CAD106 and CNP520

[Indywoman]

I just saw these posts from yesterday, and burst into tears. Those tears are ones of sadness for all the wonderful people like blp and NF52, who have so bravely forged ahead, taking endless tests, traveling long distances, and getting spouses on board. The time and testing is tremendous and matters greatly, but it the hope that got crushed, hope that we all shared, but born especially by those in the study who put not just their bodies but their emotions on the line.

Having gone through a clinical trial in my 30's for recurrent miscarriages, I understand the fragility of emotions. Not knowing whether one is getting the placebo or the real drug weighs heavily-- feeling vulnerable in a hospital gown, -- being put through a clanking machine and feeling exposed, not to rays but to a sad, ineffable helplessness .

I would also like to add that in 2016, I taught the daughter of a top Eli Lilly researcher working on Solanezumab, the experimental drug that also failed. I did not know my ApoE4 status then, but I knew something was wrong with this wonderful student in my class whose behavior was 'off'. When I asked her privately what was wrong, she said her mother (the researcher) was heartbroken, not just because she had poured her heart and soul into this drug's development and it had failed, but that her mother was wrenchingly sad for the participants in the trial whose hopes were dashed. She said her mom had felt so much grief for how the participants must be feeling when notified, that she had vomited for two days feeling that she had let them down.

So, for the brave people who entered this clinical trial, I wrap my arms around you in solidarity. Know too, that there are many researchers and involved personnel at the study sites that are feeling your sadness too, like the Eli Lilly researcher and mother of my student.

[NF52]

...

I am scheduled for Monday, July 15, for the PET scan results. I hope that will not be canceled. Guess I’ll find out today. I have a call in to confirm my Monday Doctor appointment to discuss the results of the PET scan. Hope they get back to me. It is a 100 mile drive one way.

I just saw these posts from yesterday, and burst into tears. Those tears are ones of sadness for all the wonderful people like blp and NF52, who have so bravely forged ahead, taking endless tests, traveling long distances, and getting spouses on board....

So, for the brave people who entered this clinical trial, I wrap my arms around you in solidarity. Know too, that there are many researchers and involved personnel at the study sites that are feeling your sadness too, like the Eli Lilly researcher and mother of my student.

Words don't do justice to your tears and your kindness. Life goes on for all of us (and today that meant getting a new haircut for "therapy"). I can't speak for other sites, or people at other stages in the trial, but found out today that I will still have an EKG, blood work, all those cognitive tests, and possibly a few new ones (please don't let it be "draw a horse") at the 2 year mark and another round in March 2020 along with an MRI as a final assessment. Apparently, we may be too valuable to stop studying just because we stopped the placebo or study drug.

But I will "borrow" some words that I read yesterday in an article in Vox about the slot canyons of Page, AZ, a place of surreal beauty and deep cultural importance to the Navajo people that my husband and I were able to visit with a small group in 2017. The comment, from an environmental activist, Edward Abbey, resonated with me as true of the journey of anyone with ApoE4, whether we are in a clinical trial or in a daily "trial" of decisions that we hope ensure success long term.

May your trail be crooked, winding, lonesome,dangerous, leading to the most amazing view...where something strange and more beautiful and more full of wonder than your deepest dreams waits for you -- beyond that next turning of the canyon walls.

We can all choose to look beyond today's disappointments and recognize that we may be on Frost's "The Road Less Traveled", a road filled with amazing people, experiences, views and more wonders than our deepest dreams--no matter the outcome.

[chrissyr]

Deep gratitude for all who contributed, these studies are vital for continued knowledge and progress toward treatment. We appreciate
the efforts, time, and investment involved! {{{ }}}

[Verax]

I am 4/3 and volunteered for Generation 1 through Banner, but after undergoing tests and scans was not entered in the clinical trial of CNP520 or placebo, because the scans and CSF didn't show enough amyloid beta. Of course, that was good news for me, as it reduced my chances of imminent LOAD. But I was assured that data would be shared, for example to refine the tracer techniques in the scans, so I was glad to try to help.

Last month, before the drug study was cancelled, I learned that at least one arm of Generation 1 continues without drugs, as a longitudinal observational study for some 1800 Generation 1 participants to follow up for five years with memory testing alone the natural history of those with 4/3, including those with normal memory, scans, and tests. This is important, as diagnosis of AD before autopsy has been uncertain and tests lack specificity and sensitivity. It is essential to try to refine predictions of disease in order to prevent instead of trying to treat.

