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

Alzheimer's, cardiovascular, and other chronic diseases; biomarkers, lifestyle, supplements, drugs, and health care.
Post Reply
Nevada
Contributor
Contributor
Posts: 10
Joined: Sun Mar 03, 2019 11:17 am
Location: Lincoln, CA

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

Post by Nevada »

Chicago Girl: Another helpful installment in your AHEAD journey. I also wish you had been negative or at least moderate in your Beta-Amyloid scan. Hopefully the MRI will confirm your continued elligibility for the trial. I have had 8 MRI's in the first 29 months AHEAD study and 1 for the previous and discontinued Generations study. The MRI's are reviewed by 3 parties: the local radiologist, the local study neurologist, and an independent neurologist (mine is at Mayo Clinic, Rochester MN). It should be noted that they don't always totally agree on the interpretation. According to my neurologist, local radiologists are not yet always attuned to signs of ARIA-E. Also the counts of verified microhemmorages verus possible or uncertain microhemmorages seen on the scan are not always the identical number by different raters looking at the same MRI scan (although they are pretty close). I await the next installment of your Journey.
User avatar
Chicagogirl
Contributor
Contributor
Posts: 93
Joined: Sat Aug 27, 2022 12:26 pm
Location: Southeastern USA

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

Post by Chicagogirl »

Nevada wrote: Fri Mar 31, 2023 3:40 pm Chicago Girl: Another helpful installment in your AHEAD journey. I also wish you had been negative or at least moderate in your Beta-Amyloid scan. Hopefully the MRI will confirm your continued elligibility for the trial.
Thanks Nevada, for your thoughts! Kind of expected that I would have Beta Amyloid, but one can always hope!
Hopefully I will know the MRI status this week.
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
User avatar
Chicagogirl
Contributor
Contributor
Posts: 93
Joined: Sat Aug 27, 2022 12:26 pm
Location: Southeastern USA

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

Post by Chicagogirl »

Documenting my journey:

Visit 4 - MRI - Results:
The MRI was read by the radiologist at the hospital, the study doctor at my site and Mayo Clinic and they all concurred: No significant findings, which means I am able to move to the final stage, Visit 5.

There is an optional sub-study available which is the Lumbar Puncture, where cerebrospinal fluid is collected. This is a clear fluid that flows in the internal spaces of the brain and around the brain and spinal cord. It is used to see how much amyloid is circulating in your spinal fluid.

Visit 5 - TAU PET SCAN has been scheduled along with the Baseline Visit for the initial infusion at Visit 6 - Week 0.

TAU PET scan will measure the amount of tau in my brain using a radiotracer called MK-6240. Tau is a second abnormal protein that builds-up in the brains of people with Alzheimer's. The radiotracer will be injected through a vein in your arm and then you will rest for 90 minutes, while the tracer travels to your brain. The actual PET scan will take approximately 20 minutes.

Visit 6 - Week 0 Will be given the first infusion of either the placebo or Lecanemab (BAN 2401). The first several infusions will be given at half the normal dose to make sure you don't have a reaction to it.

There will be a memory assessment, medical exam and then the infusion (which takes a little over an hour). There is a 4 hour observation time at your first infusion. You must stay in the infusion room the entire time. At my site you can bring a book, kindle, laptop, tablet, etc. or watch the TV's equipped with Netflix. They also suggest you bring snacks, etc which you can eat after the infusion is completed. My infusion visits (every 2 weeks) after this one will not have such a long monitoring time

Visit 6 - Week 0 means the 6th visit and the first infusion (0 weeks since the last infusion).

Visit 7 - Week 2 means it is the 7th visit and 2 weeks have passed since the 1st dose at Visit 6.

I've managed my feelings pretty well through this process since I knew in 2017 that I was e4/e4 and that I probably had Amyloid in my brain. I've read a lot and understand the risk of being in this trial,

BUT: For some reason finding out I was in this trial and would have the first infusion by the end of the month, rattled me a little. I also didn't expect to have elevated levels of Amyloid. I imagine most of you screening for or in this trial have felt the same way. As a friend put it: "We feel like we are guinea pigs or those little APOE4 mice running the wheel".

