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

[Chicagogirl]

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Visit 22 - Week 32 - (17th infusion)

This visit was my first HOME infusion visit. Home infusion can only occur after Week 16. Have to admit, I was slightly nervous about doing this at home.

My study site contracts with an International firm that manages the credentials of the home infusion nurses, electronic interaction with the center and setting standards for the nurses to follow. Founded in 2006, they are a Clinical Trial Support Organization focused on clinical trial delivery. Their focus is supporting clinical research delivery, by helping patients participate in trials while remaining in their communities. The costs for this are paid for by the Study Sponsor.

The nurse arrived 15 minutes before my infusion time. She brought her equipment with her. I had cleared off the island in the kitchen for her to spread out what she needed. This included an infusion pump and stand.

The delivery van arrived 5 minutes before my infusion time. This came from the pharmacy at my study site in a refrigerated container. The study drug can only be unrefrigerated for a certain amount of time. The nurse received a text from the van driver and she went out to sign for the drug/placebo. The way the home infusion is set up is that the participant (me) will never have to interact with the van driver. They make a point that the driver will never enter the home. The driver provided the nurse with the saline bag with the study drug/placebo, a smaller saline bag (to flush all the original bag contents into my system) and all the lines and other equipment that the center site would have laid out for my visit.

The nurse took my blood pressure, temperature and blood oxygen. She inserted the line into my arm in my kitchen and then I moved into the living room. The nurse moved with me and watched the pump while filling out her paperwork. The infusion was completed and in 2 hours (including the required 30-minute observation time). She packed up and took all the used supplies with her, after taking my blood pressure and all the vital stats again.

I should state that I don't know if home infusion is available at all clinical trial sites or if all study sites use the same Home Infusion Support Group.

The credentials required to be a home infusion nurse are as follows:

Registered Nurses with at least two years’ experience who can demonstrate the following:

• Experience as a Research Nurse is highly desirable
• Experience in administration of intravenous therapies (Mandatory)
• Cannulation and phlebotomy skills (Mandatory)
• Experience in using Central Venous access Devices (Mandatory)
• Knowledge of providing nursing in the community/home environment would be an advantage
• Enthusiastic, positive attitude with great attention to detail.
• Great organizational skills and ability to plan visit activities independently.
• Excellent communication skills and the ability to complete complex data requirements.

My nurse went through training required by the AHEAD STUDY. Protocols, minimum and maximum time between each infusion and procedures. The nurse assigned to me is an ER nurse at one of the local hospitals. (Her hospital is not involved with this study). She works at the hospital 3 days a week (12 hours each day), so she decided to get involved with infusions at home and is interested in clinical research.

The experience was very pleasant and eliminated an hour drive (during rush hour into the city) to the study site and then back home.

Visit 23 - Week 34 (18th infusion) will be back at the center as I need to do a scheduled MRI #5 then.

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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First of all......

Happy Hanukkah, Merry Christmas, Happy Kwanzaa and all the other Holidays that are celebrated this time of the year! Lets hope that 2024 be the best year for all of us.

Visit 23 - Week 34 - (18th infusion)

Visit 23 - MRI

This visit was back at the infusion center as I needed to have an MRI before Visit 24. Going forward I would probably have the Home Infusion and then go the next day to get the MRI. It gets difficult to schedule these appointments around the Holidays as the MRI center is closed for a period of time and if I didn't do it last Friday, the MRI would have had to been scheduled the first week of January. This would have thrown my infusion schedule into chaos. If you miss some infusions, you need to make them up by going every week for a while to catch up. There is an exception to this if you are ill. They don't want you to have to do too many infusions back-to-back. The Study Doctor can then ask for an exception.

I was the only person at the infusion center that Friday so only 2 nurses. Played Christmas Music on my tablet (without my earbuds).

Infusion went fine and I was out in less than 2 hours. So Good Cheer! Then headed to the MRI center affliated with my study site. In and out of the MRI in an hour and then headed home.