I can say that I and my study partner have joined that Novartis study, which will continue for five years despite cancellation of the drug arms of Generation 1. That means that I can't also be subject in any other clinical trial for that time. The study will not share yearly memory testing results with me or my physician, but I can drop out at any time. Since no drug intervention is involved, there is no harm. The memory testing is similar or the same as earlier. Travel is paid. Maybe it helps, maybe it also fails. But I did want to encourage those who know their APOE4 results to join together and keep up the good work as here.

[NF52]

I am 4/3 and volunteered for Generation 1 through Banner, but after undergoing tests and scans was not entered in the clinical trial of CNP520 or placebo, because the scans and CSF didn't show enough amyloid beta. Of course, that was good news for me, as it reduced my chances of imminent LOAD. But I was assured that data would be shared, for example to refine the tracer techniques in the scans, so I was glad to try to help.

Last month, before the drug study was cancelled, I learned that at least one arm of Generation 1 continues without drugs, as a longitudinal observational study for some 1800 Generation 1 participants to follow up for five years with memory testing alone the natural history of those with 4/3, including those with normal memory, scans, and tests. This is important, as diagnosis of AD before autopsy has been uncertain and tests lack specificity and sensitivity. It is essential to try to refine predictions of disease in order to prevent instead of trying to treat.

I can say that I and my study partner have joined that Novartis study, which will continue for five years despite cancellation of the drug arms of Generation 1. That means that I can't also be subject in any other clinical trial for that time. The study will not share yearly memory testing results with me or my physician, but I can drop out at any time. Since no drug intervention is involved, there is no harm. The memory testing is similar or the same as earlier. Travel is paid. Maybe it helps, maybe it also fails. But I did want to encourage those who know their APOE4 results to join together and keep up the good work as here.

Wonderful news, Verax! Thank you and your study partner for doing this and sharing. Continued monitoring for 5 years of 1800 people who went through all the screening testing for Generations 1 or 2 but didn't enroll will be a gold mine of information of what happens during those crucial years starting ages 60-75.

Here's my "blue-sky" fantasy: a conference "meet-up" sponsored by Novartis (with travel and hotel rooms paid for) for all those 1800 folks and the ones currently taking CNP520 who just got the news. Bring the power of this community (ApoE 4-holders) to the greater public, and set an example for study subjects having a greater role and transparency to ask questions and hear what went wrong, what has been learned so far, and what questions continued monitoring will answer. Think of the visual of a couple thousand cognitively healthy seniors with ApoE 4 in one place!!

[Verax]

NF52 and Julie, you have been a wonderful inspiration.

I did want to add a comment on the "All Things Considered" NPR piece that aired July 12, 2019.
https://www.npr.org/sections/health-sho ... istressing "A Genetic Test That Reveals Alzheimer's Risk Can Be Cathartic Or Distressing" by Jon Hamilton.

It tells a story familiar to all of us with Apoe4, but came out unluckily at the same time the drug studies were cancelled. Consequently, it tries to ring a positive note by linking to the Banner Generation Program website, which now reads only, "Thank you for your interest in Generation Program. Enrollment has closed."

Thank you, Banner, Amgen, Novartis, for the Generation Program.

I'll leave it to others to correct NPR. I just want to say that several studies some time ago revealed that worries were unfounded that people would fail to understand or would take badly new information about Apoe status, despite the lack of treatment. The majority can handle the news even without extensive genetic counseling. That is why you and I are here. Even so, the Generation Program did do the right thing in finding those at higher risk because of Apoe status and aiming clinical trials at us. I am sure the CNP520 program end does not mean that we should be distressed. Our response has been overwhelming, to meet new friends like us, who will fight together against our common enemy. And it goes on, with or without drug companies, governments, or media such as NPR, we are no longer alone and abandoned.

Thank you Julie for apoe4.info and all of you for sharing.

[Indywoman]

Verax said:
Even so, the Generation Program did do the right thing in finding those at higher risk because of Apoe status and aiming clinical trials at us. I am sure the CNP520 program end does not mean that we should be distressed. Our response has been overwhelming, to meet new friends like us, who will fight together against our common enemy. And it goes on, with or without drug companies, governments, or media such as NPR, we are no longer alone and abandoned.

