AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

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gettingaheadofit
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by gettingaheadofit »

Many thanks to Nancy, Lois & Nevada for the support you instantly offered me. And also to anybody else who’s contributed to this topic: I read it all.

It turns out although I’ve struggled with many things (and my apoe status qualifies me for this cohort we wouldn’t sign up to be a member of 😬) and am justifiably concerned:

**I did not have enough amyloid show up in the PET scan to continue with the trial.** This surprised me.
But of course I’m grateful.

Weeks ago:
While waiting for my PET scan I was given a private room with a humorously giant reclining barcalounger, like you’d see in a new movie theater. The guy saw me setting up my book and my phone to scroll through, etc. I was surprised later to read online that in preparation for this type of PET scan the images are better if we’re not even reading (ie having a lot of brain activity) while we’re waiting for the radioactive tracer to do its thing (about 50 minutes).

The biomarker (protein?) showed up in my bloodwork long before the PET scan appt, which was what qualified me to get as far as I did in this study. I guess it’s possible to have the protein in the blood and still have plaque, just not enough to be considered an intermediate or elevated level for this trial.

to anyone reading this who is learning about and considering the study: I’m SO glad I did this & got this information. It’s very motivating. I was treated well.

The whole process unfolded over many weeks - 3 + months for me - so if I were to advise anybody who might be sitting on the fence: things can move quite slowly and it doesn’t hurt just to get one’s self in the system. I actually found it all fascinating.

While I did not have enough amyloid to continue with the study,
they still tested my memory for about 45 minutes
(shopping list, visual memory, versions of previous tests)

& quickly took 8 small vials of blood in the earlier part of the appointment before the disclosure to me at the end.

So maybe they’ll use it or store it for other research, who knows. They said something about using it to look for other bio markers. I asked about Klotho but they hadn’t been told about it being a part of the research.

The range of strong feelings I had (and still have to a much lesser degree) are not necessarily going anywhere. They’re just not overwhelming now, not rendering me quite as scared. More motivated, I’d guess. Knowledge is power. I don’t think I have a pass on all of this, and I’m very open to other studies/clinical trials.

And it turns out my study partner, a good friend, has decided to participate. So if she makes it past the blood test, I may have more to contribute to this subject as I experience this with her.

I saw a black coat with this saying written in white on the back:

Get busy living, or get busy dying.



Jennifer
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by Chicagogirl »

gettingaheadofit wrote: Tue May 21, 2024 3:40 pm Many thanks to Nancy, Lois & Nevada for the support you instantly offered me. And also to anybody else who’s contributed to this topic: I read it all.

**I did not have enough amyloid show up in the PET scan to continue with the trial.** This surprised me.
But of course I’m grateful.

And it turns out my study partner, a good friend, has decided to participate. So if she makes it past the blood test, I may have more to contribute to this subject as I experience this with her.

I saw a black coat with this saying written in white on the back:

Get busy living, or get busy dying.

Jennifer
.
Jennifer

It is a hard pill to swallow when you want in a study and are refused. But the wonderful news is that you are not to the point of needing it.

We need to hear from individuals that are going through this, so I thank you tremendously for posting about your experience. It does seem to take longer than it should to get to the point that you are at. Something I hope gets fixed in the future.

I saw where you mentioned “Klotho”, of which I knew nothing about. So, thanks for mentioning this. When I researched this, I did find that rigorous exercise increases this hormone in your body, which is helpful for delaying aging. I will work harder at my swim and exercise classes to increase this.

I was surprised about your comment about not being told about the PET scan protocol about not reading, listening to music, etc. I was placed in a small room where they turned the lights off and left me with no stimulation. The door did have a frosted glass window, so I could at least see the clock on the wall. Maybe they have changed the rules.

You are a brave soul to go through this. So many individuals just live in fear. I always felt that I needed to embrace my APOE4 status and figure out what to do about it. You have done this and started down a journey to help yourself.

Your closing statement says a lot about your determination:

“Get busy living, or get busy dying”

Best wishes on your journey and keep us posted.


