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

[Nevada]

Nancy, Thanks for posting all those changes and improvements to the AHEAD protocols. I hope that it will encourage more participation and better retention of participants. As you alluded, one important advantage of participating in an Alzheimer's study or clinical trial is establishing an ongoing relationship with a neurologist and center. My friends and aquaintances are finding it difficult to get an initial appointment with a neurologist. Sometimes they wait 6 months or more, and I live in an area with a relatively high numbers of medical specialists. This is going to be a significant challenge to the medical care system as more Alzheimer's treatment options receive FDA approval.

[squirrel320]

Ditto that, Nevada! Thank you Nancy for posting. I was one of those participants that Nancy referred to - I was positive on PrecivityAD, but my PET scan did not show intermediate or elevated levels of amyloid. Yay for that.... However, you still know that you have they positive blood test.....so you wonder how much below that threshold you were......

My blood test was done September 22, I was in for the PET Scan December 6 and received the results December 21. The site I worked with - Toronto Memory Clinic - was amazing. They did not think they could get the protocol appointment done before the holidays but managed to pull of an early morning appointment so that I had the news before the holidays - I had been more than a bit stressed admittedly about waiting until into January.

Nancy, thanks so much for sharing the updated sub-study. I have reached out to see if I am eligible for it at our site.

Chicagogirl, amazing decision to donate your brain to research. My biological aunt's brain, given her early age of onset at 51, was also donated to research. We learned that when she passed she not only had severe Alzheimer's pathology but also Lewy Body. I know her genes and brain will serve science well and plan on volunteering the same... when I am a little older

[Chicagogirl]

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Visit 27 - Week 42 (22th infusion)

Visit 28 - Week 44 (23rd infusion)

Both of these infusions were done by my Home Health Nurse and has become routine and easy.

Thanks to the following for their informative updates:

Nevada (2/7/24) for the update on the new consent form with the Open Label Extension Phase of the study;

NF52 (2/10/24) updating all the positive changes that have been made to the AHEAD trial;

Squirrel320 (2/21/24) who is following up on NF52 update and will probably be eligible for the sub-study, providing updated screening for those who screened but did not qualify for the AHEAD study clinical trial.

My site will be adopting the new consent form that was mentioned by Nevada. I imagine I will sign it at my next in person visit.

My next two visits will be as follows:

Visit 29 – Week 46 (24th infusion and MRI #6)

Visit 30 – Week 48 (25th infusion and Memory Tests, etc.)

My week 46 infusion will occur as a home visit (my choice) and then in the afternoon I will head down to the imaging site for my normal required MRI #6.

My week 48 will be done at the site. This will include the required memory & thinking tests, there are physical and neurological testing, ECG, Blood Work & Depression and Well Being Questionnaires. Will be informed that my MRI is normal, unless I have already been contacted by the center beforehand with any abnormalities. Then I will have my normal infusion there.

Study Partner - This visit also requires meeting with the study partner (my husband) to follow up on my memory and any issues that I may be having. A similar visit was done before my first infusion and acceptance into the study. The site has offered to do my husband’s part over the phone, so he does not have to spend the better part of a day at the site.

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!

[shug]

Thanks so much for starting this thread! It has helped me a lot just to read what you have been through and what may be in store for me.

I joined the donanemab study 2 years ago but fortunately the blood test showed no evidence of the tau marker so I was happily kicked out of it. I joined the lecanemab study a few months ago and they did find evidence of amyloid marker present so the next step will be to see if it shows up on the petscan.

I'll be following your journey. Thanks again!
Shari 4/4

[squirrel320]

Thanks so much for starting this thread! It has helped me a lot just to read what you have been through and what may be in store for me.

I joined the donanemab study 2 years ago but fortunately the blood test showed no evidence of the tau marker so I was happily kicked out of it. I joined the lecanemab study a few months ago and they did find evidence of amyloid marker present so the next step will be to see if it shows up on the petscan.

