Clinical Trials

Insights and discussion from the cutting edge with reference to journal articles and other research papers.
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SusanJ
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Re: Clinical Trials

Postby SusanJ » Fri Feb 23, 2018 8:46 am

rrao2015 wrote: Affirmativ health's RE:mind Program


Just went to the link. I'm guessing it's very expensive since they don't have any pricing listed. And they say:

Don’t let financial concerns keep you from taking action. Taking steps toward improving your cognitive health if you are already experiencing memory issues or reducing your risk for Alzheimer’s disease shouldn’t have to wait. We have financing available to help you get started immediately.


Some of our members have to watch costs carefully. Any ideas on how much this program costs?

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ru442
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Re: Clinical Trials

Postby ru442 » Fri Feb 23, 2018 9:13 am

According to the site it is sold out...
Male 4/4 56 yrs., "Live, Laugh, Love"

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Re: Clinical Trials

Postby NF52 » Fri Feb 23, 2018 9:58 am

SusanJ wrote:
rrao2015 wrote: Affirmativ health's RE:mind Program


Just went to the link. I'm guessing it's very expensive since they don't have any pricing listed. And they say:

Don’t let financial concerns keep you from taking action. Taking steps toward improving your cognitive health if you are already experiencing memory issues or reducing your risk for Alzheimer’s disease shouldn’t have to wait. We have financing available to help you get started immediately.


Some of our members have to watch costs carefully. Any ideas on how much this program costs?

Here's the answer to your question, Susan:
Affirmativ Health’s three-month program is $9,950, which includes a four-day immersion workshop (including all lodging, meals, and consultations), two personalized protocol reports (one at the workshop and another at the end three month mark), and telephone – and/or video-based wellness support to help you achieve your goals. Travel, laboratory tests, supplements, and medications are not included in the initial cost. The initial laboratory testing costs approximately $1,000....We provide coaching and ongoing support that will help you make and reach goals for lifestyle change. The goal is to continue these lifestyle modifications and choices on a continual basis...Although we cannot guarantee outcomes and do not claim the program to be a cure, this personalized program has shown positive effects for many people in its early phase and a recent publication has shown very encouraging results for improvement in cognitive decline with a similar program.
[Emphasis added.]
https://affirmativhealth.com/faqs/

https://www.prnewswire.com/news-releases/dr-dale-bredesen-announces-termination-of-his-relationship-with-muses-labs-inc-300188947.html FWIW, Dr. Bredesen ended his association with MUSES lab, the lab partner here, in 2015.
I believe that Dr. Rao sincerely wants to help people improve and maintain their health and wellness. Recommending this program, with a cost of $12,000 (including two blood labs) plus the cost of travel, when they cannot point to clear evidence, but merely cite a "similar program" in an unnamed "recent publication" seems a boundary-nudging of the Trust guideline of this community:
"Trust. Ulterior financial interests complicate our interactions. Do not self-promote or advertise."

And it is not a Clinical Trial, the subject of this thread, in any manner, way or form.
4/4 and still an optimist!

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Julie G
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Re: Clinical Trials

Postby Julie G » Fri Feb 23, 2018 11:52 am

NF52, thanks for keeping us on our toes! It's hard for the mods to keep up with every post. I agree that Dr. Rao meant only the best by sharing this opportunity. That said, I will move ithe link to our wiki, where we share APOE4-aware healthcare practitioners, groups, etc.

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Re: Clinical Trials

Postby BEM » Mon Feb 26, 2018 8:07 am

Thank you MarkL
I spoke to 2 different studies in Boston but I am still too young. So frustrating...I would think that starting with those of us who are young(56) would be good for studying the progression...and work on prevention through diet, exercise and lifestyle. I guess I will just make efforts on my own until I turn 60. It seems a great loss not to study those of us in our 50's. But for now I will try to live my life the best I can and try to focus on today and not what may lay ahead. Thank you all for your support.

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Re: Clinical Trials

Postby Orangeblossom » Tue Feb 27, 2018 3:14 am

For anyone in the UK there is this NHS link here to research you can sign up to. it doesn't commit you to anything.

https://www.joindementiaresearch.nihr.ac.uk

You can add about your APOE4 status and other info in there.

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Clinical Trials and Generations Study

Postby Indywoman » Sat Mar 03, 2018 9:22 am

Well, I am in that horrible place of sadness, fear, and panic. I am 64 years old, have 4/4 homozygous, and am considering entering a randomized double blind, placebo controlled 2 cohort parallel group study to evaluate the efficacy of CAD106 and CNP520. It is part of the Generations study. I just found out about my homozygous 4/4 status a month ago, having a sneaking worry given some small, but still recurring short term memory lapses in the past year, and a somewhat fatalistic attitude since my mother had Alzheimer's starting at 73.
Given that these are 5 year studies, I don't know if I should commit to that long a time frame given that it might foreclose other options, nor can I find a lot on the safety of previous trials of CNP520, although there is more on CAD106.
Any advice from professionals or others who chose to do the Generations study?
4/4. Do something today that your future self will thank you for.

