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Re: CAD106 and CNP520

Posted: Sun Apr 30, 2017 1:46 pm
by Mardi
Article from the Wall Street Journal on Novartis Clinical Trials for CAD106 and CNP520


CAD106 is designed to boost the immune system's ability to clear beta amyloid from the blood.

CNP520 (developed with Amgen) aims to stop its formation in the first place.

The Banner Alzheimer's Institute is helping Novartis find eligible participants. They are looking for individuals with 2 copies of the gene APOE4 between the ages of 60 to 75.

There are at least 4 of us from this forum participating so if you have questions ask.

Re: CAD106 and CNP520

Posted: Thu Jun 08, 2017 7:26 pm
by Mardi
Just checking in to see if there are any more participants in the CAD 106 and/or CNP520 clinical trial? There are several of us already enrolled or in the screening process.

This is also referred to as the API Generation Study. Let us know how you are doing or if you have questions ... 106&rank=5

Banner Alzheimer's Institute
National Institute on Aging (NIA)
Alzheimer's Association

Re: CAD106 and CNP520

Posted: Fri Jun 16, 2017 5:05 pm
by lol
Yes. Please let us know if you are interested in the Generations Study. We keep in touch and support one another.
I have now had my 4th injection, and am doing okay!

Re: CAD106 and CNP520

Posted: Mon Jun 19, 2017 5:34 am
by lol
Thanks to this website, I have found Study Buddies who are compassionate, supportive, and understanding of my venting.
Thought I should be in touch with other 4/4s after big visits. The following is a copy/paste that I sent out to my buds:

I survived Wed, and it wasn't that bad. It was well organized and I got prodded and poked and cognitively tested for about 5 1/2 hours. The cognitive tests are pretty much the same every time, and I kind of like them. Of course, we will improve because we understand the tests better. I did okay. Actually better than okay. Brag brag.

I followed your advice, dear NF52, and pretty much demanded to see the doctor in charge of the Generations Study at Penn (with minor complaints). I wrote down and practiced what I was going to say to him. Am I a dork, or what??? I spoke my mind and he listened. Then he said to contact him whenever I wanted. I fired back - when I call, I just get forwarded, forwarded, forwarded, forwarded. I have gone from meek to a bit aggressive. It was such a long day and my patience just ran out. Blood draws, EKG, MRI, neurological exam, physical exam, urine test, vitals over and over, injection, physical exam, suicide testing, testing on my feelings for the past 7 days, and testing to compare answers with my husband. My husband is the real dork here. Good thing I love him! We were asked to discuss a major event that had occurred in the last 2 weeks. I named the death of a friend, trips to the hospital to visit a friend with pneumonia, going to a viewing for the death of my friend's brother, my daughter in emergency for 6 hours for a choking incident. Do you know what he said?? He was in the money in a golf tournament. You have to laugh. Even the tester started laughing. She asked him if I had also played. "Yes. She played, but didn't do very well. Wasn't in the money." :lol: The study partner idea is not working out for us. I even prompted him on the way down to Penn as to what to say. Oh well.

My blood pressure is fine now, and I wasn't sick today. Just so tired. My guess is that I have the CAD106, not the placebo.

Wanted to mention that the study doctor at Penn told me that he was very involved with the implementation and decision making of the Generations Study. He also said that Penn would never accept a trial unless it was very "promising". Good news.

Better news? I don't have to go back to Penn for 4 months. Yeah!

Re: CAD106 and CNP520

Posted: Mon Jun 19, 2017 7:22 am
by SusanJ
Thanks for the update, lol. Good for you, my friend, for getting assertive!

And thanks for the story about your hubs. A good laugh to start my day. :lol:

Re: CAD106 and CNP520

Posted: Wed Nov 29, 2017 6:59 am
by DDorans
Hello I did Gene Match and am Apoe4/4. Am still dealing with this news but trying to be positive and continue on with my life. Am trying to decide if I am going to participate in the study. I did talk to the study doctor at length but still have more questions that I will need answered. Not sure my husband can take the time to be a study partner. They said it would be 1 visit and then could be over the phone. Did I read that the drug could possibly make cognition worse. It was nice to find this website. It’s so informative and I don’t feel so alone with the news.