I'll be following your journey. Thanks again!
Shari 4/4

Ditto on the thank you to Chicagogirl for this thread. I was positive on the PrecivityAD2 test and yet my PET scan did not show intermediate or elevated amyloid. Best wishes to you during this time of waiting - I found it stressful and was so appreciative of my study site moving things along as quickly as possible. I am hoping you do not need to wait too long for an answer. The PET scan itself was pretty low key. A little weird - the need to be quiet for what seemed so long (!), being injected with something radioactive, the very particular timing between injection and scan, which was complicated in Canada by the uncertainty of the timing of getting the tracer across the border. I was very happy to be able to hopefully nudge the science forward just a tiny bit.

Take care and be good to yourself,
Sheri

[Chicagogirl]

Thanks so much for starting this thread! It has helped me a lot just to read what you have been through and what may be in store for me.

I joined the donanemab study 2 years ago but fortunately the blood test showed no evidence of the tau marker so I was happily kicked out of it. I joined the lecanemab study a few months ago and they did find evidence of amyloid marker present so the next step will be to see if it shows up on the petscan.

I'll be following your journey. Thanks again!
Shari 4/4

Ditto on the thank you to Chicagogirl for this thread. I was very happy to be able to hopefully nudge the science forward just a tiny bit.

Take care and be good to yourself,
Sheri

Thanks so much for your comments about these posts. I know that when I was in the Generations Clinical Trial starting in 2017, I had no clue how trials worked. That one was easy though, show up every three months, get your pills and periodically do an MRI. Also, there wasn’t as much information on the internet where you could research the trial (or I just didn’t look hard enough). I did find on this APOE4 forum a group of four other women in that trial, and we became what I call our Tribe.

This trial was different. Infusions are more invasive, and the drug comes with more risks. If you have elevated amyloid like I do it requires infusions every two weeks and numerous MRIs to make sure you are safe. I never found anything from a participant perspective of what it meant to be in a trial and felt a need to write about it. Clinical trials can be scary and as a participant you have to research and decide on your benefit/risk ratio. This thread does not address the risk of going into this trial. There are other threads here that address that. This is simply a record of a journey of going through this trial.

Your comments about the tread are heartwarming to me. I know there are a number of views on this post, but what I really wanted to know was did this thread make a difference to anyone.

So… Thank you for your comments and the comments of those who were already in the trial and posted here. Their insights in their journey have been helpful. We need ways to support each other, whether in a trial or not.

We are all warriors ( a Tribe ) in a fight against a terrible disease.

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 AKA Lois

[shug]

Thank you all! And Sheri, I hope that THIS Shari has the same petscan news! Although I realize that's not likely. I have to say I was not surprised that amyloid marker showed up in my blood, because I believe I read that most 4/4's have amyloid years or decades before symptoms. I'm a working veterinarian at a busy practice and am only 57 years old. I am not sure I'll be able to take off so much work if I have more than intermediate amyloid... every 2 weeks will be tough for me.

[Chicagogirl]

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Visit 29 – Week 46 (24th infusion and MRI #6)

This infusion occurred as a home visit (my choice) and then in the afternoon I headed down to the imaging site for my normal required MRI #6. The Home Health Infusion Nurse arrived on time along with the delivery of the drug/placebo from the Center’s Pharmacy. The results from this MRI showed no issues so I was cleared to continue.

Visit 30 – Week 48 (25th infusion and Memory Tests, etc.)

For this visit I drove down to my Study Site and met with the Center’s Nurses. I had a neurological exam, memory tests and an ECG, along with necessary blood work. The center has gotten better at inserting the infusion line, but many times they go into the snuff box area on my hand. Because of where it is, they need to wrap it well to make sure that I don’t accidently cause it to pull out.

This visit also requires meeting with the study partner (my husband) to follow up on my memory and any issues that I may be having. A similar visit was done before my first infusion and acceptance into the study. The site offered to do my husband’s part over the phone, so he did not have to spend the better part of a day at the site.

