.Chicagogirl wrote: ↑Wed Feb 22, 2023 8:47 am...If I have the required Amyloid, my hope is that my brain is healthy enough to go forward with this study. Based on reading all the posting on this drug including the adverse effects and talking to my physicians, I will sign the Informed Consent at VISIT 3
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This information is based on my understanding of how the trial works. I am a participant, not a medical expert. You should question your Study Coordinator if you apply to be considered for participation in the trial to verify and then review the literature on adverse events with your physician.
Best wishes to all have been following this thread and thanks to those who are participating in this trial. You are all warriors in this quest. I will post more when I know more about my status. Until then.... Remain optimistic!
Time for full disclosure: I too am in the AHEAD-45 trial, and yesterday received my 32nd infusion of what I believe is lecanemab and not a placebo. More on that in a bit. Chicagogirl and Nevada have known I am in this trial and have respected my decision not to share my participation up to this point. Deep thanks to them both! I hope they will let me intrude just this once on Chicago Girl's forum to share my own experience with lecanemab.Nevada wrote: Chicagogirl: Great description of your screening for the AHEAD study. I am 2 years into the Ahead-3 arm of the study (visit 24)...
What motivates me to participate is my hope that Lecanemab/Leqembi will be a useful part of treatment for people with beta amyloid risk factors or early signs of dementia. I also feel well cared for by the study staff. I believe that early intervention and additional treatments perhaps in combination will be a key to finding an eventual cure.
My reason for sharing this now is simple: It's time to demystify participation in clinical trials, especially for those of us who are fortunate to be cognitively healthy while at significantly higher than average risk based on ApoE4 and/or family history. And frankly, if it's okay for someone to share that they have pre-diabetes without having diabetes, or pre-cancerous colon polyps without having colon cancer, or coronary artery disease without a heart attack, it's time to be able to say "I have Preclinical Alzheimer's disease"--a disease that develops for up to 20 years before what we have been conditioned to think of as a specific diagnosis of an already obvious disease called "Alzheimer's" .
Note: Feel free to decide "TL/DR" (too long; didn't read) to the rest of this!
I have both ApoE 4/4 and Preclinical Alzheimer's disease, which I have had since at least 2017, at age 65, although I didn't know it until 2021, two years after the Generations trial ended. If hearing ApoE 4/4 is scary, "Preclinical Alzheimer's disease" is scary on steroids. That why we need to begin to say out loud, without apology: "You can have these disease biomarkers in spite of having done almost everything to prevent them. You still have a fully functioning brain and find joy, purpose and normal, everyday frustrations in your life. And you can decide to act, or not act, on this knowledge with MANY choices"
Blood tests for amyloid are here, and tau blood tests are in clinical trials. MANY people will at some point learn this about themselves--we have to start talking about it now. Preclinical Alzheimer's disease means someone has biomarkers of amyloid beta and/or phosphorylated tau (aka ptau 181 or tau 217) on either blood tests, PET scans or a spinal tap. Since 2005, the ADNI Trials [Alzheimer's Disease Neuroimaging Initiative] has benefited from thousands of volunteers at risk of AD, who agreed to have multiple imaging studies of their brains over time, without knowing the results of those tests and without taking any clinical trial drug. Data also comes from studies of mice with ApoE4 and other risk genes and drug trials in the last decade or so. Amyloid beta plaques (the gravestones of misfolded amyloid beta oligomers) and tau are strongly associated with, but not a certainty for a future diagnosis of Alzheimer's dementia--not vascular dementia, Lewy Body dementia, fronto-temporal dementia, or Parkinson's-related dementia. They are the NOT only road to AD by any means--but for some of us they are like the local interstate-- a fast way to new and unknown destinations.
As with all those other "pre-X" diseases, I have no way of knowing if I have a "use by" date coming up in the next 5 or 20 years. But my risk curve started rising steeply starting about age 65. [7 of the 10 siblings in my mother's family, and all of the 5 sisters, died of Alzheimer's and vascular dementia that started in their early to late 70's; my dad died at age 67 of cardiac arrest after a quadruple bypass.]
I spent many, many hours reading published research, watching presentations by those affiliated and non-affiliated with anti-amyloid research, both pro and con. I take the safety issues as seriously as anyone can take it--because I elected to join the study, putting myself potentially at risk and impacting my husband and family. I have personally discouraged two people with ApoE 4/4 from beginning screening for this trial; one due to severe claustrophobia in an MRI machine, which is required multiple times; the second due to known multiple microhemorrhages and CAA disease, which would almost certainly be disqualifying due to the published results from lecanemab's PHASE 2, CLARITY (CORE) and CLARITY's Open-Label Extension. However, I have seen no reports of deaths in AHEAD in people who all have normal cognition. That MAY mean that further inflammation and damage to blood vessels happens during MCI/mild AD which increases CAA and risk of macrohemorrhage. The final results of AHEAD will not come out until the last-to-join participant finishes their 4 years, probably in 2027 or early 2028.
So here's what being in this trial, and I suspect on lecanemab, has been like for me:
- After having my weight, BP and temp taken, and my recent medical changes if any updated, my NP Coordinator approves the on-site pharmacist to start making my bespoke dosage of 10mg/kg of weight of either a placebo or lecanemab. No one at the study site knows what I am getting, nor does anyone reading my MRI or PET scan. I am simply getting a number on an IV bag of mostly saline. I settle in for about a 40-45 minute wait, depending on how many other people may also be in line for infusions for this or other trials in other private rooms. The Research Clinic is quiet, unlike any hospital I have ever seen. I joke that it's my spa treatment to sit in a comfy chair, read a great book on my Kindle while drinking coffee or water, listening to a Sirius XM channel of my choice piped in (iPads with Amazon Prime are also available), and have staff who see me every two weeks stop by to share stories of their kindergartner falling asleep on a 10-minute ride home, or their 92 year old dad who loves the family stew recipe, or my own grandkids' latest adventures.