Re: CAD106 and CNP520

Posted: Wed Nov 29, 2017 10:38 am
by Jan
lol, your participation is inspiring, and I look forward to updates. :-)

Re: CAD106 and CNP520

Posted: Wed Nov 29, 2017 10:55 am
by Jan
Welcome, DDorans, so glad you found our site. You are definitely not alone. It certainly takes time to process news such as you received, but that you are continuing to be positive and get on with life is excellent. The best way to handle it.

Since you are new to the site, I want to point out our site Primer: viewtopic.php?f=33&t=1418 It was written by physician member Stavia, and will no doubt answer many of the questions which have arisen since you received the news. The Primer is very straightforward, and clearly marks "settled" science from topics still being debated. You'll find on the site that we have members from various perspectives. We encourage sharing what's working for you.

I'm not familiar with the details of the study, so can't speak to possible negative effects. (Hoping others more aware will be able to chime in.)

We'd love for you to tell us a little more about yourself. Click Board Index (top left of page), Our Stories, then New Topic to post an introduction. And feel free to post any additional questions you have. We're here to share information with you.

Re: CAD106 and CNP520

Posted: Thu Nov 30, 2017 6:49 pm
by NF52
Hi DDorans!

A warm welcome!

I know the feeling you spoke of:
DDorans wrote:Am trying to decide if I am going to participate in the study. I did talk to the study doctor at length but still have more questions that I will need answered. Not sure my husband can take the time to be a study partner. They said it would be 1 visit and then could be over the phone. Did I read that the drug could possibly make cognition worse. It was nice to find this website. It’s so informative and I don’t feel so alone with the news.

I too am an ApoE4/4, learned it accidentally 3 years ago from 23 & me and like many people here, was shocked and horrified. I think the first article I read stated as a fact that I would get an Alzheimer's diagnosis likely by age 68 and had a 9-12x average lifetime chance of dementia. (What did that even mean?! "9-12x" what number? Was the likelihood 100%? I'm now 65 and still going strong by the way.) After reading lots of articles through Google Scholar, often with the search on "healthy elderly ApoE4", I found out that the most recent (March 2017) meta-analysis of 4 large studies in the U.S and Europe suggests that the five year risk at age 65 is very low, and that the lifetime risk to age 85 is both highly variable (meaning that ApoE 4/4 is not destiny) but probably between 30% and less that 60%. I view that as positive news, and decided to both enjoy life, my family, travel-- and to search for clinical trials.

Right now, I am in the third month of being on CNP520, with a 60% chance that I have the drug and a 40% chance that I am taking a cute red pill that does nothing. I'd be glad to answer questions, not as a scientist, but as a participant, either online or through private message. You can go to the upper right of the page and click on the envelope to send a private message, although it may be that you have to post at least 2 more times to do that.

But here's a go at answering some basic questions:

First, your husband might be the logical choice as your "study partner", since he can answer questions about your daily functioning and also serves as a check on your memory. (Although even husbands don't share all of our memories! My own husband and I have complementary memories: mine is great for dates and projects, his is good for names, faces and movies. So I can tell you that today is my sister-in-law's birthday; he told me today how Geraldo Rivera became famous in the early 1970's as a journalist--around the time it turns out he was harassing Bette Midler! To each his/her own.) The good news for your husband is that he doesn't need to come to every appointment for this study. During the screening process of 2-3 months, he'll come for an initial meeting, where both of you will have a detailed explanation of the study and have the chance to have any questions answered before signing (if you're ready) consent forms. Then he'll come for some follow-up testing roughly every 6 months, for those questions on daily living skills and memory of a few things what you've done together in the recent past. (We shared that we had seen the movie Dunkirk together the previous week.)
My husband and I are retired, but I know of two women whose husbands are working but are able to take the half-day or so every six months without a problem. But if your husband isn't able or willing to be your study partner, it may be feasible to have a good friend in that role. I know of someone who is doing just that, as she has been single for a long time and has a group of close friends who have known her for decades.

