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

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

Post by squirrel320 »

Hello, this is my first post. I have been following many sections for sometime. On Friday, I received the news that I passed the 1A screening for the AHEAD 3-45 trial and will move on to 1B. For those that have been through 1B, I would appreciate any insights that you believe might be helpful. Thank you so much,
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by hollybourne »

squirrel320 wrote: Sat Oct 14, 2023 3:02 pm Hello, this is my first post. I have been following many sections for sometime. On Friday, I received the news that I passed the 1A screening for the AHEAD 3-45 trial and will move on to 1B. For those that have been through 1B, I would appreciate any insights that you believe might be helpful. Thank you so much,
Hello Squirrel320 -

As a Support Team Intern, I'd like to thank you for joining our site and posting in the forum! This is a caring and knowledgeable group and we are so glad to have you here. That is great news regarding passing the 1A screening for AHEAD 3-45. Participating in this research will hopefully contribute to one day finding a treatment to prevent memory loss due to Alzheimer's disease. I'm hopeful others on this subject can relay their personal experience with the AHEAD trial, as there seems to be quite a bit of informative sharing on this thread.

You mention that you've been following many sections for awhile, but I'd like to share a few tools & resources you may find helpful to get the most out of your experience. 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.

Again, we are so glad you are here and please reach out anytime!

Warmly,

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

Post by NF52 »

squirrel320 wrote: Sat Oct 14, 2023 3:02 pm Hello, this is my first post. I have been following many sections for sometime. On Friday, I received the news that I passed the 1A screening for the AHEAD 3-45 trial and will move on to 1B. For those that have been through 1B, I would appreciate any insights that you believe might be helpful. Thank you so much,
Welcome !

I'm sure "Chicago Girl" , who started this wonderful topic, will welcome you also.

But I'll jump in to share a little about my experience. This coming week will be my "Week 96" visit in AHEAD-45 with my 47th infusion preceded by about an hour of cognitive tests, blood work, an EKG, a urine test and a brief physical by the study site MD, along with some questionnaires for my husband, who only had to come to what was then called Visit 1 in October 2021 and the Year 1 visit in October 2022. The two-year mark serves as a repeat assessment of screening, so I also have had an MRI, Amyloid PET and Tau PET scan in the last 10 days.

Neither I nor the team at this free-standing clinical research center site know whether I am in the 50'% placebo "arm" or the 50% lecanemab "arm". I'm fine with that, because I understand that clinical trials have to be rigorously designed to test very specific, predetermined criteria. In short, I hope the AHEAD trial shows that it is both safe and more effective to clear amyloid from the brain before any cognitive impairment occurs. A clinical trial requires, I think, both a personal commitment and a sense of helping others. In my case and those of others I know of, it also means becoming a familiar part of a group of people who are passionate about findings treatments, who value patient safety above all else, and who never fail to ask how I am doing, share stories of their own families and make me laugh.

A little background, which you may know well. There's no hard and fast rule about what is considered "elevated" amyloid, and different studies use different numbers, but I believe AHEAD used 20-39 centiloids on an Amyloid PET scan as "intermediate" and 40 or above as "elevated". Having either intermediate or elevated amyloid does not in itself predict that you will develop Alzheimer's disease, which makes it different from having a positive biopsy for breast or prostate cancer, for example. It is, however, one of two current biomarkers, along with phosphorylated tau ("p-tau") which are seen in the brains of many people clinically diagnosed with Alzheimer's disease and have come to be viewed as "preclinical" signs of disease pathology that can occur for years or decades leading up to Alzheimer's in some, but not all, people. The older you are when you have biomarkers of amyloid or tau, the more likely it seems that you will die with that brain pathology, but not from observable dementia.

The current PreCivityAD™ test that you "passed" is FDA-approved and has about an 86 % accuracy rate in predicting a positive PET scan. It is possible that you could eventually have a PET scan that would come back with the news that you were below amyloid positivity. Whatever the final results, you will not be told the exact number, not because they are hiding anything, but because researchers don't know enough about how significant a difference between 10 centiloids and 15 centiloids is, or between 40 an 60. They do know that most people diagnosed with Alzheimer's dementia (not just Mild Cognitive Impairment) have levels of 100 centiloids or higher.

