Thursday, August 5, 2021

Medical Studies – Giving Back – An Update

Back in December 2019 I posted about the various medical studies that I was participating in (see here for details). But things have changed since then and I thought it was about time for me to post an update.

C-diff Study

I began participating in this study in the beginning of 2018 following my hospitalization for sepsis. This study involved getting three injections of either a vaccine or a placebo (saline solution) and then being followed for three years to see if contracted C-diff. I checked in monthly on an electronic diary. The study was supposed to last until September 2020. However, as that date was approaching those running the study extended it for another year until September 2021 (I think because it took so long to recruit the 17,000 people in the study that they needed the later participants to finish their three-year participation). But as my three years had been reached, they asked me to return my electronic diary. I’m not sure if I will find out if I was given the vaccine or the placebo after the study ends next month, but at this point I don’t suppose it really matters.

Alzheimer’s Study #1 – Aging Brain Cohort

As I noted in the above posting, I’ve been participating in the ABC study since the fall of 2019. This test involves a physical and mental evaluation, a brain MRI, a PET scan and/or a lumbar puncture. The evaluation is repeated every year. They also ask you to consider donating your brain when you pass away.

In November of 2019, I had the lumbar puncture. After posting about it, I was interviewed by the Penn Memory Center and they featured me in their monthly newsletter! You can read the article and see pictures of me and my family here.

When COVID hit in 2020, the schedule for participation was significantly impacted. The annual evaluation was conducted remotely and some portions that could not be done that way were eliminated. However, as COVID restrictions relaxed this spring, I was able to travel down to Philadelphia for my brain MRI. Lying still inside the machine for over an hour was an interesting experience. But before I left the lab, I was able to see some of the images. I can now confirm that my brain cavity is NOT empty and there really is something in there!

I have also now signed the paperwork for donating my brain (now that I know that it’s actually in there!). I had agreed to take the PET scan this fall, but that is now on hold due to my pending participation in the AHEAD study (see more on this below).

Alzheimer’s Study #2 – APT Webstudy

In March 2020, I was informed about the availability of a new study called the Alzheimer Prevention Trials (APT) Webstudy. This is purely on online study that is aimed at developing a large online group of individuals who may be at higher risk for developing Alzheimer’s dementia, and who will allow their memory and thinking test results to be tracked over time. This study is not very time consuming and consists of signing on to an application every three months for about an hour or so. They give you a series of “tests” designed to stretch your memory and thinking skills and see if they change over time. The tests are all playing card based and require you to answer yes/no as quickly as you can. Tests include responding yes when they flip over a red card and no when they flip over a black card; responding yes when the card flipped over is the same as the last one and no when it is not the same; responding yes when you have seen that card before in the test and no when you have not seen it. This latter one is especially challenging as the number of cards you have to remember gets higher and higher as the test progresses!

My scores have remained nearly similar over the past year+ which is a good indication that my thinking/memory skills are not yet impacted.

Alzheimer’s Study #3 – Memory and decision-making

Last month I was contacted about another study – a one-time commitment of only 2 hours. I initially declined as it would have required travel to Philadelphia. But then they offered to have me participate via a remote link so I agreed. In this test you learn about decisions made by other people and then make decisions of your own. It’s looking for how other people’s opinions influence our own decision making (the concern being that when people find out if they or a family member has dementia how does that influence them). My participation is scheduled for later this month, so I can’t comment much more at this time, but I’m looking forward to it.

Alzheimer’s Study #4 – AHEAD

Because of my involvement in the APT Webstudy (#2 above), back in January I was contacted by one of the clinical research coordinators at UPenn asking if I would be interested in participation in a study called TRC-PAD (Trial Ready Cohort for the Prevention of Alzheimer’s Dementia). This study if for individuals over 50 who may be at increased risk and is to develop a pool of individuals who can get prescreened and are thus ready when drug studies are initiated. Since these are not just tests, but would involve receiving actual injections of trial drugs (much like the C-Diff study above), it was not something that I took lightly and so my wife and I had to have a more serious discussion about it.

As the research coordinator and I had several back-and-forth emails over the following months, we (my wife and I) agreed to my participation. But meanwhile, a study was being kicked off for which they would be looking for participants and I could just skip the TRC-PAD and move directly into this new study. It was known as AHEAD (see https://www.aheadstudy.org/ for more details). None of the initial participants in TRC-PAD had been interested in this study, so this was definitely new ground for me.

The drug being studied is designed to remove/eliminate the amyloid plaques in the brain before people have symptoms of Alzheimer’s. This is a phase three study, meaning the safety of the drug has already been evaluated. There is an initial PET scan to determine what level of amyloid plaque I already have. Depending on the level It requires either (1) bi-weekly IV injections every two weeks for the first two years and then every four weeks for another two years or (2) monthly IV injections for the full four years. The commitment of having to drive to Philly that often was a bit more than I was willing to take on, but they are working on having a home infusion service (having a nurse visit) and with that change I was willing to participate.

We are still working at setting things up for this. I will still have several trips to Philly at the beginning – for a PET scan as well as blood work and the first few IV sessions, but that’s reasonable. As I mentioned above in #1, this AHEAD study will supersede the ABC study and so we have put the PET scan needed for that on hold pending getting everything set up for this new, much more intense, study.

Summary

As I mentioned in my earlier posting, I am committed to participation in these Alzheimer’s studies because of the dementia in my own family (my father and his mother). I have also seen the impact of it on people like Dr. Cook (our former family doctor and a member of our church) and others in my family as well as our church family. This AHEAD study is going to be taking things to another level with getting at least monthly IV injections for four years. But I still feel the same way that the opportunity to help others in the future is something that more people should consider.

When I mentioned this to our current family doctor last year, she was also impacted by my commitment – so much so that she also signed up to participate in a study related to an autoimmune condition which she suffers from. Usually, it’s the doctor giving advice to patients, so when she later told me how I had influenced her to do the same I was surprised. One never knows what influence one has.

Have you ever considered participating in a medical study? If not, why not!

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