- I have veins that nurses love, so infusions are a quick jab and an attachment to a long cord that goes to a typical IV stand with the infusion bag that drips slowly into either my left or right arm--usually rotating biweekly. After 60 minutes, the bag beeps, the same nurse returns and adds a quick saline flush for 5 minutes, then removes the needle, puts on a tiny gauze pad and those colorful bandages that wrap around your arm. I read for another 25 minutes, to be sure I haven't had any immediate serious reactions, before they again take my BP, pulse, and temp. Then I head out for an easy hour drive back home. The whole process takes from about 8:50 AM when I leave my driveway to about 1:30 PM when I arrive home.
- I had "symptoms", or side effects after some of the infusions in the first 7 months without ever feeling like I would have needed to take a day off from doing what I had planned. My symptoms were some of several known side effects, not "adverse events" of lecanemab, in that same way that nausea can be a side effect of antibiotics or feeling wired can be a side effect of prednisone. My side effects have included mild headaches combined sometimes with fatigue that calls out for a nap of an hour or so, and mild nausea and/or abdominal cramps-about what you might get after eating something that you knew you shouldn't. This always happened about an hour or two after waking up, so never interfered with going out later, with the exception of a day early on when I slept for 90 minutes in both morning and afternoon then felt fine.
- There were also some nights early on with the opposite effect: being wide awake with lists of names, facts or the need to do the NYT crossword puzzle. Not insomnia, more a feeling that my brain seemed to be re-accessing old files. (I now really enjoy the test that starts: "Name words that start with letter ___"!)
- I also had mild vertigo that was intermittent, never all day/every day. More the sensation of being "still on the boat" I would take one meclizine (the "old" Dramamine) and be fine. Several MRIs during those 6 months showed NO edema, and I was told that the this is a common symptom of lecanemab, but NOT a sign of edema or brain bleeds.
- At about the 7 month mark, I had a longer episode of about 8 days of intermittent, mild vertigo and mild headache, with no other issues and notified the study site. They promptly cancelled my next infusion and scheduled me for an MRI. That MRI showed one "probable" spot of ARIA-H (Amyloid-Related Imaging Abnormality:micro-hemorrhage) that was less than <5 mm, or slightly less than the diameter of a regular pencil eraser and a dot on an MRI. It was not a stroke and I had no visual, motor, or language effects, nor did my ability to do anything changed. A week or so later I was walking 5 miles on the beach in Maine easily. In the CLARITY trial of people with MCI/mild AD, "isolated ARIA-H", without ARIA- E (edema) was seen in 7.8% of placebo participants and 8.9% of lecanemab participants. In other words, Nevada and I had an almost equal chance of having had a microbleed on either the placebo or on lecanemab.
I missed one dose, which the Study Site Doctor told the main site would NOT be made up, and have been fine since. Now 14 months in, I have had several more MRIs, all with no signs of ARIA-E or additional microbleeds.
- I do BETTER now that I did 15 months ago on several tests of "immediate, cued and delayed recall."
Here's one example: Listen to someone read a list of 12 common grocery store items and then repeat as many as you can in any order. Now the list is repeated; again repeat as many as you can. Repeat two more times. Now remember those words for 20 minutes while your mind is busy on an Ipad task in which you are shown photos of a few dozen people with a name provided for a few seconds. Then you are asked to pick them from photos of people who look similar to them, and then to pick which of three names was theirs, with a first letter cue, if needed. Now repeat the grocery list. That's a test of your hippocampus--and if mine is shrinking from lecanemab, mine appears to have learned how to do more with less.
- At the end of the calendar year, I got paid $50 for each clinic visit since starting the actual trial, not a huge amount for 5 hours biweekly, or 6 hrs when I have testing, or the MRI or PET scans--also an hour each way. And that money is also taxable, so I on net I get about $ 40. or 8 bucks an hour--not the reason anyone signs up for a clinical trial.
- At "Week 62/ Visit 37" in AHEAD-speak, I have had a few more infusions more than "Nevada", who is on a monthly schedule with "intermediate amyloid" in AHEAD-3 (defined as 20-<40 centiloids on a PET scan). I am on a biweekly schedule until October 2023, when I too will move to a monthly schedule. My schedule is required to get the elevated (> 40 centiloids) level of amyloid plaques and associated toxic amyloid oligomers removed completely and to reduce both toxic tau and the recently identified toxic "neurofilament light" protein that wreaks havoc in neurons (it's written as Nfl--not NFL football!)
- My monthly infusions will finish about November 2025. The decision to have a 4-year trial for those of us with normal cognition, versus the 18-month CLARITY trial of lecanemab for those with MCI/mild AD, is due to the different time frames for progression. People can stay at what is called "A+/CN" [Amyloid positive/cognitively normal] for years. Those with a diagnosis usually show slow but measurable change in MCI/mild AD over 18 months.
I have, and always will, respect our absolute right, whether as individuals with normal cognition and risk of AD or as individuals living with cognitive impairments, to follow our values, beliefs and joy. This forum is a wonderful place to put that into action for each of us!
Nancy