I heard I had "elevated" amyloid in March 2020, when results from a PET scan I had in 2017 (at age 65) as part of a clinical trial for people with ApoE 4/4 were shared with me. I was calm then, thinking "I expected that". It was only in 2021, when I began to consider joining the AHEAD trial, that the idea of having lived for at least 4 years with "elevated amyloid" in my brain, and a long list of relatives who died with AD or vascular dementia, left me feeling very vulnerable--as in suddenly in tears in a Planet Fitness parking lot! Luckily I talked myself out of that quickly and decided I was going to look at risks and benefits for AHEAD closely. So I think it's perfectly normal to have a range of emotions even at this stage, and to know it gets better as you learn more and know that this clinical trial and cognitive reserve (education, occupational challenge) , social connections, exercise, diet, purpose in life--all are valuable to you.

I started testing in fall of 2021 and began infusions just before Christmas that year. Lately, I've heard that in some sites there's a backlog of people coming through screening, so sites have up to 6 months to complete the process. That gives you lots of time to make an informed decision about doing this. Once I started, it became an easy routine every two weeks, especially once I learned that they had the flexibility to move my infusion day between Mondays and Thursdays and even skipped an infusion when I had COVID in 2022.

I talked about the risks of serious side effects with my supportive husband and was clear that for me, the risks of MCI and AD seemed much more likely at age 69 (now 71). Because "Alzheimer's disease" still conjures up images of people in late stages, it took me until this summer to share my elevated amyloid status with my three ApoE 3/4 adult children, who knew I was getting biweekly infusions, but hadn't asked for details. In retrospect, I should have known they would handle the news with great empathy and interest. You may want to talk with your "study partner" (spouse, friend, adult child) about what this test result means and clear up any misunderstandings they have, as in "having amyloid plaques does not mean I have Alzheimer’s dementia or am destined to get it. It means I am at a higher risk for it in the future." Your study partner and any adult children or family or friends you share your news about the AHEAD screening with may also have a range of emotions--from "great" to "sounds interesting" to "why are you doing this?" Know that they want the best for you, and may need to hear that this is important to you, even if concerning to them, and that you will keep them informed as you progress through screening and if you join the study.

These next suggestions are what I wish someone had told me two years ago when I had the 1B visit:
  • Some of these items may seem very easy. That's because they need to rule out Mild Cognitive Impairment for your baseline. Others may seem surprising, for example a screening of your emotional health to rule out serious mental health risks to you in participating. Enjoy these as mini breaks for your brain; they may come after tests that have you feeling like you're on a quiz show.
  • No one enjoys of tests of processing speed, verbal and visual reasoning, and memory, even if you aced school achievement tests. But they are just your personal Baseline and used as the very first data point in what for me is a 24 month plot of repeated smaller test sessions every 3 months, and I know that my performance is variable from time to time. They are looking at age-related norms, not Einstein norms.

    True Story: I totally bombed the very first test I was given because I was both anxious and misheard the directions. My attention went to "wait, what is this test about and wait, did I just miss that?" which meant my immediate memory went to zilch!! So when I could answer almost nothing, I wanted nothing more than to quit! Luckily the next test was easy and the one after that was not bad--and I realized I had set myself up by expecting to not have any problems. About six months later I had a similar test and did okay on it--surprising the tester who had seen my Visit 1 performance!
    • So tell yourself: This is not an audition; it's a data point for the next 4 years!"
  • You study partner will be asked questions about your thinking skills and daily living activities. I have a friend whose husband on one of the questionnaires described activities like golf, bridge, walks, restaurants that they had done together, while the wife mentioned an adult child with a viral illness, calling hours for a friend, etc. So your memories don't have to mesh perfectly!
  • This visit can feel like a marathon. It's perfectly okay to say that you need a 5-10 minute break to get up and stretch, visit the bathroom, have a snack and water/coffee/juice. Most of us cannot concentrate at high levels for very long periods of time. While each test is fairly short (5-10 minutes), you will know when you need to regroup. You'll come back mentally and physically refreshed and feel less bothered. [Tell your care partner to bring a good book, or music etc. They will only have a small portion of the time you spend busy.]
  • Feel free to ask questions about the Consent Form and any other issues. I spent an hour talking with the Study Site doctor before Visit 1, which might have been a record for a screening participant.
  • You probably know that you have to have an initial MRI and amyloid PET and Tau PET. If you have serious claustrophobia, the MRI can be tricky, but most places offer music piped in, and you can ask the MRI tech to let you know over their microphone when you are half-way through, have five minutes left, etc. I know of someone who had doctor's approval for a Valium before each MRI in a different study. I view the regular MRIs in the first six months as an amazing safety feature that previous trials showed was important in identifying asymptomatic ARIA--most of which is easily manageable, but which you will hear about from the consent forms and your team.
AHEAD 3-45 currently has several hundred people enrolled; we have a forum member who is in his 3rd year in the study. I hope your Visit IB goes well, and you do something nice for yourself afterwards. And know that we're always here to answer questions and as Chicago Girl says, tell you that you are a warrior for seeking to do this!

