Just accepted into an AD Study

Newcomer introductions, personal anecdotes, caregiver issues, lab results, and n=1 experimentation.
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Re: Just accepted into an AD Study

Post by NF52 »

reluctantexan wrote:23andme results are in. Promethease Report in. I appear to be one of the luckiest people in any gene pool. Maybe I just can't read the results properly. APOE E3/E3, no variants for any diseases. Makes me wonder how I got into this AD Study. Does 23andme ever get the wrong results?
Congratulations on happy results from 23 & me!! My guess is that 23&me got it right and that the EARLY trial of JNJ-54861911 has also not made a mistake: they are more interested in the fact that you're a healthy 73 year old with a family history of dementia.

On the EARLY trial, you don't have to have ApoE 4, but if you don't have ApoE 4, you do have to have a first degree relative (parent, sibling) who had some kind of dementia because parental history of dementia is itself considered an independent risk factor for dementia.

And that's just to get into the screening portion of the study, which is what you've been "accepted into." [That was confusing for me too when I was "accepted" and signed consent for the Generation 1 Screening. I didn't realize there would be a whole separate consent for the actual study,]

The four hours of tests you had recently is indeed exhausting, but at least you know you "passed" as cognitively AOK! They now want you to go on to the MRI, mostly to be sure you don't have any factors that would prevent you from safely participating in the study, or some early indications of changes that would keep you from being included.

After that is the PET scan (which I found very relaxing: think warm blanket and a quiet machine, in comparison to the MRI clatter). The EARLY trial does want to find a "positive" result for amyloid in the brain. Having amyloid in the brain at age 73 doesn't mean you're going to get AD; 30% of people without dementia who donated their brains to an AD study, were found to have positive amyloid while being "asymptomatic" for mild cognitive impairment or dementia.

The reason they want to have a positive amyloid result (I think for both Apoe 4 and Apoe 3's) is to "prime the pump" for their drug, which is designed to reduce amyloid to very low levels.

I would suggest that you call the Study Coordinator and ask about the 23 & me results, and clarify if it's true that you need to have a positive amyloid result on the PET scan. I am sure they gave you a cheek swab on your first visit, and they know that you're a 3/3 also.
Here's the source from Clinical Trials.gov for this info on the EARLY trial:
https://clinicaltrials.gov/ct2/show/NCT ... 911&rank=3

Best of luck whatever you decide!
Last edited by NF52 on Fri May 04, 2018 10:41 am, edited 1 time in total.
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Re: Just accepted into an AD Study

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You have so much info. Thanks for sharing.
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Re: Just accepted into an AD Study

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The dermatologist's office person finally called today and my appointment (next piece of the AD Study screening) is May 18. We're moving right along.
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Re: Just accepted into an AD Study

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Great news! Smart study to look BEFORE you start taking things to see if you have any interesting skin issues.
I have a history of sun-related damage, mostly to my nose. Luckily for me, it's not a requirement of the study that I move back to a climate with long winters and cloudy summers to avoid more sun exposure. That would have been a deal-breaker. ;)
( I do carry SPF 70 the way other people carry snacks.)
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Re: Just accepted into an AD Study

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Hello, everyone, not sure this is the right spot to share my study information gleaned and summarized from consent docs. Feel free to move this post as appropriate.

I have now been accepted into 3 separate studies.

The first study, now complete, was a small, brief (2 full days) Meal and Memory study with multiple blood draws and lumbar puncture while digesting a high carb breakfast the first day and a high fat breakfast the second and final day. No drugs administered with this study.

I was also screened and accepted into the EARLY study. The study drug, JNJ-54861911, is in development by Janssen Research & Development for the treatment of Alzheimer’s disease. It acts to inhibit an enzyme that is involved in the production of amyloid-beta (Aβ) fragments in the brain. The treatment period is approximately 41⁄2 years. You need a study partner. You come to the study clinic 28 times in total and submit to cognitive tests, MRI, ECG, lumbar puncture and other procedures. I declined this study due to the following: "In studies of more than 1-month duration, approximately 10% of participants treated with the study drug had abnormalities of liver tests. One study participant treated with the study drug had very abnormal liver tests and a confirmed liver injury...Other adverse events observed with the study drug in studies longer than 1-month include diarrhea (18% of participants at 50 mg dose, 8% at 10 mg dose and 5% on placebo) as well as redness and skin eruptions. One trial that investigated the potential for a heart rhythm disorder demonstrated that doses of 150mg per day have the potential to cause a clinically relevant heart rhythm disorder. Lower daily doses including our highest study dose of 25mg, are not expected to have any relevant effect on the heart rhythm. As a safety measure, ECGs will be monitored throughout the study to identify any potential risks. Based on animal studies in mice, rats, and dogs, additional possible side effects of the study drug in humans might include, but are not limited to, epileptic seizure and lightening of hair and skin."

