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

[shug]

Thanks for all the support here!

[Chicagogirl]

.
For those who screened for the AHEAD Study, but failed the Amyloid Blood test - This might be of interest to you.

APEX STUDY - The Alzheimer’s Plasma Extension (APEX) Study is an observational study on Alzheimer’s disease (AD) related brain changes. An observational study is where researchers look at (or observe) changes over time without any study treatments. PART 1

A friend received the following letter after screening for the AHEAD STUDY and not having the required amount of Amyloid in her blood:

"In this study, researchers hope to learn about the factors that may preserve memory and thinking in older individuals who do not develop elevated amyloid levels in the brain. The APEX Study consists of one in-person visit every year for four years in which blood samples, memory tests and questionnaires will be collected. Participants may receive $50 per each completed study visit and there is no need for a study partner. Data privacy of APEX Study participants is a top priority. By law, the study is required to maintain the privacy and security of participants’ protected health information.

Participation in this study will help inform future clinical trials for Alzheimer’s disease by helping researchers identify changes in blood tests, memory, and brain health that may occur years before people develop elevated brain amyloid and cognitive impairment.

If you are interested in participating, the study team will invite you to the first visit (called the “Initial Visit”) to review and discuss an informed consent form that explains the study in greater detail. The study team will also answer any questions that you may have before signing the consent form.

Your participation is completely voluntary, and you have the right to change your mind and leave the study at any time."
.

APEX_Study_General_A.jpg

.

APEX_Study_General.B3.jpg

.

See additional flyers in 2nd post.
.

[Chicagogirl]

APEX STUDY - The Alzheimer’s Plasma Extension (APEX) Study is an observational study on Alzheimer’s disease (AD) related brain changes. An observational study is where researchers look at (or observe) changes over time without any study treatments -
PART 2
.
As mentioned in the above post this is a study based on participation in the AHEAD clinical trial, where the participant did not have enough Amyloid in the blood test.

Additional flyers (had issues getting all to post at once)
.
.

APEX_Study_-_FAQ.B.jpg

.
.

APEX_Study_-_FAQ.A.jpg

.
.

There is also a website: https://www.actcinfo.org/alzheimers-pla ... pex-study/

This is a great opportunity for those who screened in the AHEAD study to continue the relationship with the site that did their original testing. Hope you will consider this if you are contacted for the study. They also state (website): "Researchers will carefully monitor your brain health and it is an opportunity to ask questions related to your brain health. You may also learn of other research opportunities that you may be suitable for".
.
The "APEX Study seeks individuals from all races, ethnicities, genders, sexual orientations, economic backgrounds, and geographies to increase our understanding of AD". Other than that, I don't know what other screening criteria they are using.

Let us know if you are participating / screening for the APEX study.

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

[Chicagogirl]

.
Visit 37 – Week 62 (32nd infusion)

Visit 38 – Week 64 (33rd infusion)

Visit 39 – Week 66 (34th infusion)

Visit 40 – Week 68 (35th infusion)

These infusions were done by my Home Health Nurse. I’ve previously mention what a benefit being able to have this done at home is to me. I’m hoping that many of you in this trial have also been able to experience this.

My next visit (at home) is:

Visit 41 – Week 70 (36th infusion)

The next day will be my scheduled MRI #7.

Visit 42 – Week 72 (37th infusion) – Memory & Thinking Skills Test, Blood Tests (Back at the Center)

I will reach my 2-year mark in February. At that time, I will have Memory tests, etc. and then MRI #8, Amyloid PET scan and TAU PET scan. I will either go on once every four weeks infusion schedule or find out my Amyloid and Memory is worse.

At times it has seem like forever, but recently when I look back it doesn’t seem like I am approaching the 2-year mark, and that you have been following me in this journey.