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

Post by squirrel320 »

Nancy, thank you so very much for your candid, empathetic and well drafted reply. It is very meaningful to me. I will write a little bit more in the coming week, but have a course project deadline in the morning that I am still finishing off! A bit about my story as I wait for the next turn of my project materials.....

I was adopted by two wonderful amazing parents and am the youngest of 5. I also at 19 met my biological mother and she became a part of our broader family. I was ultimately her only child, and I eventually became her caregiver. She was showing signs of Alzheimer's at 70 but we brushed them off as stress related. She was formally diagnosed at 72 and passed in March of this year at 75 - her deterioration was somewhat astonishing to both me and one of her sisters who was a close confidant and listener over the last years. My bio mom's next younger sister was initially diagnosed at 51 (yes, 51) passed in December 2022 at 66 after being non-responsive for over two years. My bio mom, as I lovingly called her, had declined to the point that sharing the news that her sister had passed would not be comprehended.

There is a family history comes from my maternal grandfather's side and, after genetic counselling, my bio mom was tested for the early onset determinative genes and happily failed that test! I am APOE 4/4 per 23andme and am assuming that will be confirmed as part of the AHEAD study. I am 55 at present so elevated amyloid at this point is of course very scary, particularly on the heels of my mother's rapid decline in the last year.

I am in Canadian so things may be a bit different as it relates to timing I expect. My bio mom and I were very much look-a-likes and seeing her progression was a bit like watching myself in the mirror. I am hoping that the devastation does not pass along at least to my son and grandchildren, that a cure of some kind is found.

Thank you again Nancy and to Chicagogirl for starting this post - my adoptive Mom was born there and I love that city!

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

Post by squirrel320 »

Thank you Nancy - your reply could honestly not have been more timely. Quite fortuitously, I just received a call that a 1B screening appointment opened up with a last minute cancellation - so from positive 1A result on Friday the 13th :lol: , to 1B screening this Thursday on the 19th! Thank you again - here is to hoping I pass 1B.....I guess or at least that I don't have to wait too long to know where I stand. It will be an early morning across the city to avoid the crush of traffic.
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by Chicagogirl »

squirrel320 wrote: Sat Oct 14, 2023 3:02 pm Hello, this is my first post. I have been following many sections for sometime. On Friday, I received the news that I passed the 1A screening for the AHEAD 3-45 trial and will move on to 1B. For those that have been through 1B, I would appreciate any insights that you believe might be helpful. Thank you so much,
Welcome Sheri!

You have started on a journey that I hope will bring you peace as you go through it.

When I joined a clinical trial in 2017 (age 66) and found out I was e4/4 I felt a sense of dread. I saw what this disease did to my mom, and I didn’t wish that on anyone. When I started that trial, no one knew except my husband and daughter. It has become much more acceptable to talk about Alzheimer’s and our experience with it. What helped me most was connecting with 4 other women on this forum that were also in that trial. (scattered all over the country). Our support and kindness for each other helped us during a time when there wasn’t much information on clinical trials and Alzheimer’s. To this day we still keep in touch, with two of us in this trial. This forum makes it easier to feel part of a “clinical trial” tribe.

