Just accepted into an AD Study

[reluctantexan]

How did I come here? Looking for alternatives to the drug in the AD Study I'm about to test into.

I've been accepted into an AD Study, GeneMatch knows my apoe4 status, but I do not. It is a Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multi-Center Study. Screening begins next week and can last as long as 90 days. I can withdraw at any time.

I'm 73, walk 3 miles every morning before dawn, eat LCHF and practice IF. I'm rarely out of ketosis. My weight and body fat are normal, as is my A1C. I have no diagnosed disease and take 1mg estradiol daily as my only prescription.

I'll admit to being surprised that I'm included in this Study, but if I do, indeed, have AD, I will be needing SOMETHING.

My plan is to read what you have available here and learn as much as I can.

[Karengo]

Hello relcutantexan! Welcome to our community. Glad you found yourself landing here - whatever the reason. May you find the answers you seek!

My plan is to read what you have available here and learn as much as I can.

I think you will find a wealth of information within our site as well as through the shared knowledge and experience of our members. And you'll notice not everyone actually knows if they may have the gene or not. Like you, they are living in the mystery - myself included for the moment anyway as I've recently gone thru 23&me an awaiting results.

Feel free to explore and post any specific questions you may have as they arise. And your comments are welcome, too. In the meantime, here's a link to our Primer and you can also search the site for topics using Wiki

You have courage to participate in the study. May all go well for you. Please let us know how it goes!
Best,

[reluctantexan]

Thanks for the welcome. Looking around.

[slacker]

Thanks for the welcome. Looking around.

It sounds like you are taking oral estradiol. Studies show that women on oral estradiol are at greater risks for stroke. You may want to switch to an estradiol patch. And if you have a uterus, also take progesterone.

Here is a link to the hormone replacement section of Stavia's Primer.

[reluctantexan]

Thanks for the welcome. Looking around.

It sounds like you are taking oral estradiol. Studies show that women on oral estradiol are at greater risks for stroke. You may want to switch to an estradiol patch. And if you have a uterus, also take progesterone.

Here is a link to the hormone replacement section of Stavia's Primer.

Thanks, but I'm okay with what I've been taking for the past 30 years. "Studies show?" I gave up on being told the truth years ago about any of those studies. Did you know that Medicare won't cover HRT for women over 65 because of those studies? Luckily it's inexpensive. I just had to keep looking until I found an OBGYN willing to write a scrip. No cervix, so that's okay, too. I'll find out more from all the screening tests (and they are myriad.) Maybe I've already had TIA.

[slacker]

Thanks for the welcome. Looking around.

It sounds like you are taking oral estradiol. Studies show that women on oral estradiol are at greater risks for stroke. You may want to switch to an estradiol patch. And if you have a uterus, also take progesterone.

Here is a link to the hormone replacement section of Stavia's Primer.

Thanks, but I'm okay with what I've been taking for the past 30 years. "Studies show?" I gave up on being told the truth years ago about any of those studies. Did you know that Medicare won't cover HRT for women over 65 because of those studies? Luckily it's inexpensive. I just had to keep looking until I found an OBGYN willing to write a scrip. No cervix, so that's okay, too. I'll find out more from all the screening tests (and they are myriad.) Maybe I've already had TIA.

Reluctant, I respect your decision. Our group tries to do a deeper dive on study conclusions and we don't neccessarily accept the party line. We are open to the reality that different studies produce different results, and try to navigate through the uncertainty. You are completely correct on the over-interpretation of the Women's Health Study, and two major menopausal medical organizations (one national, one international) agree with you.

[reluctantexan]

Slacker, forgive my brusque reply, but please understand that I've been fighting the HRT battle for many years. Not only that, but I've been eating LCHF since 1972, while all around me people were making faces and telling me I'm killing myself. You guys here will be fighting the same battle against Big Food and Big Pharma, so I know you understand what it's like.

Those people who thought I was killing myself eating low carb high fat are now T2D, fat and taking all kinds of drugs (which IMO will kill them.) Ironic. I'm sure they don't swim laps and go to the gym or even walk any farther than the handicapped parking spaces into the stores, where they buy more of the food that's already killing them.

Anyway, as Popeye used to say, "I yam what I yam."

[NF52]

How did I come here? Looking for alternatives to the drug in the AD Study I'm about to test into.
I've been accepted into an AD Study, GeneMatch knows my apoe4 status, but I do not. It is a Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multi-Center Study. Screening begins next week and can last as long as 90 days. I can withdraw at any time.
I'll admit to being surprised that I'm included in this Study, but if I do, indeed, have AD, I will be needing SOMETHING.
My plan is to read what you have available here and learn as much as I can.

A warm welcome from Virginia, reluctantexan!

I imagine there's a good story behind the name you chose. My mother was a VERY reluctant Minnesotan for 5 years, mostly because she left her family and a job she loved for a place even colder than western NY due to my father's necessary job change. For me, living in Minnesota opened up whole vistas of experiences that I still value. Sort of like finding out I'm a 4/4: wouldn't have chosen the journey, but love the people I'm meeting and find that life's surprises often bring new depths of learning and appreciation.

My guess is that you have been invited to join in the Generations I or II study. Gene Match is one of the ways that the the Generations study researchers are seeking to identify us very special people, who can help to test two different drugs which MAY delay or prevent mild cognitive impairment or dementia in people at increased risk of both due to their ApoE 3/4 or 4/4 status.

So here's some quick facts:
I'm in the Generations 1 , which is a clinical trials investigating 2 drugs: CAD 106 and CNP 520 and includes only people with ApoE 4/4.
Generations 2 is a very similar clinical trial of only CNP 520 at several different dosages. It includes both ApoE 3/4 individuals (if they are "positive" for amyloid on a PET scan) and ApoE 4/4 folks.