Visit 24 - Week 36 (19th infusion) will still be at the center along with the Memory Tests.

This visit includes the scheduled memory tests, blood work, neurological workup. This will be after the first of the New Year. I should also receive the results of my MRI then. After that I will be back on Home Infusions.

So, my journey continues........

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

Till next Year! Take care!

[Chicagogirl]

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Visit 24 - Week 36 (19th infusion)

Along with Memory & Thinking Tests, there are Physical & Neurological Exam, ECG, Blood Work & Depression & Well Being Questionnaires.

This was all done at my central site. When my visit includes memory tests, blood draws, etc. I go the main site. I also have the infusion done there.

Received the results of MRI #5 that was done before Visit 24. I have had NO Aria or microbleeds found on any of the 5 MRIs and no significant findings on any of the 5 MRIs that I have had.

My infusions have been going well.

When I am at the Center, the nurse tends to insert the infusion line into the snuff box area of my hand (Had to look it up: The anatomical snuff box is a triangular deepening on the radial, dorsal aspect of the hand). This is an area between my thumb and pointer finger. They seem to find my vein there easier. Although it doesn’t really hurt it is slightly uncomfortable. They wrap my hand well so the line doesn’t come out and I have to keep my arm straight for about one and a half hours for the infusion and the flush afterwards.

I always dread the memory tests. The hardest part for me is the one where a grocery list repeated to me 3 times. After each one, I am asked to say as many items as I can. I get better by the 3rd time, but still can’t remember everything. Then later in the tests, they ask you what of the list you remember, after you have been distracted by everything else.

I was diagnosed with CAPD (Central Auditory Processing Disorder) over 20 years ago. Probably had it my whole life. Now there are therapies they do with children and teens to correct it. CAPD refers to deficits in the neural processing of auditory information. Your ears hear it, but not all of it gets transferred to the brain. The therapist that tested me said I must have figured out coping skills to have succeeded in the business world like I did. For me what it means is that I am a visual learner and have issues with auditory learning. Probably why I dislike the memory tests.

Visit 25 - Week 38 will be back on home infusions.

This will continue every 2 weeks until Visit 30 – Week 48 where I will go back to the Center and have all the testing that was done at Visit 24 – Week 36. There will be another MRI done before Visit 30.

HOPE EVERYONE HAD A GREAT NEW YEAR! And that 2024 is better for all of us!

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!

[NF52]

...I always dread the memory tests. The hardest part for me is the one where a grocery list repeated to me 3 times. After each one, I am asked to say as many items as I can. I get better by the 3rd time, but still can’t remember everything. Then later in the tests, they ask you what of the list you remember, after you have been distracted by everything else.

I was diagnosed with CAPD (Central Auditory Processing Disorder) over 20 years ago. Probably had it my whole life. Now there are therapies they do with children and teens to correct it. CAPD refers to deficits in the neural processing of auditory information. Your ears hear it, but not all of it gets transferred to the brain. The therapist that tested me said I must have figured out coping skills to have succeeded in the business world like I did. For me what it means is that I am a visual learner and have issues with auditory learning. Probably why I dislike the memory tests....

Till next time! Take care![/b]

FWIW, my husband, who has an encyclopedic memory of music, movies, books, and can listen to a short piece of music and tell you what it's from, and which version of it with which conductor he likes, needs a written grocery list every time! My neuropsychologist, who seems very smart, shared that she also needs a written list, every time.

I've known students diagnosed with central auditory processing disorder, which was little recognized until about 20 years ago. Teachers are confounded by it, because students have good reading and writing skills, good vocabulary, strong problem solving. Then the teacher says something like: "Go to the back table and find your folder, then take it to your desk and start the assignment labeled Suffragettes. When you finish with that you can do free reading."

The teacher thinks the student is misbehaving when he gets the folder, comes back to his desk and starts his free reading book. But she put too much info out at once!