Now in my 70’s I find myself in this trial. I have come to feel it is my mission to tell anyone who might be interested about Alzheimer’s. Even if they are not interested in joining a trial, it is good for individuals to know that it is ok to talk about it and that there are individuals who have the markers for it, but are still functioning in this world.

I’ve mentioned the trial to individuals who I take a swim class with and at a Senior Social Club. Two individuals I know are going through the testing to see if they qualify. I also provide links to Mind Crowd and the APT Webstudy (Test your memory every 3 months – see separate topic under Prevention and Treatment) for those interested in tracking their memory. I’ve referred some to caregiver groups when they are taking care of their spouse who has dementia. We also have GA MEMORY NET in my state (recently started) that directs individuals on where to find a diagnosis and recommendations on providers.

I know this doesn’t directly answer your question about getting through the trial, but NF52 has provided a great explanation and I especially love her statement:

This is not an audition; it’s a data point for the next 4 years.

I personally dread the memory tests since it makes me feel so small. BUT I have come to accept that they are necessary. As said above, they are just a data point in my journey in life. Acceptance of them have come with my knowledge that I am doing everything I can to avoid the disease my mom had.

Your tribute to your bio-mom and your willingness to become her caregiver at the end of her life is a wonderful testament of your character and strength. I also took care of my mom for 10 years, the last 5 being the hardest.

It does sound like you have the cards stacked against you, but I get a sense of determination to do whatever you can to tackle this possibility. I know that by participating in my first clinical trial and now this one has given me a sense of control over my life. I think the feeling like you are in control of your future (although we all acknowledge that in the end this disease can get us) allows us to feel normal and move forward and find ways to enjoy every day.

I told people that if the PET didn't show Amyloid, I would bring out the champagne and celebrate, not being in the trial. But I also said, if I had Amyloid, I hoped that my brain was healthy enough to participate in this trial.

Glad your 1B appointment got moved up. The hard part of starting this trial is the waiting. Waiting to get the results, waiting to get the PET (which in the states has become a sticking point in this trial) and then finally getting the clearance.

It will be interesting to see if the Canadian process is any different from here.

PS Your adoptive mom being from Chicago is interesting. I was born and raised there. Stayed there until I was in my 30's, then moved to NY state, Los Angeles area and now here in Georgia. I still think that Chicago has the best museums, art, history and zoos, etc. Lived for awhile in the Lincoln Park area and could take the L anywhere I wanted to go.

Let us know how your 1B appointment goes. Remember this is a journey!

Take Care!

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

Post by NF52 »

squirrel320 wrote: Mon Oct 16, 2023 1:11 pm Thank you Nancy - your reply could honestly not have been more timely. Quite fortuitously, I just received a call that a 1B screening appointment opened up with a last minute cancellation - so from positive 1A result on Friday the 13th :lol: , to 1B screening this Thursday on the 19th! Thank you again - here is to hoping I pass 1B.....I guess or at least that I don't have to wait too long to know where I stand. It will be an early morning across the city to avoid the crush of traffic.
Sheri
Hi Sheri,

Thank you for your kind replies. Leave it to our Canadian neighbors (literally true for most of my life on the other side of Lake Ontario) to have their act together for fast scheduling!! By the time you read this, I hope you have been able to relax a bit after a LONG day!! Trust me, no other days are quite that long or grueling.

[The first day of infusion is a bit boring, since they have you wait for 4 hours to be sure you don't have an infusion (allergic) reaction. After that, it's 30 minutes each time.]