Chicagogirl
Last edited by Chicagogirl on Wed Jul 03, 2024 6:11 am, edited 1 time in total.
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by Chicagogirl »

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Visit 34 – Week 56 (29th infusion)

Visit 35 – Week 58 (30th infusion)


Both of these infusions were done by my Home Health Nurse. I can’t really express how wonderful and relaxing it is having these infusions done in my home. I know that not all sites have this option and that I am very lucky. For me, I never knew exactly when I would arrive at the study site due to traffic (even after checking WAZE and Google Maps). This meant that I had to increase my drive time by about 30 minutes to allow for accidents, traffic jam, stalled vehicles on the drive, etc.

Visit 36 – Week 60 (31st infusion) – Memory & Thinking Skills Test, Blood Tests

This visit was done at my study site. My Home Health Nurse was going to be on vacation, and I also needed to do the Week 60 Blood Work, Memory & Thinking Skills Tests, etc.

I seemed to have a little more problems with the memory tests this visit than before:

There is a test that has you look at pictures of people, pick a name you think “fits” and then try to remember their names. Then they flash their pictures on a tablet and ask you to pick their name out of 3 that is provided on a tablet.

The next one that gave me problems was “Have you seen this card before”. A card is presented (say Ace of diamonds). Then the next card is presented, and you have to press YES or NO if you have seen the card before. In the beginning this is easy. But as more cards are presented, it becomes more difficult. When I did the practice set, I got a number of BUZZER sounds, meaning I was wrong. I assume I had the same problem when I did the actual test.

I also seem to have more problems with the Grocery list this time. The study nurse reads you 20 grocery items and asks you to repeat. Then reads the list again twice and ask you to repeat after each time. I remembered more items after each reading.

At the end of all the tests the study nurse asks me to repeat the Grocery list that was read to me at the beginning of the visit. I struggled with this and probably only got 8-9 items.

This could just be an OFF day, or it is an indicator that my memory is slightly worse and that I may be on the placebo.

Either way I am NOT going to stress about it. It is, what it is.

I will just keep doing my swim aerobic classes (2-3X week), my exercise class (2X week), monitor what I eat and do activities that force my cognitive reserve to stretch itself.

I also had my blood draws and then the infusion. I showed them a little bump on my arm where the Home Health Nurse does the placement of the infusion line (a little to the left of the bump). They were actually successful!!! I was the only one there Friday (I think this is a slow day and also my infusion didn’t start until 11am.

Signing of the New Consent (Advarra IRB Approved Version 16 Apr 2024):

My study nurse tried to have me sign the consent a couple of weeks ago electronically, but for some reason when it pulled up it was blank. So, I signed a paper copy at this visit.

Here is the important part of this consent:

"If your memory worsens while you are in the study or if you complete the study treatment period, you may qualify to join an open label Extension Phase. In the Extension Phase, all participants receive the active study drug (BAN2401)."


So, my journey continues……..

Whether you are a participant in a trial, or not, know we are all warriors in this quest to find a solution for all of us!

Till next time! Take care!

ChicagoGirl
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by Chicagogirl »

.
RECRUITMENT IS CLOSED IN THE AHEAD 3-45 STUDY

Wanted to let you know that the study has reached/ OR is about to reach their planned participation total.
The Clinicaltrial.gov site shows that the study is still open, but the Study’s website has a red banner at the top of their page that recruitment is closed. Visit the website listed below or see the attached picture.

https://www.aheadstudy.org/

If you are CURRENTLY screening for the trial this should mean that you are included in the 1,400 planned participants (If you meet the required criteria). It can take four to six months to have all the screening done. I am assuming they are including those in this stage in their decision to close recruiting. They will not be accepting NEW participants to be screened.

If you have questions, ask your Study Coordinator at the Study Site.

THANKS to all who shared their experiences on this forum. Hoping that others join this thread and let everyone know how your experience went. The purpose of this thread was to allow individuals to know what happens in a trial.

Keep us informed as you progress through the rest of your VISITS.

Hopefully with the 1,400 participants (those currently in the study and those who are in the screening process) they will be able to start forming opinions about the safety and the effectiveness of lecanemab for the PREVENTION of cognitive impairment. It will take a while for the preliminary results to be available. I will continue to post about my progress.


So, my journey continues……..

Whether you are a participant in a trial, or not, know we are all warriors in this quest to find a solution for all of us!

Till next time! Take care!

ChicagoGirl


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Last edited by Chicagogirl on Sat Jul 06, 2024 7:08 pm, edited 3 times in total.
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by MaggieMay »

Hi, everyone

I just discovered this forum today and am excited to read through all the posts. I have been in the trial for three years, and have an older sister who is also in the study. Two of our sisters did not have enough amyloid to qualify.