Just know you are not alone. There are many of us in this community, and we are all in this journey together. Till next time! Take care!
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
User avatar
Chicagogirl
Contributor
Contributor
Posts: 93
Joined: Sat Aug 27, 2022 12:26 pm
Location: Southeastern USA

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

Post by Chicagogirl »

Documenting my journey:

Visit 5 - (2-3 hours) TAU PET SCAN

This is the TAU PET scan to measure the amount of TAU in your brain using a tracer called MK-6240. The PET scan is a brain imaging test. TAU is a second abnormal protein that builds up in the brains of people with Alzheimer's.

After the injection of the radiotracer, I had to rest for 90 minutes. No activity during this period in a darken room. This means no reading, talking, checking phone or listening to music. It is very difficult to remain in a darken room with no stimulus for 90 minutes. Fortunately, there was a clock on the wall that I could see because of the ambient light that came in through the window in the door. The scan itself is very quiet and takes 30 minutes.

The radiologist reads it, then the study doctor before the scan is sent to the Mayo Clinic, where it is reviewed again.

I have already been accepted into the trial after the MRI results were available, so I am not sure if I will be given the results of this scan. It may just be a TAU PET SCAN to see how it correlates to the Amyloid Scan or just to provide additional information to the study.

I have completed the various visits and will start my infusions every 2 weeks (either the placebo or Lecanemab) This is called the baseline visit. The first several infusions will be at half dose to monitor any reactions to the drug.

Visit 6 - Week 0 - is scheduled before the end of the month. Week 0 is the baseline visit and means there have been zero weeks since my first infusion. Since I am in the AHEAD - 45 study (elevated amyloid) I will receive the infusion every 2 weeks after the baseline visit going forward.

So the first part of my journey is complete. Now starts the interesting stuff.

Just wanted to say again: Best wishes to all of you that have been following this thread and thanks to those who are participating in this trial. You are all warriors in this quest. Just know you are not alone. There are many of us in this community, and we are all in this journey together. Till next time! Take care!
Last edited by Chicagogirl on Sun Apr 16, 2023 8:08 pm, edited 1 time in total.
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
NF52
Support Team
Support Team
Posts: 2772
Joined: Tue Oct 25, 2016 9:41 am
Location: Eastern U.S.

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

Post by NF52 »

Chicagogirl wrote: Sat Apr 15, 2023 11:20 am Documenting my journey:

Visit 5 - (2-3 hours) TAU PET SCAN

This is the TAU PET scan to measure the amount of TAU in your brain using a tracer called MK-6240. The PET scan is a brain imaging test. TAU is a second abnormal protein that builds up in the brains of people with Alzheimer's.....

I have already been accepted into the trial after the MRI results were available, so I am not sure if I will be given the results of this scan. It may just be a TAU PET SCAN to see how it correlates to the Amyloid Scan or just to provide additional information to the study....

Visit 6 - Week 0 - is scheduled before the end of the month. Week 0 is the baseline visit and means there have been zero weeks since my first infusion. Since I am in the AHEAD - 45 study (elevated amyloid) I will receive the infusion every 2 weeks after the baseline visit going forward.

So the first part of my journey is complete. Now starts the interesting stuff.

Just wanted to say again: Best wishes to all you have been following this thread and thanks to those who are participating in this trial. You are all warriors in this quest. Just know you are not alone. There are many of us in this community, and we are all in this journey together. Till next time! Take care!
The results of the tau PET scans are not disclosed at this point, but I have heard from researchers that they will greatly advance understanding of when, how and where in the brain tau first occurs and then spreads in people with amyloid beta and normal cognition. It may be that differences will be found between females and males, or between people with and without ApoE4, or in different racial/ethnic groups.

Bioethiciasts, who consult on the trial design, consider non-disclosure an ethical decision not to disclose at this time, because the results would provide no actionable information to the participant (as opposed to disclosure of an MRI result o a micro-hemorrhage or a urine test showing a UTI. It's possible at the end of the trial that some info will be disclosed.