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

[Nevada]

A couple of hiccups
I’m now 155 weeks into the Ahead study. In July, I contracted Covid-19 for the first time and missed an infusion and other testing. Then in August, there was concern after the independent evaluation of my MRI at MAYO detected what they thought was a fourth microhemorrhage. My wife and I met with my local neurologist who reviewed the images with us and was certain that there were 3 microhemorrhages which had all been previously detected, but was not in agreement with the Mayo determination of four. In any case, my local neurologist suspended infusions until I obtained an “extra” MRI (my 13th) to make sure that I did not clearly demonstrate 4 or more microhemorrhages which according to the research protocol might require discontinuation of any further infusions depending on various factors including the judgement of my local neurologist.
This was all disappointing and disconcerting news to me after participating in the study for 3 years. However, I have to appreciate the cautiousness of the study staff. As I have previously mentioned, I suspect I am receiving placebo infusions. If correct, then the microhemorrhages are not caused by Leqembi, but I will not know that for sure until the entire study is completed. Tomorrow, I will resume infusions so I’m still hanging in there…

[NF52]

A couple of hiccups
I’m now 155 weeks into the Ahead study. In July, I contracted Covid-19 for the first time and missed an infusion and other testing. Then in August, there was concern after the independent evaluation of my MRI at MAYO detected what they thought was a fourth microhemorrhage. My wife and I met with my local neurologist who reviewed the images with us and was certain that there were 3 microhemorrhages which had all been previously detected, but was not in agreement with the Mayo determination of four. In any case, my local neurologist suspended infusions until I obtained an “extra” MRI (my 13th) to make sure that I did not clearly demonstrate 4 or more microhemorrhages which according to the research protocol might require discontinuation of any further infusions depending on various factors including the judgement of my local neurologist.
This was all disappointing and disconcerting news to me after participating in the study for 3 years. However, I have to appreciate the cautiousness of the study staff. As I have previously mentioned, I suspect I am receiving placebo infusions. If correct, then the microhemorrhages are not caused by Leqembi, but I will not know that for sure until the entire study is completed. Tomorrow, I will resume infusions so I’m still hanging in there…

Hi Nevada!

Gotta say, I admire how you hardy Westerners deal with earthquakes and wildfires and COVID and disagreements between radiologists over how many ARIA-H "isolated" micro-hemorrhages showed up on your MRIs as "hiccups". After 155 weeks, about 12 weeks "ahead" of me, you should be entitled to boring visits. I too had COVID in 2021, right after the first MRI that showed ARIA-H, so I got a 6 week break out of that! I view this as a marathon in which a short break doesn't throw the race--and the data from people in CLARITY seems to support that.

Weirdly, (a great word lately), my home team and the Mayo Clinic also disagreed on this, with the Mayo team finding 3 microhemorrhages in all, two at month 7 and one at month 16, while the home team (i.e. study site's hospital radiologist) saw them all as "possible". So they compromised and I now have 3 "possible microhemorrhages" on my chart and no changes in my cognitive skills. Each is by definition < 5 mm.

But for both of us, having them isn't proof that we're on lecanemab OR that we're on the placebo. In the CLARITY study, about 11% of people with ApoE 4/4 on lecanemab for 18 months had "isolated ARIA-H" without having ARIA-E (edema) at the same time. On the placebo, the percentage was 18% for isolated ARIA-H. That's 11% and 18% of only 17% of the whole 1800 people in the study, so I don't know if the difference is meaningful. Not having symptoms also doesn't mean you're not on the drug, since I think the figure for asymptomatic ARIA-E or ARIA-H on lecanemab in CLARITY was about 80%.

The isolated ARIA-H in both cases occurred sporadically, not just in the first 6 months when the combined ARIA-E/ARIA-H was most common. As I understand it, the assumption is that whether on the drug or placebo, our capillaries are just a little more likely to be prone to minor leaks.

The decision to suspend if you have 5 micro-hemorrhages may be your site's protocol, and not a directive from AHEAD, so you might want to check into that. My site doctor said it was a case-by-case decision and the only person who had to exit AHEAD at my site was for ARIA-E recurrence.

