5. Trial

I have mentioned in a previous post or two that I was exploring (and finally accepted into) clinical trials. Because I was approved for Leqembi, I did not pursue any medication trials, although there is a lot of really interesting stuff happening on that front. Back when Wendy was exploring (and eventually participating in several) trials, she had a doctor who advised her that taking a known drug was far better than taking an experimental one - and if you had to go off a good drug to try the unknown, it wasn’t worth it. That makes complete sense. The thing about trials is that you often never know your results, or if it’s helped. In many cases the trial team is forbidden to tell you. An example of that is that Wendy was in a stage 3 trial (that’s the last trial before approval is possible) that really helped her. We knew she was on the drug because of the positive effects it was having on her blood levels. We weren't allowed to see the results of the copious blood draws at her appointments but she could get blood drawn elsewhere, via her PCP, and compare data. There were some side effects as well, to be sure. But the thing is, we don’t know what drug it was. It could be on the market now, and we just aren’t aware. The reason to do clinical trials has to be for the greater good. You must be altruistic, and be in it for the long game. It’s very difficult to know that even if the trial drug works for you amazingly, you will be off of it at the end of your trial, and it might not make it to market for years, or even ever. You could die (depending on the illness) knowing that a cure (or slow down) is there, but you can’t get it. Sometimes (as was the case in one of Wendy’s trials) from a purely financial standpoint. This drug (unknown) was on the market for some other reason, and they were testing it for Wendy’s illness. It worked! But at close of trial, the pharma-bros decided that there wasn't enough money in it to market it towards the rather limited number of people that are afflicted with her disease, so they tabled the whole shebang. I believe I mentioned in another post that the medical system in this country is screwed beyond measure! Letting money be the driver in a process that is supposed to help people is corrupt in so many moral and ethical ways. That drug worked! And it was already FDA approved for something else. But Wendy does not have the proper diagnosis to get it.  And nor would we know what to ask for.

The study that caught my eye (and actually really excited me) is out of Northeastern University in Boston - about 2 hours (on a good day) away. It’s being done by the Music, Imaging, and Neural Dynamics Laboratory (MIND) and is investigating the effects of music and multisensory stimulation on brain activity in adults who are experiencing memory loss. Right up my alley, right? So here’s how it works…

Over the phone, I was given a short neuropsych exam. Pretty much the standard. Remember these five words, where are you? What’s the date? Etcetera. Clearly I failed enough to be accepted into the study. Then they asked , via email, to name my six favorite songs. Well, I can’t do that! (It has no relation to my ALZ, I just don’t have favorite songs. It’s not the way I listen. I know it’s semantics, but I felt I needed to be clear that if they asked me the same question the next day (or week, or even later that day), I might give a different answer. In any event, I ended up picking the following:

Miles Davis - Right Off (from "A Tribute To Jack Johnson")

All Them Witches - Blood and Sand / Milk and Endless Waters (from "Live On The Internet")

Van Der Graaf Generator - La Rossa (from "Still Life")

Tedeschi Trucks Band - Midnight In Harlem (Swamp Raga Intro With Little Martha) (From "Everybody's Talking")

Cinematic Orchestra - To Build A Home (From "Ma Fleur")

Dhafer Youssef - Odd Poetry (from "Divine Shadows")

I look at that list now, and think why the heck did I pick that one? But that’s what I came up with at the time. Not a stinker in the bunch, but (for the most part) pretty far from my favorite songs currently. I’d actually knock only the Miles off the list right away. (See how my brain works? I’m stressing about this freaking list because it’s not RIGHT!!!) That’s really how important music is to me, that I can’t make this basic stuff that normal people do happen. Again, this would be a conundrum even if I weren't suffering from the ALZ. We’ll revisit this concept in later posts!

The initial visit with the MIND team was on a Thursday at 9AM. Pretty stupid time to be driving into Boston. The two hour drive took nearly three. I really don’t know how people live like that. But that’s the way it was. Next time, I’ll probably leave early and sit and have a coffee or something. Or stay in Boston overnight. The day, all eight hours of it, went like this: \

After a little confusion, we found the folks running the show, and they ushered us to the basement of the bustling Life Sciences Building. The first step was introductions, and then I began to fill out a long survey on Google Forms. The survey asked the standard cognitive questions about depression, anxiety, feelings of worth and more. It also asked detailed questions about my relationship with music. Had I studied (yes), for how long (since I was a kid), what did I play (guitar, bass, saxophone), could I read music (not any more), did I have a good ear (yes), did I have a stereo (not really - all my stuff is digitized, and I have very good computer speakers), a collection of music (yup), go to concerts (yes), feel better when music was on (yes, if I like it), and more. By this time, Wendy had taken off to go see a friend. The next test was The (I thought of it as) Walk and Chew Gum test. I had to walk the length of the hallway at a quickish pace. Then I had to do it counting backwards from three (starting at a random number). This was repeated in several iterations and formats.

Then they took me upstairs to do a blood draw. Now, I have finicky veins. They’re rollers. Phlebotomists have had issues with my inner elbow for quite some time. I’ve been in for a simple blood draw that has taken the efforts of three different people to work. I’ve been needled two or three times, on multiple sites. So I know my veins and how they work. Yet, in general, the lab techs rarely listen to my advice on where it works, and stab away. So, here I made an error. As I sat in the chair, I told the young woman that everybody struggled with my inner elbows. Lots of phlebotomists failed to get a draw on the first (or even second) attempt, and I suggested that she use my forearm - which is where I get my infusions, and seems easy to access, or even my hand. When she replied that she wasn’t allowed to go anywhere but my elbow, I realized she was a student - and I had made her nervous. I always try to have a sense of humor about this, and despite the fact that often blood draws hurt because of the repeated attempts (and the excess band-aids hurt when pulling off my hairy arms), I approach this in a joking manner. Unfortunately this also failed to soothe her. It took her three attempts, with multiple approaches, but she got it! And I told her she was great! I have no idea what they were looking for in the blood, and never will.

