jkramer65 wrote:I'm not sure if this is the right place in the forums to post but wanted to get some feedback on a consideration I'm debating to participate in a clinical trial. For reference it is this one: NCT03663387. It is measuring CSF clearance of amyloid and tau from the brain using PET with tracers not approved by the FDA. One tracer has been used for 10 years with no issues and the other (for the tau part of the testing) is fairly new so there isn't a ton of data on side effects/dangers etc. That concerns me a little. As well as 4-6 MRI/CT/PET types of scans in a 2 year period. It is run by a doc well known in this field. supposedly considered a pioneer. Dr. Mony de Leon at NYU. Anyone ever heard of him?
I want to help with prevention since i'm a pretty good genetic sample for risk but I am also being selfish and want to get a free MRI of my brain for a baseline and possibly be able to get the results from the amyloid PET to see if plaques are building up. I also would be interested in officially being neuro and memory tested vs. doing my own self evals...
I would appreciate any opinions.
Thanks for listening and sorry if this should have been posted somewhere else on the site.
You can post wherever you want on this site! Posting in "Our Stories" was a great choice for your question, because nothing is more personal than making a decision about your own health. As someone who is also in a clinical trial (Generations I), it is NOT a selfish decision to hope you get some results and benefit from this; simply informed self-interest. Each study makes its own decision about what to share and is very clear in the lead-up to actually starting with detailed verbal and written consent forms. In Generations, I have been able to get the results of blood tests, and general info about my MRI, but do not get the results of the PET scans about amyloid, or the results of the cognitive tests.
Having given a lot of tests to kids over the years, I do remind myself that they are not like spelling tests. The goal is not to get 100; they are designed to keep going until you reach a "ceiling" cut-off. So never feel that you didn't do a good job on one of those when it gets hard.
As for Dr. de Leon, he is a long-established researcher, per the quote from the NYU website below. The fact that he has been in the top 5% of grant funding recipients for the National Institute of Health (NIH) for the last 25 years indicates that he has consistently demonstrated the ability to lead multi-year, competitively funded projects related to NIH targets for research and achieved results that advanced knowledge in the field. I recently attended a session to review funding through the Dept. of Defense for Alzheimer's funding as a "consumer reviewer' and learned that getting funding through the NIH is a mark of researchers who are viewed as having outstanding research approaches, methodologies, and personnel appropriate to the task. (The same is true for the DOD, I think!)
https://med.nyu.edu/adc/researchers/aff ... ny-de-leon
Dr. de Leon is the founder and director of the Center for Brain Health in the Department of Psychiatry, NYU Langone Medical Center. Dr. de Leon and his team wrote many 'first' papers, including: the now well established early hippocampal atrophy and glucose metabolism alterations in Alzheimer disease, as well as the first longitudinal imaging reports to predict the transition from normal aging to Alzheimer's dementia. Dr. de Leon has remained in the top 5% funding tier of the NIH for the past 25 years. In 2009 at the centennial celebration of the birth of Alois Alzheimer, Dr. de Leon was elected as “The world's pioneer in the brain imaging of Alzheimer's disease".
If you haven't seen it, this is a helpful link from the Clinical Trials website: Learn About Clinical Studies
. It includes info about protection for participants and questions to ask.
As for myself, I will have about the same number of MRI scans as you and about 3 PET scans over the course of 5 years. The consent form I received gave information about what this was the equivalent of in exposure to radiation. I decided that it was worth it to risk what I viewed as a minor, future risk of that against the much more real risk of MCI and dementia to perhaps help myself and advance the research in the field.
My lay person's understanding of the interest in cerebral spinal fluid (CSF) clearance of amyloid and tau is that it could open up a whole new field of intervention. Amyloid and tau have been thought to be problems of too much production, so the target of that is to go "upstream" of production and reduce it. The study I am on seeks to do that with a BACE-I inhibitor of amyloid beta.
But recent discoveries of a glymphatic clearance system in the brain, and of differences in the amount of amyloid and tau in the brain and the spinal fluid, have led scientists to think that it could be a clearance problem, not a production problem. The best way to measure that is to compare differences between PET scans and CSF lumbar punctures (LPs). Although I haven't had LPs in my trial, I have been assured that they are painless nowadays, and did have two epidurals during C-sections years ago that were painless.
You can always back out of participation at any point in the screening process, and during the trial. Do what feels right to you, and let us know what you discover!
One final thought on your sister's diagnosis and the understandable emotion of being "scared to death". I don't know my three sibling's ApoE status--nor do they, I believe. Yet the sister who is most similar to me physically has had serious life-long mental health issues and hoarding, which I have avoided. The one who is most like my paternal grandmother in appearance and personality also has some of the health issues my mother had. So appearance doesn't equal genetic make-up. It's entirely possible that your middle sister, even if she is also 4/4, had other genetic, environmental and lifestyle factors that increased her risk. We are all lovely quilts, composed of the colorful assortment of genes, epigenetic triggers that turn those genes on and off, our own environment and experiences. Trust that with a 12 year difference in age, you likely share only 50% of your sister's genes and far less of her life experiences. And look forward to being like your long-lived mother and father!!
Hugs from a 66 year-old ApoE 4/4, "older sister"!