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Re: Clinical Trials and Generations Study

Postby slacker » Sat Mar 03, 2018 11:03 am

Indywoman wrote:Well, I am in that horrible place of sadness, fear, and panic. I am 64 years old, have 4/4 homozygous, and am considering entering a randomized double blind, placebo controlled 2 cohort parallel group study to evaluate the efficacy of CAD106 and CNP520. It is part of the Generations study. I just found out about my homozygous 4/4 status a month ago, having a sneaking worry given some small, but still recurring short term memory lapses in the past year, and a somewhat fatalistic attitude since my mother had Alzheimer's starting at 73.
Given that these are 5 year studies, I don't know if I should commit to that long a time frame given that it might foreclose other options, nor can I find a lot on the safety of previous trials of CNP520, although there is more on CAD106.
Any advice from professionals or others who chose to do the Generations study?


Welcome Indy;

Many of us are overwhelmed once our ApoE4 status is discovered. I applaud your desire to further medical science by participating in a study. There is much you can do to help prevent cognitive decline in the meantime. You may want to start with our Primer, written by an MD member; it is a wealth of information for prevention and improvement of cognition. Little by little, most find hope and community with us.

NF52, who posted earlier in this thread, is a great resource on clinical trials. One other thread specifically on the Generation Studies can be found here. There are other threads discussing other clinical trial options; you can find them by using our search engine, which is under the 3 vertical dots found in the upper right hand corner. It can be a little tricky figuring out the best search terms, but you may find the results of interest.

We are here to support each other. Again, welcome.
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Re: Clinical Trials and Generations Study

Postby NF52 » Sat Mar 03, 2018 11:36 am

Indywoman wrote:Well, I am in that horrible place of sadness, fear, and panic. I am 64 years old, have 4/4 homozygous, and am considering entering a randomized double blind, placebo controlled 2 cohort parallel group study to evaluate the efficacy of CAD106 and CNP520. It is part of the Generations study. Given that these are 5 year studies, I don't know if I should commit to that long a time frame given that it might foreclose other options, nor can I find a lot on the safety of previous trials of CNP520, although there is more on CAD106.
Any advice from professionals or others who chose to do the Generations study?


Hugs from a 4/4 "sister" in Virginia, Indywoman,

I've been in that place of sadness, fear, and panic. Most of us have in one way or another, and I think almost all of us will tell you "it gets better". Part of the reason it gets better is you realize you're not alone--you have the support of this group, you probably have family support, and you have people who are working super-hard to find interventions to delay, prevent and/or ameliorate the risk factors of ApoE 4/4.

So here's some quick facts:
I'm in the Generations 1 study. [There is also a Generations 2 study which includes both ApoE 3/4 individuals (only if ApoE 3/4 volunteers are also "positive" for amyloid on a PET scan) and ApoE 4/4. Generations 2 is studying several different dosages of CNP 520 only.] About 62% of participants with get one of the two drugs, randomly assigned by the "master computer" as I think of it, and 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.

The screening process takes a few months; they want to give you time to be sure you want to join. You will be given clear information in detailed consent forms and verbal conversations with study site staff. They are clear that you can drop out at any time, and that they will notify you if they feel that for medical or other reasons you should not continue. They also promise to notify you of any developments that might be important to you. 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 "authors" "lol", "p45va" and "mardi" who are veterans, and good storytellers!

Here are a few reports on it:
RATIONALE FOR CNP520 DOSE SELECTION FOR THE PIVOTAL CLINICAL PROGRAM IN PRECLINICAL AD
https://www.sciencedirect.com/science/article/pii/S1552526017331618

RESULTS FROM A 3-MONTH STUDY IN HEALTHY SUBJECTS AGED 60 YEARS WITH THE BACE INHIBITOR CNP520 http://aanddjournal.net/article/S1552-5260(17)30351-5/fulltext

THE ALZHEIMER’S PREVENTION INITIATIVE GENERATION PROGRAM: EVALUATING CNP520 EFFICACY IN THE PREVENTION OF ALZHEIMER’S DISEASE
http://www.jpreventionalzheimer.com/2803-the-alzheimers-prevention-initiative-generation-program-evaluating-cnp520-efficacy-in-the-prevention-of-alzheimers-disease.html

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?
http://www.thelancet.com/pdfs/journals/laneur/PIIS1474-4422(16)30054-0.pdf

Feel free to ask any questions, and to send me a Private Message if you want.
We're all with you in this new land!
4/4 and still an optimist!

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Re: Clinical Trials and Generations Study

Postby Jena S » Sat Mar 03, 2018 1:43 pm

Indywoman wrote:Well, I am in that horrible place of sadness, fear, and panic. I am 64 years old, have 4/4 homozygous, and am considering entering a randomized double blind, placebo controlled 2 cohort parallel group study to evaluate the efficacy of CAD106 and CNP520. It is part of the Generations study. I just found out about my homozygous 4/4 status a month ago, having a sneaking worry given some small, but still recurring short term memory lapses in the past year, and a somewhat fatalistic attitude since my mother had Alzheimer's starting at 73.
Given that these are 5 year studies, I don't know if I should commit to that long a time frame given that it might foreclose other options, nor can I find a lot on the safety of previous trials of CNP520, although there is more on CAD106.
Any advice from professionals or others who chose to do the Generations study?


Hi Indywoman,

Welcome to the forum! I first want to give you the upmost applause for reaching out to the group and expressing the current emotions you are feeling. This is an amazing group full of supportive peers, medical professionals, and researchers who are here to support and guide you as needed. As Slacker mentioned, the Primer (under Home -> Getting Started) has an abundance of information you may find valuable. The forums have a variety of topics with many responses and viewpoints as well. Please reach out if there is anything we can do for you!


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