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

Alzheimer's, cardiovascular, and other chronic diseases; biomarkers, lifestyle, supplements, drugs, and health care.
J11
Contributor
Contributor
Posts: 3351
Joined: Sat May 17, 2014 4:04 pm

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

Post by J11 »

Julie G, Chicagogirl has given me an eviction notice so I will not take over the thread with my comments.

Nevertheless, the Lecanemab safety issue is still worth a brief rebuttal here and more on the Aducan thread. From what I now understand the recently reported fatality was in the long term extension and not the phase 3. This seems likely as the side effects with most mabs appear to happen typically early on in treatment. 5 months ago all of the on treatment phase 3 patients would have been treated for 15 months. I found this of interest because I wonder to what extent the per protocol phase 3 patients might have been different from the per protocol long term extension patients. Perhaps the exclusions were stricter during the phase 3.
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 »

J11 wrote: Tue Nov 01, 2022 5:54 pm Julie G, Chicagogirl has given me an eviction notice so I will not take over the thread with my comments.
I had suggested that maybe there could be two threads. One for the mechanics on what happens when joining the trial and another for all the scientific and medical detail under a lecanemab thread, not the adum thread. I absolutely respect the information that you provided and the detail that you delve into. I think the knowledge that you have and the way you present it is phenomenal.

Sorry, I did not intend for it to be viewed as an eviction notice.

Chicagogirl
Last edited by Chicagogirl on Mon Mar 06, 2023 7:55 am, edited 1 time in total.
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
J11
Contributor
Contributor
Posts: 3351
Joined: Sat May 17, 2014 4:04 pm

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

Post by J11 »

Chicagogirl, thank you for your reply.

I appreciate your clarification as online it is even more difficult for me to understand theory of mind issues than in day to day life.

This is such a monumental moment for the global AD community; the Lecanemab presentation at CTAD will happen this month! I am so grateful for the efforts that the pharmaceutical companies have made over many decades to move us to where we are now. The products that are in development will offer me a safe and effective means of countering AD pathology when needed at the earliest stages.

It means so much to me knowing that I will not descend into the dementing illness that all previous generations of my family experienced. When I started the Aducan thread I could feel the clock ticking down ... they wanted another 5 year confirmatory trial and then something might not be quite right ... at some point you just run out of road and your cognition declines and there is nothing that can help and it keeps declining. The Clarity results for Lecanemab were not exactly a surprise to me (especially after spending years on the Aducan thread trying to understand how amyloid removal relates to cognition in early AD and then the Clarity trial landed exactly on the regression line), though it is still surprising to arrive in the future and find that it all worked to plan and we got to the ... and everyone lived happily ever after part.

From where we stand now, I am fairly confident that I will not even reach the MCI stage. I might have years to prepare for preventative AD treatment. There is already a tidal wave of dementia drugs approaching and even more are entering clinical trials.
User avatar
Julie G
Mod
Mod
Posts: 9187
Joined: Sat Oct 26, 2013 6:36 pm

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

Post by Julie G »

I had suggested that maybe there could be two threads. One for the mechanics on what happens when joining the trial and another for all the scientific and medical detail under a lecanemab thread, not the adum thread.
This is great idea, Chicagogirl. I'll start a new thread about lecanamab benefits/side effects.
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 for those who are considering this study:

I haven't posted since October 14th when I completed the 1B visit. It seemed to take longer than I expected for the results to be reviewed and approved. (It has only been 1 month, but it seems like a long time to me). I passed the cognitive and medical tests. I am now eligible for Visit 2 which is the Amyloid PET Scan. Unfortunately, this will not occur until January since their PET Scanner is being removed and replaced. It will then need to go through the normal certification before it can be used.

If you have questions about the process or just want to talk about your experience, you can always PM me. Or you can post here so those in the study will feel some comfort knowing there are others in this trial. If you post here, you might get answers from others in the trial also.

OTHER INFORMATION: There is CTAD (Clinical Trials on Alzheimers Disease) Conference on November 29th. They will be reporting on the Phase 3 Lecanemab trial CLARITY. This is a trial for those with MCI or mild Alzheimers.

There will be a number of individuals analyzing this information. Look for it in the following thread set up by Julie G to handle the scientific and medical discussion of LECANAMAB (there are already some posts there):

LECANAMAB: EFFICACY, SIDE EFFECTS, AND MORE

Happy Thanksgiving to everyone!
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
User avatar
Julie G
Mod
Mod
Posts: 9187
Joined: Sat Oct 26, 2013 6:36 pm

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

Post by Julie G »

I haven't posted since October 14th when I completed the 1B visit. It seemed to take longer than I expected for the results to be reviewed and approved. (It has only been 1 month, but it seems like a long time to me). I passed the cognitive and medical tests. I am now eligible for Visit 2 which is the Amyloid PET Scan. Unfortunately, this will not occur until January since their PET Scanner is being removed and replaced. It will then need to go through the normal certification before it can be used.