People who find this hard to understand can get a taste of it when you say:

"Think of a time when you were in a noisy restaurant or crowded train, or had a bad cold. Now try to imagine hearing a list of 12 items and repeating them back in 30 minutes."

The accommodation is what you've learned: quiet, distraction-free setting, visual input and repetition. Since you know you have CAPD, think of it as if you had color-blindness but were asked to pick out differences in Sherwin-Williams shades of white--just a temporary, irrelevant test!

[Nevada]

I am now in week 121 of the Ahead study and receiving monthly infusions. Since I have passed the halfway point, I received the second Amyloid-beta and Tau PET scans and received my 9th MRI for this study. I asked the MRI technician if the MRI protocol had changed because it felt like it took much longer this last time, but she said it was the same length of time. I have had no apparent side effects other than one microhemorrhage at the beginning of the study (which leads me to think that I am probably receiving a placebo). I don’t sense any effects from the infusions. I believe that my cognitive status is fairly stable except for perhaps slightly increased difficulty remembering names. Thursday’s visit was a 14 hour day with 6 hours of travel by a study-paid Lyft ride, infusion, weight, blood draw, ECG, cognitive testing, and physical examination by a neurologist. This resulted in missing my neighborhood poker game that evening, but I have no issues making this “sacrifice” because I continue to believe this is an important study (and I probably saved a few bucks by not playing). With more data, we will learn what people can benefit most from Leqembi and at what point is it most effective for persons with pre-clinical dementia. I am excited that research is revealing more about different subtypes of Alzheimer’s dementia that I believe will eventually lead to greater specificity and individualized treatment. I commend all of you who are considering or are participating in clinical trials because I believe that we will help advance the science and that my children (who have one APOE4 allele since I have two) and my grandchildren will benefit.

[Chicagogirl]

I am now in week 121 of the Ahead study and receiving monthly infusions. Since I have passed the halfway point, I received the second Amyloid-beta and Tau PET scans and received my 9th MRI for this study. I asked the MRI technician if the MRI protocol had changed because it felt like it took much longer this last time, but she said it was the same length of time. I have had no apparent side effects other than one microhemorrhage at the beginning of the study (which leads me to think that I am probably receiving a placebo). I don’t sense any effects from the infusions. I believe that my cognitive status is fairly stable except for perhaps slightly increased difficulty remembering names. Thursday’s visit was a 14 hour day with 6 hours of travel by a study-paid Lyft ride, infusion, weight, blood draw, ECG, cognitive testing, and physical examination by a neurologist. This resulted in missing my neighborhood poker game that evening, but I have no issues making this “sacrifice” because I continue to believe this is an important study (and I probably saved a few bucks by not playing).

Nevada.....

So glad to hear from you! Wondered how your journey was going. Congratulations on getting to week 121 of your journey. That is a great accomplishment, especially if you think you might be on the placebo. I didn't know that the study would pay for a Lyft ride to get you to the study center. I'm sure that makes it easier for you. Your humor about missing your poker game is great (lol)!

With more data, we will learn what people can benefit most from Leqembi and at what point is it most effective for persons with pre-clinical dementia. I am excited that research is revealing more about different subtypes of Alzheimer’s dementia that I believe will eventually lead to greater specificity and individualized treatment. I commend all of you who are considering or are participating in clinical trials because I believe that we will help advance the science and that my children (who have one APOE4 allele since I have two) and my grandchildren will benefit.

You put it so eloquently about the science of treatment and the great gains that have been made. Hopefully participation in this trial will generate tons of information about addressing pre-clinical Alzheimer's as my daughter has one APOE4 allele also.

Thanks for your update!

[Chicagogirl]

I've known students diagnosed with central auditory processing disorder, which was little recognized until about 20 years ago. Teachers are confounded by it, because students have good reading and writing skills, good vocabulary, strong problem solving. Then the teacher says something like: "Go to the back table and find your folder, then take it to your desk and start the assignment labeled Suffragettes. When you finish with that you can do free reading."

