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.