If you have questions about the process or just want to talk about your experience, you can always PM me. Or you can post here so those in the study will feel some comfort knowing there are others in this trial. If you post here, you might get answers from others in the trial also.
I'm sure it's very frustrating to have to wait for the next step — so sorry. Nonetheless, huge thanks for continuing to share your experience; you are truly a pioneer. Like many, I'll be looking forward to more info on phase 3.
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 »

To follow information on the CTAD Conference next week, check out another thread in the APOE 4 site. There is already information on Lecanemab in the Clarity trial posted there and I am sure next week there will be a lot more.

viewtopic.php?t=8179

"CTAD 2022 -- Endgame for AD"

AND

LECANAMAB: EFFICACY, SIDE EFFECTS, AND MORE. viewtopic.php?t=8303
;) 4/4 “Choose to be optimistic. It feels better.” Dalai Lama
mike
Senior Contributor
Senior Contributor
Posts: 849
Joined: Fri Mar 09, 2018 4:55 pm
Location: CA - Sonoma County

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

Post by mike »

Would it be horrible to apply in order to get a PET scan, but then drop out and wait for the ALZ-801 pre-MCI study?
Sonoma Mike
4/4
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 »

mike wrote: Mon Nov 28, 2022 3:27 pm Would it be horrible to apply in order to get a PET scan, but then drop out and wait for the ALZ-801 pre-MCI study?
Hi Mike,

I can understand your interest in finding out the results of a PET scan for amyloid beta and/or tau. The AHEAD study does both prior to baseline but a key question would be: What will you do with this information if you have it? From reading your posts, you've been very open about having diabetes for 20+ years and being ApoE 4/4 and you seem to have done a great job managing both of those risks. Studies I've seen suggest that a majority of us with ApoE 4/4 are likely to have amyloid plaques by the age of 60 (about 60% at age 60, if I remember correctly).

Since you're interested in a future ALZ-801 prevention study for people with normal cognition, why not just wait a bit for that?

If you are okay with being not-quite honest about your interest in the AHEAD study, you could go as far as the Precivity Blood test, which is reportedly about 80% accurate in predicting a positive PET scan for amyloid. To get to the blood test, you'd need to contact a study site, likely have a phone interview with a coordinator, followed by your first in-person visit with your study partner. Here's the key points on that from an earlier post by Chicagogirl on this thread. viewtopic.php?t=8195
Chicagogirl wrote:VISIT 1A - Approximately 1-2 hours. (There is a 1B, 2, 3, 4, 5)

Had to sign an informed consent for the screening procedures. The Nurse went through the document with me and highlighted the important information on each page. This has to be signed for them to continue (You can back out of the study at any time in the future). I then had a choice of signing another informed consent to learn my APOE status. If you don't want to know your status, you can decline. I already knew my status and said "yes". Then had 9 vials of blood drawn (not so bad).... There were some general questions I had to answer, but no memory questions at this point. Now I wait 3-4 weeks to find out if I have Amyloid in my blood.
But getting that result, after an hour or two of your time, and at least another hour of the nurse's time to set it up and then later contact you with the results, and enter all of that information onto the AHEAD central screening site, seems like a lot for what won't really change your day-to-day life, IMHO.

To get the PET scan, you and your partner would need to come back for Visit 1B; here's what that involved for Chicagogirl. The "cognitive assessments" are extensive tests which most people (myself included when in a trial) find stressful, since they are designed to challenge speed, recall, new learning in both visual-spatial and auditory/verbal areas.
Chicagogirl wrote:VISIT 1B will cover the following: It will last approximately 3 hours, while the study partner's portion would take about 45 minutes.

It will consist of the following:
-Study Partner consent
-Cognitive assessments
-Questionnaires (for you and study partner)
-Vital Signs, ECG, and Physical/Neurological Examabout 4 hours of extensive testing by a neuropsychologist, and then wait until an opening comes up for a PET scan.
When I had a PET scan in 2017, I got almost to the hospital from 2 hours away when they called and said the radioactive tracer was out of range for the temperature requirements, so I had to come back weeks later. PET scans aren't dedicated to this study; they're used by people with all sorts of needs--at a cost of about $5000. I think.

You're not a horrible person to want this info, yet it may not be a magic elixir of info for you.
Nancy
4/4 and still an optimist!
mike
Senior Contributor
Senior Contributor
Posts: 849
Joined: Fri Mar 09, 2018 4:55 pm
Location: CA - Sonoma County

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

Post by mike »

NF52 wrote: Mon Nov 28, 2022 4:31 pm You're not a horrible person to want this info, yet it may not be a magic elixir of info for you.
Nancy, thanks for your response. Not a magic elixir, but information and baseline. Most folks with AD lose brain mass decades prior to symptoms. I got a baseline MRI with Neuroquant five years after my stroke (when I had a standard MRI). Little change between the two and no sign of neuron loss. This tells me I'm likely good for awhile. It was a relief for my wife and I. I used this info to convert our mortgage to a 15 year loan so that it should be paid off prior to symptoms if I'm to get them. IMHO AB plaques are the result of nasties getting through the Blood Brain Barrier and then not getting cleared because of ApoE4. My strategy is to prevent the nasties from getting through the BBB in the first place. I was lucky that I continued to exercise during middle age, which seems key to that. Tested for and treated a mouth/gum bacteria correlated with AD. Keep to a VERY low carb diet, etc. It would be nice to know if my strategy is working, and to get a baseline to see what the direction is going forward. The ALZ-801 would be my backup if my strategy were not working and I had significant AB.
Sonoma Mike
4/4
Post Reply