Welcome to an elite group, ChicagoGirl. As of February 2023, this trial was at about 50% enrollment. You're putting us into the "majority" milestone category!

Keep us posted on those infusions!

Nancy
4/4 and still an optimist!
User avatar
Chicagogirl
Contributor
Contributor
Posts: 93
Joined: Sat Aug 27, 2022 12:26 pm
Location: Southeastern USA

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

Post by Chicagogirl »

My Journey.......

Visit 6 - Week 0 (Baseline Visit)

This is the first or baseline visit where you will be randomly assigned to one of the two study groups;

Group 1: BAN2401 (active study drug) at 5mg/kg (dose based on weight). This amount will be given for the first 8 visits. Then it will increase to 10mg/kg of weight.

Group 2: Placebo (a saline solution that looks like the study drug).

The infusion takes place after the visit which includes some memory tests (not as many as before), a short neurological exam, ECG, blood pressure, etc.

The infusion takes approximately 60 minutes. Then you have an observation period of 4 hours to make sure you do not have any reaction to the medication. Then there is a blood draw at the end of the 4-hour period to determine how much (if any) is circulating in your blood.

The next couple of visits will only have a 2-hour observation period and then it will go down to a 1-hour period.

I am a hard stick so having my blood drawn or a drip line needle inserted is a struggle. Sometimes it takes 2-3 attempts to do it.

It took the nurse awhile to determine where to stick the drip line needle. While they are determining the spot and then sticking me, I try really hard to ignore them by letting my mind wander to my Happy Place, Jekyll Island. I usually walk the beach in my head and listen to the waves and the sea gulls. And then success!!! They are in.

After the hour they removed the saline bag, but left the needle apparatus in my vein and I watched a Netflix series on my tablet. It is really hard to spend 4-hours waiting. I got up a couple of times and walked around, but had to stay in the infusion room. A little after an hour into the 4-hour period, I got cold, then started shivering. Next came forehead sweats. The worst part was the dry heaves. This may not have been a drug reaction, just a reaction to receiving the saline. BUT it sure would be nice if it was a reaction to the drug.

The consent document says 10-20% of participants on the drug had a reaction. Those on the placebo had a 5-10% chance of a reaction. The reactions I had seem to be more indicative of an infusion reaction, rather than a drug reaction according to the information in the consent document.

I had brought a sandwich to eat for lunch but decided to pass. They brought me graham crackers and some ginger ale, which helped.

Around 3 1/2 hours into the observation period they came to stick my other arm to draw 1 vial of blood and then at the 4-hour mark I was a free person.

I will be interested to see if I have any reaction after the next infusion or if this was a one off. They did say they can pre-treat me (Benadryl) if I have a reaction after the second one.

I decided to go to the appointment by myself since it only takes 45 minutes to drive there. Along with my trip home my day was a little over 8 1/2 hours long. I went to bed early. Fortunately, the next visit has no memory tests and the wait time is only 2 hours - so in at 9:00 - out at 12:30. You can bring someone with you and if my drive had been longer, I probably would have.

If anyone in this study has had reactions, I would be interested in hearing about them.

Best wishes to all of you that have been following this thread and thanks to those who are participating in this trial. You are all warriors in this quest. Know you are not alone. Till next time! Take care!
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
User avatar
Chicagogirl
Contributor
Contributor
Posts: 93
Joined: Sat Aug 27, 2022 12:26 pm
Location: Southeastern USA

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

Post by Chicagogirl »

Visit 7 - (Week 2)

This was my second infusion (and the 2nd week after my first infusion).

This is a shorter visit than Visit 6. It only has a 2-hour observation period (rather than a 4-hour one) after receiving the infusion, which takes about 1 hour.

Only reaction this time was a headache.

As I mentioned in a prior post, I am a hard stick. It took 4 nurses and 5 attempts to get the infusion needle placed in my arm. But we had success. The nurses were concerned about how I was doing, but I really did not want to have to reschedule, so they tried the 5th time. They usually do not attempt that many times. Hats off to the team for not giving up. Hopefully they have figured out the best way to get the needle in my veins so the next visit is not so difficult.