You may have noticed that most of the tests are done with an iPad or recorded, so that the study organizers can ensure a high lever of inter-rate reliability and validity of assessments. The Study Coordinator may have alerted you also that it could take a few weeks to get approval for the next step of imaging with an MRI, amyloid PET and tau PET. That's because the AHEAD-3 (for intermediate amyloid) and AHEAD-45 (for elevated amyloid) studies are in 75 locations in the U.S. and Canada, but you, Chicago Girl and I are all under the auspices of a central monitoring and safety process at the ACTC Alzheimer's Clinical Trial Consortium, funded by the U.S. National Institutes of Health/National Institute on Aging with the stated goal :
To provide an optimal infrastructure, utilizing centralized resources and shared expertise, to accelerate the development of effective interventions for Alzheimer’s disease and related disorders.
I've been a member of the ACTC Research Participant Advisory Board since early 2020, joined by diverse and amazing people who are either in clinical trials for Alzheimer's, have been in observational studies following people at-risk or living with AD, or have been care partners for those in trials. It allows me to get to share the collective voices of people like you, and work with others to improve the experience for all who are thinking about or participating in a prevention or treatment for AD and related dementias, or the study partner of someone in a trial.
I hope you felt valued today, and encouraged and reassured that this really is not a race against others or some perfect version of yourself--it's just what happens when lots of people try to figure out which assessments will best measure all the diverse ways we use our brains on the novel path we're taking through life!

Enjoy a few weeks of wonderful fall weather, I hope, in beautiful Canada. You've earned it!

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

Post by Chicagogirl »

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Yesterday I listened to a webinar on the APT Webstudy. You can see information about this study at:

viewtopic.php?t=8621

It mentions using Quest for some preliminary blood work at various locations. This would be through the ALZ Match program that is being set up.

I imagine it is just the APOE blood work as the AHEAD study uses the PRECIVITY blood test (which is more accurate than the Quest test) to determine the amount of amyloid in the your blood.

By using the Quest test for the APOE gene determination, it would quickly eliminate those who would be ineligible for the clinical trial. If approved through the ALZ Match program (which would be available to you by participating in the APT Webstudy) you may be referred to a clinical trial.

The APT Webstudy allows you to track your memory even if you don't participate in a clinical trial.

Attached is a flyer from the APT Webstudy Winter 2023 Newsletter that has information about the AHEAD Study (at the bottom of the flyer).
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by Chicagogirl »

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Visit 19 - Week 26 - (14th infusion)

My infusions have been going well. I do wonder what happens if the one nurse at the Center, who is able to stick me easily isn’t there. I will continue to go to the Center to get my infusion for the visits that require the memory tests and health screenings.

Also, for the days when I need an MRI before the next visit. When I need the MRI, I have the infusion in the morning at the Center and the MRI in the afternoon at the Research Center.

My Home Infusions hit a slight snag. It took longer to get the Nurse from the Home Health Infusion Center through the training and certification through the Study Sponsor. My understanding is that they have been certified now.

Visit 20 - Week 28 - (15th infusion) will be at the Center this coming week.

This visit is scheduled 3 weeks after my last visit. This is due to my scheduled vacation and available openings at the Center. The Center has gotten busier, with a number of new AHEAD participants and other trials they are doing.

Visit 21 - Week 30

This will be my first Home Infusion appointment.

Eight days of vacation was relaxing. Being in this study with the infusions every 2 weeks and the MRI’s every 6 weeks becomes a little hectic. I also try to swim 3-4 days a week and take an exercise class twice a week. Add that to the normal day to day events, I started feeling stressed.

I continue to do this study because I believe (and hope) that it will offer options to those of us in this situation. If it doesn’t directly benefit me, I see where studies like this are already changing the direction of Alzheimer’s care and prevention.

Hope you all have a great Thanksgiving!

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!
;) 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 20 - Week 28 - (15th infusion)

Visit 21 - Week 30 - (16th infusion)


Both of these infusions went well. The nurse for these 2 visits found a vein quickly, but in my hand. Although this is a little uncomfortable, I am happy it went so well.

Visit 21 was supposed to be my first home infusion, but as in everything these days, paperwork and approvals delayed it. It will now start next week. Since the nurse's schedule and mine didn't mesh as well for next week, she will be coming at 3pm in the afternoon. After that we should be able to settle on the same day every 2 weeks. Can't wait (although it is a long time away) until I only have to do this once every 4 weeks.

Visit 22 - Week 32 will be my first home visit.

Visit 23 - Week 34 will be back at the center as I also need to do a scheduled MRI then.

Hope everyone had a great Thanksgiving, although I understand that Canada celebrated Thanksgiving on October 9th.

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