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

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

Post by Chicagogirl »

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Last edited by Chicagogirl on Sun Mar 26, 2023 7:49 am, edited 1 time in total.
;) 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)

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Last edited by Chicagogirl on Thu Apr 06, 2023 9:15 am, edited 1 time in total.
;) 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 »

Documenting my journey (finally my site is up and running again) in the AHEAD 3-45 CLINICAL TRIAL......

VISIT 2 - 2-3 hours long. (There is a visit 3, 4 and 5 visit before acceptance into the study).

This is the Amyloid PET scan to measure the amount of Amyloid build-up in your brain using a tracer called NAV4694. The PET scan is a brain imaging test. The original work up at VISIT 1 showed Amyloid in the blood. This scan is to determine the amount of Amyloid.

A very small amout of the radiotracer was injected into a vein in my arm. (I'm a hard stick, but this was easy). I then had to rest for approximately 50 minutes while the tracer made it to my brain. No activity is allowed during this period. This means no reading, talking, checking phone or listening to music. I would suggest you bring a wrap or sweater as it is usually cold in the radiology area. You then remain in the scanner for up to 30 minutes. This scan is very quiet, and I came close to falling asleep.

After the radiologist / study doctor reviews the scan it is sent to the Mayo Clinic where it is reviewed again. This ensures that all participants in the study are reviewed in the same way. Then you will proceed to VISIT 3 to learn the level of Amyloid in your brain and if you qualify.

Only individuals with intermediate or elevated Amyloid levels will quality to participate in one of the two arms of this trial: AHEAD 3 or AHEAD 45.

The AHEAD 3 Trial is for intermediate levels of Amyloid in the brain. This group will come once very 4 weeks for the infusion. You will receive the actual drug or a placebo.

The AHEAD 45 Trial is for elevated levels of Amyloid in the brain. This group will come once every 2 weeks for the infusion. You will receive the actual drug or a placebo.

Depending on the results of the Amyloid Pet Scan, the following visits are required to determine if you are eligible for the study.

THE NEXT VISITS ARE:

VISIT 3 - (1-2 hours) RESULTS & CONSENT. Participant receives the result of the Amyloid PET scan and the APOE genetic test and counseling regarding your status. (Already know I am e4/e4) This visit also includes: Signing the informed consent, review of medical history, memory, thinking skill tests and blood tests.

VISIT 4 - (2-3 hours) MRI SCAN. This scan reviews images of your brain to make sure it is healthy enough to continue in the study.

VISIT 5 - (2-3 hours) - Tau PET SCAN. This scans your brain to measure the amount of Tau in your brain using a radiotracer called MK-6240. Tau is a second abnormal protein that builds up in the brains of people with Alzheimer's. You will rest for 90 minutes (no activity) before the actual Tau Scan.

If approved for the study, you will then receive infusions based on which arm of the trial you are on. There will also be additional MRI scans during the trial to make sure your brain is still healthy.

Besides the infusions (every 2 weeks or every 4 weeks) there will be 5 additional visits with your Study Partner over the next 4 years with memory tests, etc. Weeks 48, 96, 132, 168 and 216 (or an early termination visit).

For me the optimal result would be that I don't have enough Amyloid in my brain to qualify. BRING OUT THE CHAMPAGNE!

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.

A little about me: I am in my early 70's (e4/e4) and took care of my mom in our home when she developed Alzheimer's. After experiencing that, with the paranoia and delusions, my goal is to assist in finding a cure for this awful disease.

I was formerly in the Generations Study Clinical Trial (CNP-520) in 2017 and hope I am able to contribute to this trial. I agree with all the recommendations regarding eating, exercising, healthy sleeping, overall health monitoring and social needs as a way to delay the onset of dementia. But I also believe that clinical research is important to the quest to conquer this disease. Even if I am found not eligible to continue in this study, I am still contributing to the overall Alzheimer's research just by participating.