I think that all sites have some of the problems that I have experienced during this journey. You just have to be determined and keep a sense of humor about all the bumps along the way.

Whether you are a participant in this trial or not, know you are all warriors in this quest to find a solution for all of us. Till next time! Take care!
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
Nevada
Contributor
Contributor
Posts: 10
Joined: Sun Mar 03, 2019 11:17 am
Location: Lincoln, CA

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

Post by Nevada »

Chicago Girl: Glad you are "sticking" with it! My AHEAD study coordinator reported that many centers are having difficulty retaining subjects. I suspect that this is due to many factors. Among them is the time committment and the fact that the changes or stability in cognitive status and drug effects, if any, are probably not noticible to most participants. In other words, you probably don't feel much different unless you have significant side effects or start to develop noticible cognitive impairment. For me, the compelling motivations are to advance the science, help others and maybe help myself. Since the AHEAD study is still enrolling participants, I will not know whether I was on Lecanemab or Placebo until more than 7 years after I began the study which was almost 2 1/2 years ago. I recently learned that Eisai and Biogen are submitting an application for an open label extension (enrollees could opt to receive Lecanemab at the end of their 4 1/2 years whether or not they received the active drug or placebo during the study). Hopefully, that will encourage more folks to stick with it. With FDA full approval of multiple drugs to treat Alzheimer's it will become increasingly difficult to run "clean" clinical trials with participants who have not received a drug before or choose to seek additional treatment during the trial. Nevada.
User avatar
Chicagogirl
Contributor
Contributor
Posts: 93
Joined: Sat Aug 27, 2022 12:26 pm
Location: Southeastern USA

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

Post by Chicagogirl »

Nevada wrote: Thu Jun 01, 2023 3:00 pm Chicago Girl: Glad you are "sticking" with it! My AHEAD study coordinator reported that many centers are having difficulty retaining subjects. I suspect that this is due to many factors. Among them is the time commitment and the fact that the changes or stability in cognitive status and drug effects, if any, are probably not noticeable to most participants. In other words, you probably don't feel much different unless you have significant side effects or start to develop noticeable cognitive impairment. For me, the compelling motivations are to advance the science, help others and maybe help myself.
Nevada: Thanks for your comments. There were times when I thought of giving up when it took almost 4 months to get the MRI and Scans going.

The time commitment is intense, especially since I am in the AHEAD 45 study, so infusions every 2 weeks. I take a swim class 4x a week, and exercise class 2x a week. Between that and my normal life, this study takes a lot of my time. The next visit requires an MRI the next day, before the full dose infusions start. I think there are several MRI's starting after that.

BUT, I feel like you.... this may benefit me or it may not. Friends ask why "Why do I do this? My answer is similar to yours. Additionally, both my parents had dementia and my mom lived with us almost to the end. I don't wish this on anyone, especially my family. I tell friends why I can't do something, so they come to understand that clinical trials are important. Most of them have had loved ones (parents or spouse) with this disease.

At some point there has to an answer to the Alzheimer's puzzle. If individuals don't step up to participate in clinical trials, how will we ever solve the puzzle. So, I smile at the nurses when they get upset at not being able to get the needle in and laugh with them over my vein situation. I decided that this study takes 1st priority in my schedule (unless my time is family related) and I just keep laughing.

Thanks for reaching out. It is nice to hear from someone also in the study.
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
User avatar
Chicagogirl
Contributor
Contributor
Posts: 93
Joined: Sat Aug 27, 2022 12:26 pm
Location: Southeastern USA

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

Post by Chicagogirl »

Visit 8 - Week 4 (3rd infusion) - This infusion is the 4th week since infusion at Week 0

This visit went well. Only 1 stick to get the infusion line in. Yeah, So happy!

Visit 9 is coming up this week. Then I have the first MRI. This is the first MRI after the 4 infusions at half dose.

Provided the MRI is stable, Visit 10 will be at full dose.

Whether you are a participant in this trial or not, know you are all warriors in this quest to find a solution for all of us! Till next time! Take care!
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
Post Reply