While I was doing my memory tests a call was placed to my husband to ask about my memory, any issues I was having and any events we had done recently. Then this same person called me (she was working remotely) to ask basically the same questions to see how we matched up in my assessment of my memory.

I arrived at 9am and left at 1:30pm.

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!

Lois (Chicagogirl)

[Chicagogirl]

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Visit 31 – Week 50 (26th infusion)

Just to let you know there some is flexibility in scheduling your appointments. I personally try to stick to a Monday infusion every two weeks. I am pretty busy, so it is difficult to wait till the last week or so to schedule an infusion appointment. This way I can plan other activities I do around that and my Home Health Nurse (who works at a hospital 3-4 days a week) can plan her work week around the appointments. This visit was moved to the Friday before so that she could travel to Ohio to see the eclipse. Can't wait to hear how it felt to be in a total eclipse area. I also have flexibility to move my appointment 4-6 days before and/or after the normal scheduled date. This way if you want to take an extended vacation somewhere you can.

UPDATED CONSENT FORM

I received a copy (by email) of the updated INFORMED CONSENT FORM FOR THE AHEAD-45 RESEARCH TRIAL.(Advarra IRB Approved Version 14 Nov 2023), Revised 25 March 2024.
I can review and ask any questions that I have.

I know that other sites have already processed this new consent by having participants sign it. I will sign it electronically after a review online with my study nurse at the AHEAD center. As mentioned by Nevada and NF52 there is an opportunity to switch to an optional extension period if my memory worsens during the initial period of the trial.

OPTIONAL EXTENSION PHASE:

If your memory worsens while you are participating in the study, or if you complete the study treatment period, you may be able to proceed to an Open Label Extension Phase of the study. Open label means that all participants will receive the active study drug. The study team can talk with you more about the Open Label Extension Phase of the study, and if you may qualify to join. You will have to sign another consent form if you choose to participate.

FOLLOW-UP PERIOD (Visit 85):

If you do not continue your participation into the Extension Phase, about 3 months after your
last dose of study drug in the Study Treatment Period, you will return to the clinic for a follow up visit. The follow-up visits can be split up across multiple days.

I am happy about the option to convert to the active study drug before the end of the clinical trial, if my memory worsens. Originally you were on the drug/placebo for 4 years. Hopefully, my memory won't worsen to the point of needing to go on the Optional Extension.

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!

Lois (Chicagogirl)

[Chicagogirl]

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Visit 31 – Week 50 (26th infusion) – UPDATE

So, there is one thing I should have mentioned in my last post:

Although I stared this journey on September 4, 2022, which was Visit 1A, there was a huge pause in progressing through the remaining various initial requirements.

My second visit which was the Amyloid PET scan wasn’t until February 22, 2023. After that came the MRI and TAU PET scan. Visit 6 (1st infusion) which occurred at Week 0 wasn’t until May 1, 2023 posting (Actual date April 25th).

There was a huge delay in getting my PET due to a new PET scanner not being available when they thought it would be. Additionally, there seemed to be problems obtaining the required tracer for the scan. The tracer issue seemed to be a national one. As I understand it this is not an issue now.

This visit at Week 50 (26th infusion) was my ONE-YEAR ANNIVERSARY.

It sounds confusing, but they label the first infusion Visit 6 as Week 0.

Thankfully, the process has become easier for everyone.

When I posted last week, it didn’t hit me that it was my 26th infusion so 52 weeks as you and I would look at it.

So hip hip hooray and a huge THANK YOU to my study site for putting up with my uncooperative veins and all my pestering questions.

From the doctor, receptionist, study nurse, the center infusion nurses, my home infusion nurse and all the various individuals that I have encountered (and those behind the scene) THANK YOU. I appreciate all that you do.

They are a wonderful group of people dedicated to slaying this dragon called Alzheimer’s, along with all the individuals working nationally in this field.

I am one year closer to infusions going from every 2 weeks to every 4 weeks. Can’t wait!

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!

Lois