I’m hoping my empathy for those finding out the news wasn’t interpreted as imagining all participants licking their wounds and crawling into a corner. My main purpose was to show that there are real people behind the research at these drug companies who feel connected to the participants in the trials, and who have chosen to work at research labs to help make a difference. I spoke to many of them, as they were the parents of my students. These researchers working in these labs most certainly believe in the power of science, but science combined with making modifications in lifestyle factors as well. Three of these Alzheimer’s researchers at Eli Lilly are in my Zumba classes, where afterwards, still sweaty, we talk about epigenetic factors, cardio exercise and diet. These hard-working, good-hearted scientists should not be thrown onto a scrap heap of labeling everything under one catch-all, monolithic phrase- Big Pharma.

I also think it is vitally important to acknowledge the real letdowns that follow disappointing results. Some cry mightily at first, others like NF52 get a therapeutic haircut (wow, I would have binged on at least a full sleeve of Oreos or perhaps five Butterfinger candybars). From my anecdotal experience in a clinical trial, most understand that entering a study is risky and know they are trying to beat the odds. Most also understand that as NF52 said, “Failure in science is not just a given, it is a necessity.” Nonetheless, the letdown is real and in varying degrees painful. You soldier on, then you reassemble yourself and resume living. Ultimately, you feel pride in having been part of a like-minded cohort, knowing the data will be helpful regardless of your own outcome. How grateful I am to all of you for entering these studies! How beholden I am for all the people who made my asthma inhaler possible, not to mention my all time favorite pharmacological breakthrough, -the birth control pill.

It was then, great news today, to read the posts about Novartis’ decision to monitor the 1800 participants for the next five years who went through all the screening and testing but weren’t enrolled. NF52’s “blue sky fantasy” is perfect, getting those folks together and maybe, just maybe, the ones who also just got the news on CNP520. Sheer power in numbers with more media visibility, solidarity, and questions and suggestions for the researchers, as well as getting answers to what will be done with the monitoring. ¬¬Go for it!

[NF52]

... My main purpose was to show that there are real people behind the research at these drug companies who feel connected to the participants in the trials, and who have chosen to work at research labs to help make a difference. I spoke to many of them, as they were the parents of my students. These researchers working in these labs most certainly believe in the power of science, but science combined with making modifications in lifestyle factors as well...

I also think it is vitally important to acknowledge the real letdowns that follow disappointing results. Some cry mightily at first, others like NF52 get a therapeutic haircut (wow, I would have binged on at least a full sleeve of Oreos or perhaps five Butterfinger candybars)....How grateful I am to all of you for entering these studies! How beholden I am for all the people who made my asthma inhaler possible, not to mention my all time favorite pharmacological breakthrough, -the birth control pill. ...

Yes, and yes: the story of the researcher who was devastated and physically ill for two days when Solanezumab failed is important to hear. I could hear the efforts of the Generations nurse practitioners to not let their disappointment show when I spoke to them. Just weeks ago the director at my site spoke to me about his own mother moving into Memory Care, about his decision to be tested, "because if I had ApoE 4 I would want to be in a study" and his disappointment that studies have not been able to help people--especially those with diagnoses of AD. He added, "of course, we also recommend lifestyle and non-drug interventions for people to prevent MCI and AD. It's just that for some people we're going to need more."

And I never said that the hair appointment was my only therapy!! Less said about that the better--although it did require both chocolate and hacking away at vines with sharp pruning shears.

And as someone whose maternal family has branches with 11 and 15 children, I too am thankful for having a little more choice in that area thanks to the researchers in planning our fertility.

Thankfully, people with ApoE4 can use this site and other resources and be confident enough, I hope, to say about ApoE 4: "Yeah, I have a plan for that!"

[hairyfairy]

At the end of May I volunteered to take part in a recognition study on alzheimer`s risk for apoe4`s. They took swabs for genetic samples & gave me a questionaire to fill out. I havwn`t heard back from them yest.

[NF52]

At the end of May I volunteered to take part in a recognition study on alzheimer`s risk for apoe4`s. They took swabs for genetic samples & gave me a questionaire to fill out. I havwn`t heard back from them yest.

Great news! I know you had been thinking of participating in a study. This one sounds like an “observation” study in which no drug or treatment is used. Instead, they may be looking for differences in how people with APOE4 do on facial recognition (I’ve always been dismal!) or some other area that might change over time.
Keep up posted!! And hope it’s finally cooler in the UK!