The 3rd study I was screened and accepted into is the Generation Program, a clinical research study to find out if the medication CAD106 injection and CNP520 tablet (given separately) are safe and have beneficial effects in people who are at elevated risk for the onset of clinical symptoms of Alzheimer’s disease due to their age and genetic status (carrying two copies of a gene called APOE4). It is sponsored by the pharmaceutical company named Novartis (the “Sponsor”) in collaboration with another pharmaceutical company named Amgen and in partnership with the Banner Alzheimer’s Institute, a non-profit healthcare organization all collaborating with the Sponsor in the conduct of the study. You need a study partner. You come to the study site about 4 times per year (a total of 23-26 times over the next 5 years). Procedures include cognitive testing, MRI, PET scan, and others. Side effects and risks such as skin rashes and headaches appear more minor (in my personal opinion) than risks in the EARLY study. I declined this study to to the long distance I would need to travel to the specific site, but may join the same study being planned closer to home.

There is much more information, but this seemed to me the best info to share in a nutshell. I would love to join a study to help science and perhaps be taking a drug that actually prevents or staves off AD! We shall see! I am definitely on the study radar now, having been tested several times and joined a number of registries. such as GeneMatch.

Hope this is of some interest. I do have more data if desired, I did not see any prohibitions for sharing this info, and I am not sure how to attach entire documents.
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Re: Just accepted into an AD Study

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I think it will be interesting to see what happens as the Early Trial enrolls more people. Could be a fluke that one person out of 200 had a liver "injury" that resolved; especially if it was at a higher dose than the current trials. Might be useful if they gave you more info about what kind of injury and at what dose and was that different than the other elevated liver results?

We all want to help find a solution; we just don't want to be charging into the unknown without a good guide!
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Re: Just accepted into an AD Study

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The paperwork I signed for the EARLY study prohibits my participating in any other studies. at the same time, and the study lasts 5 years. Wondering, Rainy, how you can be in two at once.

The Bredesen Protocol people in the Facebook group are all telling me "DON'T TAKE THE DRUG!" I have to ask myself, "Why did you start this journey in the first place?" I started this journey to help other people.

Another bit of vital information I've gleaned from my own research is that the Bredesen Protocol is based on my own WOE. If the BP has any efficacy, shouldn't I be one of those NOT to get AD? After all, I've spent much of my adult life eating what is now called Keto. I do not have the apoE4 gene or any other markers. One would think the BP followers would want to know why. I want to know why.

Looking forward to the appointment for my MRI. That is the tipping point of me and The Study.
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Re: Just accepted into an AD Study

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Hi Reluctantexan,
Like you, I cannot be in another clinical study at the same time as the Generations Study, although the nurse practitioner did advise me that if I chose to enter another study, I could probably do so after a "wash-out" period to have the current drug or placebo out of my system.
Rainy can reply just fine for herself, but I'll chime in. Because she is still in the screening phase of both the Early and Generations program, she's not yet limited to no other studies. The smaller study for Meals and Memory is not an issue that would interfere with the screening process. Neither the Generations nor the Early trial is trying to control for dietary choices of its participants. Might be great if they could track everything I eat, but they're not asking and I'm not telling.
Good luck with your MRI! They may say "great, you passed the MRI with normal results, not let's see you have have amyloid on a PET scan!"

I'm curious about the reasons for the FB group's opposition to the study. FWIW, the nurse practitioner told me that she would have to check, but would probably be fine if I or someone else wanted to follow the protocol. They might need to consider all the blood work required, since the Generations study requires blood work every 13 weeks. They shared results of the typical labs with my doctor, and advised me to up my B-12 levels recently. I assume the EARLY trial would be similarly open to giving you results of blood work that was needed for Bredesen, and working with you to time blood tests so they didn't overwhelm your body.
I know some people have a visceral mistrust of pharmaceutical companies and their profits (which I don't defend). But IF I get colon cancer which, like AD, is in my family, I hope there was a group of people willing to go through colon cancer drug trials to find a treatment that does what lifestyle measures could not--cure my cancer. It's likely that multiple events, some in our control and some not, lead to cancers, AD, Parkinson's etc. Unless we find and study people at risk of those diseases, whether by following those on the Bredesen Protocol or Mediterranean diets, or by trials of amyloid-inhibitors, we won't know what works for which people and why.
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Re: Just accepted into an AD Study

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You know I'm new to this. The only thing I can go by is what is happening to ME. I had to sign my paperwork on the first visit, regarding non-participation in other studies while in The Study. I thought it was the EARLY study, but can find that nowhere in my paperwork. It just says the title is:
A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multi-Center Study Investigating the Efficacy and Safety of JNJ-54861911 in Subjects who are Asymptomatic at Risk for Developing Alzheimer's Dementia.
So I probably have a semantics problem. My bad.
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Re: Just accepted into an AD Study

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The Bredesen Protocol people in the Facebook group are all telling me "DON'T TAKE THE DRUG!" I have to ask myself, "Why did you start this journey in the first place?" I started this journey to help other people.
A belated welcome reluctantexan. Thank you for participating in this trial. I suspect I speak for many when I say that I'm grateful for your service. I suspect the outcry from the Bredesen group was due to the fact that Bace Inhibitors and other anti-amyloid therapies haven't been successful to date. In some cases, they've even worsened cognition. (From what I can tell, cognition hasn't been studied with JNJ-54861911.) I understand that you may be receiving the therapy before symptoms. This is a new aspect of the amyloid hypothesis that hasn't been trialed to date. I'm sending you good energy and hope you find peaceful with your decision. -xo
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