The teacher thinks the student is misbehaving when he gets the folder, comes back to his desk and starts his free reading book. But she put too much info out at once!

People who find this hard to understand can get a taste of it when you say:

"Think of a time when you were in a noisy restaurant or crowded train, or had a bad cold. Now try to imagine hearing a list of 12 items and repeating them back in 30 minutes."

The accommodation is what you've learned: quiet, distraction-free setting, visual input and repetition. Since you know you have CAPD, think of it as if you had color-blindness but were asked to pick out differences in Sherwin-Williams shades of white--just a temporary, irrelevant test!

NF52
Love your explanation of CAPD. I use it now whenever I need to explain it to someone. Thanks!

[Chicagogirl]

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Visit 25 - Week 38 (20th infusion)

Visit 26 - Week 40 (21st infusion)

Both of these infusions were done by my Home Health nurse.

This has become such a simple process by agreeing to the home health process. It is so much more relaxing, and I am grateful that my site offers this as an option. My Home Health nurse has 3 dogs so my 8-year-old terrier will join us after the infusion line is inserted and I am sitting on my couch. She will be next to me with her head in my lap (unless she is out on a 3 hour walk with my husband). If your site offers this option, I would urge you to consider it. And no, they don't provide emotional support dogs.

There are two more home visits, then the next one with the home visit infusion in the morning and then I will head off to the site for the 6th required MRI in the afternoon.

Last fall, I inquired about the possibility of donating my Brain to the research center. I was told that there was a study being developed to accomplish this. Since I was in a clinical study already, I would not have to go through all the scans and testing they normally require.

I've been told that this will be starting soon.......
So, stay tuned for further information as I get it.

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!

[Nevada]

I am in week 124 of the Ahead 3 study and just received and signed a revised Informed consent form yesterday for the study which includes two new provisions. The first is the option of a 2 year open label extension (treatment with Lecanemab) if you complete the study. The second is a 2 year open label extension if you show a cognitive decline during the course of the study. I suspect that this second provision was included to bolster enrollment and retention particularly for those who believe that they are receiving a placebo. This will also potentially provide additional useful data to the study investigators. The wording on my consent form is as follows:
“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.”

I know that this has been in the works for a while, but it has taken additional time for revisions to be incorporated and then approved by the local Institutional Review Boards. I am glad to see that it is now "official" at my center.

[NF52]

I am in week 124 of the Ahead 3 study and just received and signed a revised Informed consent form yesterday for the study which includes two new provisions. The first is the option of a 2 year open label extension (treatment with Lecanemab) if you complete the study. The second is a 2 year open label extension if you show a cognitive decline during the course of the study....
I know that this has been in the works for a while, but it has taken additional time for revisions to be incorporated and then approved by the local Institutional Review Boards. I am glad to see that it is now "official" at my center.

Nevada,

Many thanks for sharing this important development. You are 12 weeks "ahead" of me in AHEAD, since I had my Week 112 visit this past week, although I have had more infusions, since I am at 51 infusions. Each of the 75 AHEAD study sites in the US and Canada uses either the NIH-required Institutional Review Board-approved consent developed by the Alzheimer's Clinical Trial Consortium, or its own slightly modified for local conditions IRB approval.
It's a sign of how clinical trials have changed over just the last three years to be VERY different than failed trials of the last decade. The AHEAD study is adapting to participant needs and the latest science while maintaining the gold-standard of a "blinded" trial in which the study site staff, central site staff and clinical trial participants are unaware of whether the assignment is to the 50% placebo "arm" or the 50% treatment "arm" of lecanemab until the last person in the trial finishes THEIR 4 years and the study is able to release data.

