists.

5:24

It turned out that 63%

5:26

of them we're interested in using an automated proprietary,

5:30

uh, computer audit detection, uh, screening software,

5:33

AI software for RA detection, longitudinal follow-up

5:36

and automated reporting.

5:37

So we will talk about that and look at that.

5:40

Now, automated RA reports are in active development right

5:43

now, uh, from, uh, some of the major vendors

5:46

and pending FDA approval.

5:49

So this is kind of what it looks like.

5:51

This automated segmentation for quantitative MRI, this is,

5:54

uh, the white matter overlay, which

5:56

Would you use for Aria e screening, uh,

5:59

on the flare sequence.

6:00

And the other input sequence would be GRE,

6:03

where you'll see automated, uh, detection of the foci

6:06

of micro hemorrhage.

6:08

Um, so this is the GRE beforehand.

6:10

You see these little, uh, foci of micro hemorrhage

6:14

and they can be very small.

6:15

And I'm, I'm not sure if you can appreciate this,

6:17

but there's actually two right here.

6:19

Um, and then there's a few more along

6:21

here, one here and one here.

6:23

And this is what it looks like

6:24

after the automated detection is applied.

6:27

Um, here's an REE case, automated detection, uh,

6:30

through quantitative, uh, MRI, again, RAE

6:33

and automated, uh, detection.

6:35

Here's an RAE with SoCal fusion case that is color coded

6:39

after it goes through the QMI software.

6:41

This was originally, um, so again, uh, it's very useful for,

6:46

uh, detection of, uh, RAE and RAH.

6:49

Uh, there are different screening reports, uh,

6:52

that can be, um, generated.

6:54

This happens to be one from, uh, one company where it will,

6:57

for aria e it will give you, uh, the, uh, the lesion burden

7:01

and the count, uh, what's new, what's enlarging,

7:04

what's shrinking over time for Aria E

7:06

and for aria H, again, the, uh, count

7:09

for Aria h the count is mandatory,

7:11

so it's very important here.

7:12

We'll do the same thing for superficial cirrhosis

7:15

and compare dynamically since the prior study.

7:18

So here's sort of a, uh, summary report here for REAE, um,

7:22

lesion one, it's giving the, uh, diameter and size

7:25

because this is what's required for the grading system.

7:28

Um, so you get the diameter, uh, for, uh, all four

7:32

of these lesions, and you get the

7:34

change from the prior study.

7:35

It tells you where it is, right frontal lobe.

7:38

Um, and then it gives you a severity score for Aria E.

7:42

And this is based on this criteria that we talked about

7:44

before, um, for mild, moderate, and severe.

7:48

Here's in our sample Aria H report, uh,

7:51

that is in development,

7:53

and again, counting the current micro hemorrhages, uh, uh,

7:57

as well as the baseline.

7:59

And you can get the change in the number.

8:00

So baseline had one,

8:02

and then there was nine new ones at the follow up.

8:04

Uh, imaging will tell you where they are in the brain,

8:07

and, um, and,

8:08

and again, we'll give you a severity grading, uh,

8:11

for both superficial cirrhosis and for micro hemorrhages.

8:14

So having to be moderate, um, for super, uh,

8:17

for micro hemorrhages and mild for superficial cirrhosis.

8:20

According to this radiologic severity chart.

8:23

This is another ARIA screening report from a different

8:26

company.