In both studies, participants go through extensive screening which can take up to 90 days, not because you're busy doing things for 90 days, but because it takes a while to schedule expensive things like PET scans and because they want you to have enough time to really be comfortable with the information and the process before you sign a consent for the study--right before you have what is called the baseline visit. Think of it as an extended courtship in which each side gets to know a lot about the other and decide if the want to go ahead with a 5-year relationship!

I trust the nurse practitioner at my site completely, and appreciated it when she called me just last Friday to say that the study doctor would like me to add a B-12 supplement because my blood levels at my recent visit, while well above the official lower limit of "normal" was slightly less than the level of 500 that he likes to see. They promised when I started that if there was ever a time when they thought I should not continue the study for my health, they would tell me, and they would also tell me if they found any information that they thought i should know to optimize my health.
Being in the Generations Study does not mean I cannot also follow many of the recommendations of the Bredesen protocol. They have never told me "Oh you can't take such and such". Only thing I have to "give up" is grapefruit juice, which is not an issue because I never craved it.

If you are accepted into either study you will be randomly assigned by what I think of as the "master computer". About 62% of participants with get one of the two drugs; about 38% will get a placebo. The people at the study site won't know which you have, hence the "double-blind" status: both you and the people you see are "blind" to what you are taking. This is the "gold standard" for an experiment. And since these two drugs didn't cause a lot of side effects, a lack of side effects doesn't mean you got the placebo.

I have found the study staff to be smart, warm, helpful and committed people. I can honestly say that I look forward to seeing them every three months! During 2 of those visits, I only have an updated physical and blood work, and get new bottles of pills. In the mid-year and end-of-year visits, I will add to that repeated cognitive tests, and some imaging tests. My husband, who is my study partner, comes on the "big day" appointments; the others I do on my own. I know of 4 other women on this site who are in the Generations Trial, from 'just starting" to "into her second year." We are ready to support each other whenever needed--even if it's only to say "why did I make the mistake of asking for classic (hard) rock for an MRI?!" One woman's study partner is a long-time close friend, the others are husbands.

Part of the reason for the 5-year trial is to be able to show conclusively whether CAD106 or CNP 520 work on a number of different possible pre-Alzheimer's events. So they do a number of different cognitive tests twice a year to look at possible subtle changes, as well as blood tests 4x/ year, as well as repeat imaging tests. The FDA recently gave guidance to drug companies that proof of efficacy using outcomes other "moved into Mild Cognitive Impairment" or "didn't move into MCI" could still result in fast-track approval of drugs, if they are significant.

My husband's first reaction was something like "Five years! What if we want to go on vacation during an appointment week?" Well, this study is nothing if not motivated to work with you to plan around your schedule, with "26 week" visits, for example, able to occur anywhere in 2-week range. For me, taking one pill a day, at a time I choose, is not a burden. I hope I have the real CNP520, but even if I'm taking a placebo for 5 years, I know that the multiple assessments, imaging and blood work will make a difference in what is known about ApoE4. And since I have 3 grown children who are ApoE 3/4, and 3 siblings who may be ApoE 4/4, this is an effort I feel great about making.

If you go to the search function (the 3 vertical dots on the upper right side, you can search for CNP 520 or for members "lol", "p45va" and "mardi" who are Generations I veterans, and good storytellers! By the way, p45VA is also 73, and has a similar commitment to physical and mental health. I confess to envy of your 3 mile walks before dawn; I often take 3 mile walks, but only got up before dawn when we had a beagle named Wilbur who couldn't make it through the night without a pee run.

Here are a few reports on it:
RATIONALE FOR CNP520 DOSE SELECTION FOR THE PIVOTAL CLINICAL PROGRAM IN PRECLINICAL AD

RESULTS FROM A 3-MONTH STUDY IN HEALTHY SUBJECTS AGED 60 YEARS WITH THE BACE INHIBITOR CNP520

THE ALZHEIMER’S PREVENTION INITIATIVE GENERATION PROGRAM: EVALUATING CNP520 EFFICACY IN THE PREVENTION OF ALZHEIMER’S DISEASE
THE ALZHEIMER’S PREVENTION INITIATIVE GENERATION PROGRAM: EVALUATING CNP520 EFFICACY IN THE PREVENTION OF ALZHEIMER’S DISEASE
And in the "fair-time" mode: here is a link to a brief article in the Lancet from 2016 questioning enrolling healthy Apoe 4/4 subjects on the basis of genetics only, and a reply from the study's lead investigators.

What are we willing to accept for preventing Alzheimer's disease?

Feel free to ask questions of this whole community; you'll find we are a group that rarely agrees on everything, but always agrees that we're here for each other.

[reluctantexan]

This is a new drug. JNJ-54861911
It's reassuring that this Study is following the pattern you described. I'm totally new to this. I want to find out all I can because I have a daughter, and if something can save her, I'll go through this. Don't know if I can make myself take the drug, but I can learn. Until a few days ago, I knew nothing about the Bredesen Protocol. Now I do. I'll learn more every day.
Thank you for taking the time to share so much information with me. I'm grateful.

[NF52]

Hi Pat,
I almost mentioned JNJ-54861911, which is also a BACE-1 inhibitor, like CNP-520, which I take (or the very expensive placebo version!). The JNJ stands for Johnson & Johnson, which I think of as a baby products company. The drug is made by one of their subsidiaries, Janssen, and has been in development and testing for several years. The EARLY trial that is starting in about 200 sites in the U.S. has been in numerous sites in the last couple of years in Europe. I look at that as a good sign, like buying a car after the first model year is over so that you can be more confident it's not a lemon.
I expect that the process will be very similar to what I described; I think the trial length is slightly shorter, at 4.5 years.
Good luck in the new journey. Please share what you learn along the way!