As far as the study drugs worsening your cognition, I have seen NO evidence of that, and believe me, I've read the studies showing the early trials with people. (This is a Stage II/II clinical trial, which means that CAD106 and CNP520 have already passed review by the FDA for initial safety and efficacy. Doesn't mean there are no side effects, or that side effects couldn't show up when these drugs are taken for a period of 5 years or more. But the evidence so far is that they are safe, and the study staff and consent forms are clear that they will let you know if at any point they think that you individually might be harmed by continuing (which could be from a medical condition unrelated to the drug). And they have outside evaluators who monitor the safety of the drug. That's why some other Alzheimer drug trials have been halted early: because it was determined either that a small group of people were having serious side effects, or because the drugs had not shown any benefit and there was no point continuing the trial.

The screening process involves a repeated cheek swab (to be sure you are really ApoE4/4), blood and urine tests, an EKG (to be sure you're heart is healthy), an MRI (to rule out significant brain anomalies that would prevent you from being in the study), a PET scan to determine whether you have amyloid protein in your brain. It's not a pass/fail issue; I assume I have some, but they won't tell you the results. (I actually found the PET scan to be like a weird spa treatment: like quietly for 30 minutes in a darkened room while an IV travels through you, then lie quietly listening to music for 20 minutes in a pretty quiet machine.) You also have cognitive testing of memory, thinking, visual and auditory skills. Nothing to study for; some of it's simple and some of it's designed to keep getting harder until you fail. Nothing that you're expected to be perfect on. It's really just a baseline, to see how people change over the five year period. The researchers hope that people on either CAD106 (a shot) or CNP520 (a pill) show fewer changes in their performance over time.

I have found the study coordinator and nurse practitioner I see at my visits to be warm, honest, and trustworthy people. I also met the doctor in charge of the study, but my contacts for visits are the people who do the tests and answer most of my questions. I really value my ability to be in this study, even though I know many people have qualms about Big Pharma. The fact that the National Institute of Health has contributed $33 million to it, and that multiple universities have signed onto this in the U.S. and abroad, impressed me. (And Dr. Pierre Tariot, who is one of the leaders of this study, is someone I knew of 30 years ago as determined to help those with Alzheimer's, as a clinician, researcher and relative of a someone with Alzheimer's.

It helps to think that I may be doing something to benefit my children, who are all 3/4's and in their 20's and 30's, even if it's only to close off this avenue of approach. And in doing this study and reading this thread, I also "met" 3 other women who are in the study. We have become sources of support and laughter through this process, and hope to share that support with others who may be interested. None of us are wimps in the "Asking questions" department, so we would all applaud you asking lots of questions at any point.

Hugs from Virginia.

Re: CAD106 and CNP520

Posted: Fri Dec 01, 2017 11:36 am
by lol
Big Pharma" takes a big hit, frequently on this website. The pharmaceutical companies are businesses, like other businesses. Their goal is to make money, and you need a good product to make money. You hear a lot about the unfair expense of offered drugs, but with increased competition and generic pharmaceuticals, the price can dramatically drop. My generic statin is cheap. The pharmaceutical companies give a lot of people jobs, and have saved many lives. Unfortunately, scientists and doctors fail over and over in trying to find drugs to cure/help. It is a process that I am a part of. The process of finding a cure for AD has taken and probably will take years of trials and studies. Many failures are part of the process. With every failure, something can be learned. As a part of the Generation Study, I am offering scientists a chance to learn just a little more. Maybe offering the CAD106 or CNP520 before the onslaught of the disease is a good approach to delay. I think so. Actually, my cognitive skills have increased since my injections have started. While I do not necessarily believe that this study will provide a cure, it might buy me some more time. I feel at peace in helping future generations on the path to finding a cure.

I understand that many here believe in a more natural approach to beating out our AD odds, through fasting, dieting experimentation, supplements. That's all good. We are all different.

Thank you, NF52, for your post. As she mentioned, the 4 of us here in the Generations Study have become close and supportive friends. We have met and have a wonderful bond. These 3 women are very intelligent, have had amazing careers, and are kind. We can offer you support if you choose to be part of this study, DDorans.