I probably am getting the placebo, since my only side effects are fatigue after the infusions and occasional chills. But perhaps I will read through the posts and discover similarities with people who think they might be getting the drug. I have already informed my liaisons that I want to get the real drug when it is offered to participants who have included the study infusions, so I have a lot more time to devote to this.

I am going to catch up on posts now. Looking forward to reading about everyone’s experiences.
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by Lyre Taylor »

MaggieMay wrote: Sat Jul 06, 2024 8:41 am Hi, everyone

I just discovered this forum today and am excited to read through all the posts. I have been in the trial for three years, and have an older sister who is also in the study. Two of our sisters did not have enough amyloid to qualify.

I probably am getting the placebo, since my only side effects are fatigue after the infusions and occasional chills. But perhaps I will read through the posts and discover similarities with people who think they might be getting the drug. I have already informed my liaisons that I want to get the real drug when it is offered to participants who have included the study infusions, so I have a lot more time to devote to this.

I am going to catch up on posts now. Looking forward to reading about everyone’s experiences.
Hello and Welcome!
I am so glad you have joined. It sounds like you are dedicated to learning as much as you can. You have found a like-minded community here on this site. We strive to learn as much as we can about prevention of Alzheimer's disease.

If you haven't already checked out apoe4.info, as a Support Team Intern I'm happy to share several tools & resources to help you get the most out of your experience here. The Primer is a detailed and informative resource written by a practicing M.D. with ApoE4/4. It includes information about the biochemistry of the ApoE4 gene and offers a variety of research-based prevention strategies.

Some helpful tips to navigate the site include the How-To Guide. It includes topics such as navigating the forum, private messaging, and searching. One great tip is using the quote (") button when replying to a post. Using the button will automatically alert the member of your response.

Wiki Main Page contains a wealth of information.

If you are interested in learning more about other members check out Our Stories.

Again, I am so glad you joined our forum. Stay positive and curious. Please feel free to reach out anytime.

Warmly,
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by shug »

I am also in the AHEAD study and had a positive on the C2N biomarker for amyloid. But happy to say that I got kicked out of the study today because my petscan showed no amyloid. Feel like I won the lottery! I’m 58 and a 4/4
-shari
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by NF52 »

shug wrote: Wed Jul 17, 2024 11:22 am I am also in the AHEAD study and had a positive on the C2N biomarker for amyloid. But happy to say that I got kicked out of the study today because my petscan showed no amyloid. Feel like I won the lottery! I’m 58 and a 4/4
-shari
Enjoy your lottery win, Shari! A happy dance is also in order. For those wondering how it can be that the PrecivityAD blood test can be "positive" and the amyloid PET scan negative, here's the explanation from the company, which comes down to "we don't want a test that is 100% certain to predict a positive PET scan, because we'd be excluding people who might have one, but it's not certain." Because they factor in ApoE 4/4 status, you may have been given some "bonus points" that you showed weren't needed!
RESULTS

The area under the receiver operating characteristic curve (AUC-ROC).. for the PrecivityAD2 test output, the Amyloid Probability Score 2, was 0.94, yielding 88% agreement with amyloid PET. Diagnostic performance of the APS2 was similar by ethnicity, sex, age, and apoE4 status.
https://alz-journals.onlinelibrary.wile ... /alz.13764
4/4 and still an optimist!
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by squirrel320 »

shug wrote: Wed Jul 17, 2024 11:22 am I am also in the AHEAD study and had a positive on the C2N biomarker for amyloid. But happy to say that I got kicked out of the study today because my petscan showed no amyloid. Feel like I won the lottery! I’m 58 and a 4/4
-shari
Woo hoo and Yay!!!
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by Chicagogirl »

shug wrote: Wed Jul 17, 2024 11:22 am I am also in the AHEAD study and had a positive on the C2N biomarker for amyloid. But happy to say that I got kicked out of the study today because my petscan showed no amyloid. Feel like I won the lottery! I’m 58 and a 4/4
-shari
.
What great news Shari! And to think that in this instance, failing a test is good news!

Enjoy your lottery and keep us posted as time goes on.

Best wishes!

Chicagogirl.
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
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