At about the end of the third year, your brain must be humming along nicely!

Nancy

[Nevada]

Nancy: Thanks for your support and added information about the CLARITY study ARIA statistics. Yes, according to study staff the "maximum" number of microhemorrhages is not a hard stop for infusions. A number of factors inform that decision. For instance, I had 1-2 microhemorrhages at baseline. Yesterday, I was informed that my most recent cognitive evaluation showed no significant changes even though I felt a bit more "foggy" than usual for a while after my bout with Covid-19. That is reassuring. Interestingly, study staff "feel" that I am likely receiving Lecanemab even though I think it is more likely to be placebo. I suppose my bias is partly based on previous research that I have conducted on the Placebo effect in my professional life, and the fact that I was in the placebo group when I was a participant in the Generation study (CNP520). Nevada

[NF52]

Nancy: Thanks for your support and added information about the CLARITY study ARIA statistics. Yes, according to study staff the "maximum" number of microhemorrhages is not a hard stop for infusions. A number of factors inform that decision. For instance, I had 1-2 microhemorrhages at baseline. Yesterday, I was informed that my most recent cognitive evaluation showed no significant changes even though I felt a bit more "foggy" than usual for a while after my bout with Covid-19. That is reassuring. Interestingly, study staff "feel" that I am likely receiving Lecanemab even though I think it is more likely to be placebo. I suppose my bias is partly based on previous research that I have conducted on the Placebo effect in my professional life, and the fact that I was in the placebo group when I was a participant in the Generation study (CNP520).

I was also on the placebo in the Generations trial. It’s tough to have to wait for probably another few years to learn what all those infusions contain! I’m convinced that the wait is worth it to learn if prevention before symptoms begin works.

[Chicagogirl]

Nancy: Thanks for your support and added information about the CLARITY study ARIA statistics. Yes, according to study staff the "maximum" number of microhemorrhages is not a hard stop for infusions. A number of factors inform that decision. For instance, I had 1-2 microhemorrhages at baseline. Yesterday, I was informed that my most recent cognitive evaluation showed no significant changes even though I felt a bit more "foggy" than usual for a while after my bout with Covid-19. That is reassuring. Interestingly, study staff "feel" that I am likely receiving Lecanemab even though I think it is more likely to be placebo. I suppose my bias is partly based on previous research that I have conducted on the Placebo effect in my professional life, and the fact that I was in the placebo group when I was a participant in the Generation study (CNP520).

I was also on the placebo in the Generations trial. It’s tough to have to wait for probably another few years to learn what all those infusions contain! I’m convinced that the wait is worth it to learn if prevention before symptoms begin works.

.
Nevada…

Fiber company who is installing new service in our neighborhood cut the current line to our house on Tuesday the 10th. Due to the CWA strike in the southeast, they can’t get to our house until the 24th to repair. My kind son-in-law came over last night with a cradlepoint (new term to me) that looks like a spider with 8 legs and it has given me minimal internet service. But good enough to respond to your post.

I was so sorry to hear that they think that you have had 4 microbleeds. But as you, I would appreciate the cautiousness of the study staff. Hoping that they decide that you can continue in the study. After 3 years of being in the study I would feel very disappointed if I had to stop.

You mentioning getting Covid in July, it pushed me to schedule my appointment for this weekend.

NOT SURE EVERY SITE SAYS THIS: I confirmed with the AHEAD STUDY monitor, and I have to have any vaccines either 5 days before or 5 days after an infusion.

Nancy…..

I always appreciate the wealth of information that you have and your willingness to share it. You have the ability to make the technical stuff easy to digest. Always with a slight sense of humor and humanity in the answer.

Best wishes to both of you and thanks for the information.

Chicagogirl
.

[shug]

I mentioned in July I "flunked out" of the AHEAD study, with blood biomarkers positive for amyloid but not enough to be visible on petscan. I just had my first of the annual APEX visits. Just a blood test and a (short) cognitive test. I'm happy to be back at the study site and still involved.