This new option of switching to open-label treatment with infusion of lecanemab and the plan for an open-label extension for all participants at the end of their 4 years is not the only participant-centered change by AHEAD organizers at ACTC. ACTC, funded by the NIH, is the central organizer and monitor for AHEAD, and for ALL ACTC-approved clinical trials. The drug companies, like the study sites, are partners with ACTC--not the boss. Here's a list of how the AHEAD trial has adapted (and improved in my opinion) based on participant feedback and availability of new tests:

• Potential participants no longer have a tiring 4-5 hour day for their first visit, covering screening consent forms, physical, EKG, blood and urine tests, neuropsychological testing, medical history, and study partner interview and questionnaire.
  • Potential participants and their study partners now have a first visit of just 1-2 hours, with extensive time for discussion of the consent form and the trial requirements, which Chicagogirl described here: Visit 1A

• Potential participants are no longer automatically sent for an amyloid PET scan, which takes about 2 hours in total and involves an IV infusion. It can cause people significant worry during the 2-3 week wait for the PET results.
  • PrecivityAD is now used as a simple blood test with about 90% accuracy in predicting whether or not someone will have a positive amyloid PET scan. Those who are clearly "negative" can be learn within 2-3 weeks of their first visit that they are unlikely to have even "intermediate" levels of amyloid plaques. At my relatively small site, over 200 people have been screened, with about 90% receiving the news that they don't qualify based on their amyloid blood test or other inclusion or exclusion criteria after a careful assessment and a few hours of time. Like Tiramisu1984 and others who have posted on this thread, they come away with more information than they had before screening: they have normal cognition and no signs of "positive" Alzheimer's biomarkers..
    • Sites are now adding another sub-study: to invite back those whose PET scan for Precivity AD test was below the "intermediate" level for annual cognitive testing and repeated blood tests. This allows the data, which will be anonymized, like all other AHEAD data, to be studied to learn more about factors that either protect or predict an increase in amyloid or a change in cognition. These people also will get an annual report of their continued status. At my site, six people have already signed up to come for their annual re-check.
  • AHEAD added home infusions as an option for people in some trial sites. The goal is to reduce travel time and the burden of coming to a central site, after about 4 months of on-site infusions, when adverse events are most likely to happen .
    • Chicagogirl uses this option and describes the rigorous requirements for the nurses who do this here: Visit 22 - Week 32 - (17th infusion)
  • AHEAD added use of Uber or Lyft for people who live at a distance from the study site, or who may not have access to transportation,.
    • You and others have been able to participate at sites several hours from your homes, in line with the NIH priority to expand participants who may live in rural or under-served areas or lack transportation .
  • Sites have increased options for people who may still be working to have infusions on certain days or times.
    • My own Study Coordinator comes in at 6:45 AM twice a month to enable someone to have an infusion before work.
  • As you noted, people who have completed at least two years on the trial (and who will have then taken another Amyloid PET, Tau PET and several MRIs), whose memory scores have changed from "no impairment" to "mild cognitive impairment" will be told that information, because it is felt to be ethically necessary to share that. Participants in many clinical trials have consistently said they they value transparency and WANT to know if their cognition changes significantly.
    • They will be offered the option to change to the Open-Label sub-trial of AHEAD, in which they will still come for all the same cognitive tests, physicals, careful monitoring in initial doses of lecanemab with MRIs, for the remainder of their 4-year trial, after which they would be eligible for the "regular" Open-Label Extension.
      • Having them followed by experienced clinicians who know them well ensures that they have high-quality access to safety monitoring. It also allows more needed results to see at this very early stage of MCI if treatment is safe and effective for them. No one who chooses not to be in the Open-Label study will be removed from the trial.
    • The AHEAD organizers are continuing enrollment, including in under-served communities (economically, geographically, racially and ethnically) to ensure that their final data will be sufficient to demonstrate to what extent and for whom lecanemab is safe, effective in removing amyloid plaques and preventing their formation, and clinically effective in maintaining normal cognition in people with intermediate or elevated amyloid, who in other studies often progressed to MCI within 4-7 years after reaching "elevated" range.
    • My site and others are working on a sub-cutaneous auto-injector that may be available late this year, which would help those who find IVs difficult, reduce the cost of treatment and allow participants to use these at home once they had been in the trial for a period of time.
    Nancy