I know that when I found out I was e4/e4 in 2017 I felt so isolated and alone. My husband was very supportive, but I was the one with the e4 gene. Reaching out to some participants who identified as being in the Generations Study helped me to cope with the understanding of what this all meant. I will be forever grateful to them. So feel free to PM me if you want.

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!

FOR LOCATIONS participating is this study: https://www.aheadstudy.org/find-location/

Other postings on this forum:

viewtopic.php?t=8303 Lecanamab: Efficacy, Side Effects and More

viewtopic.php?t=8367 Lecanamab Approved!
Last edited by Chicagogirl on Mon Mar 06, 2023 9:30 am, edited 2 times in total.
;) 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 Nevada »

Chicagogirl: Great description of your screening for the AHEAD study. I am 2 years into the Ahead-3 arm of the study (visit 24). I have had one verified microhemorrage, but no other side-effects of which I am aware. Because of the microhemorrage early in the study, my neurologist thinks that I am probably receiving the active medication. I am not as sure since I also had a microhemorrage at baseline so obviously they occur for various reasons other than Lecanemab/leqembi. I find that the most challenging part of the study is the cognitive testing every 3 months and the 149 mile ride to the medical center once per month (or twice when a MRI is scheduled). 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.
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by Julie G »

For me the optimal result would be that I don't have enough Amyloid in my brain to qualify. BRING OUT THE CHAMPAGNE!
You're very brave to quantify. Praying that you DON'T qualify. Thanks for sharing.
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by mrsdoc83 »

Chicagogirl, I'm rooting for you and I hope your next visits go well! Update us as you're able...
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Re: AHEAD 3-45 STUDY CLINICAL TRIAL (LECANEMAB - BAN 2401)

Post by SandyZ »

mrsdoc83 wrote: Thu Feb 23, 2023 9:51 am Chicagogirl, I'm rooting for you and I hope your next visits go well! Update us as you're able...
Hi mrsdoc83,

As a welcome intern, I see that this is your first time posting by offering words of encouragement. Isn't this site great?!?

Have you been following news of the clinical trials on Lecanemab, the drug used in this trial and recently approved by the FDA for people with MCI/mild AD.? Perhaps you'd like to share more of how you came to learn about it.

Also, I'd like to mention the myriad of areas where information can be found.

The Primer is a detailed and informative resource written by a practicing Medical Doctor with ApoE4/4.

In addition, the How to Guide offers tips on how to navigate forums, including how to quote members when you respond to posts so they get an email notification of your post (tip: use the quotation icon in the upper right of any post). The How to Guide also demonstrates how to use the Search function for topics and how to subscribe to topics of interest in the forums.

The Wiki is another resource full of information that you might helpful.

Finally, if you would like to learn more about other community members' experiences or even continue to share more about your own, feel free to link to Our Stories.

In gratitude,

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

Post by Chicagogirl »

mrsdoc83 wrote: Thu Feb 23, 2023 9:51 am Chicagogirl, I'm rooting for you and I hope your next visits go well! Update us as you're able...
Mrsdoc 83... Thank you for your kind words! I will keep up my updates. Appreciated the comment.
;) 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 »

Julie G wrote: Thu Feb 23, 2023 4:39 am
You're very brave to quantify. Praying that you DON'T qualify. Thanks for sharing.
Thanks Julie for your thoughts and prayers!
;) 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 »

Nevada wrote: Wed Feb 22, 2023 5:12 pm Chicagogirl: Great description of your screening for the AHEAD study. I am 2 years into the Ahead-3 arm of the study (visit 24). I find that the most challenging part of the study is the cognitive testing every 3 months and the 149 mile ride to the medical center once per month (or twice when a MRI is scheduled). 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.
Nevada..... Thank you for posting what motivated you to participate in this study and that you feel cared for by the study staff. I haven't seen very many individuals posting that they are actually in this study. But I have to believe there are more. I think that knowing there are others is comforting to those going through the same thing. Driving 149 miles every 3 months must mean you are dedicated to this quest! I agree that the cognitive testing has been the most challenging part of the study. Keep us updated as you progress.
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
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