After that I went down to the MRI facility. I was in the MRI tube for over an hour while they continuously took images of my brain. They also had a screen that I could see, and a four clicker remote. They ran a steady stream (ten seconds each) of pictures of random faces that all had names. Then they showed me several faces (all of which I had seen) with two name choices to pick from. Using the clicker - left thumb for 1, right thumb for 2. After that was over, the music came on. Twenty seconds of music, and four choices - I know this, I don’t know this, I like this, I don’t like this. The main problem with this process was that most of the music sounded like AI generated clarinet playing random tunes. Interspersed with the six songs I had picked earlier. I think that it would have been a lot more interesting (and probably informative) had they used real tunes, no matter their nature. Because I couldn’t “like” any of the AI stuff, and I barely knew it. I think I recognized a couple of instances of familiarity, but I didn’t know for sure. All this happened while the MRI machine was whirring and clanking away. I would LOVE to see those images!

Following that, I went to the lobby for Lunch. Wendy was back, so we sat outside while I ate a pretty good Cuban sandwich. She had seen an old friend and went to a museum, so her day had not been completely without merit. I then went back downstairs for the rest of the session. I was given an EEG helmet:

Each one of the nodes on the helmet had to be filled with conductive gel (like a sonogram). Before long it was oozing down my head. (When I got home later, I saw that it had crusted all over the arms of my glasses.) Eventually, they got a signal. The purpose of the EEG was to see how my brain reacted to music they played while I was watching a light show. They did not ask me for my choice of music. The first song played is probably one of my least favorite songs, from one of my least favorite albums by one of my least favorite artists. In fact I hate this album so much, that it has tempered my enjoyment of much of his earlier collaborative work, which is actually really good. That’s the way I’m wired. I’m speaking, of course, about the title song on the album Graceland by Paul Simon. I’m not sure if they got the reading they were looking for! That was followed by Under The Boardwalk by The Drifters. A perfectly sensible and appropriate choice. No problems. They changed the light settings a bit, and then played the same two songs over again (but in reverse… Not the songs, the order. I might have preferred Graceland in reverse though.) And that was it for lights, which I had thought were going to be a major component of the day. 

Finally I had a long written and aural cognitive test. It was extremely well done, with lots of different components thrown in randomly, including deep off topic dives. All in order to occupy my mind and see what came out on the other side! For example, one of the test items was to listen to the examiner tell a story, and try to repeat the story back in your own words, but hitting as many salient points as possible. Great! And then there was a long “repeat the number string back” (which I did surprisingly well on considering that numbers are a real weak point for me in real life). Oh, and then “what was that story I told you?” And after it was all over, and I was getting ready to get up, at least an hour later, “tell the story one more time!” Very interesting stuff. I wish I could know how I did. Maybe they’ll tell me after the entire process is done, which is eight weeks from start to finish.

I was sent home with a light kit and homework. I had to create a Spotify playlist. Actually two of them. One called Energetic, and one called Relaxing. They are linked below in case you want to check them out:

Relaxing:

Energetic:

I have to listen for at least a half hour a day while looking at the light.

It works way better in total darkness. I get up super early these days, so I generally do the energetic list in the AM while it’s still dark, or I do the relaxing list after dark just before bed. I am, much to the chagrin of the examiners, consistently changing the playlist - adding new things as I think of them, and removing ones that I don’t really want to occupy myself with after a listen or two. I listen on random. Spotify does not keep track of what you’ve heard if you navigate off the list, so there are a lot of repeats, despite my lists both being well over six hours long. (They asked for an hour and a half!) Each week I get a call asking how things are going, and each week they ask me if there are any changes to the playlists (which they have access to). Each week I say, almost verbatim,  “Dude! I’m consistently changing the lists. I think the one thing you don’t have to worry about is my list management!”

I’m in the middle of week four of this now, and then I go back for a repeat of the entire eight hour day. In just over two weeks, I’m flying to Phoenix to visit Jonas and Pickles. I have to figure out how to safely pack the light. It is two feet tall, and barely fits in a suitcase. I’ll make it work though!

Here is a link to the study itself, and contact info in case you are interested in joining up. https://clinicaltrials.gov/study/NCT05984524 If you have or know anyone experiencing any cognitive decline, it’s worth a try. It may help you/them directly, or it may be for the greater good someday. The more data we can get about this awful malady the better. Perhaps together we can Kick Alzheimer’s To The Curb!!

Finally, this week I had my mandated MRI - Different from the one in the trial. This is required when one is taking Leqembi due to the 1-150 chance of brain hemorrhage. I’ve not yet met with my Neurologist to go over the results but I have seen them in my chart. No bleeds! Yay! I think I have to do three more MRIs during the initial course of treatment. I’m happy to be involved in such a thorough program, working with conscientious people. And of course, thankful that - despite some initial shenanigans - my insurance is covering the entire process. I just read that the NHS in the UK has elected not to cover this treatment at all, which is terrible. Medicare, here in the US, does cover the process, so let’s (again) vote like our lives (and mine) depend on it. Every 67 seconds, someone in America develops Alzheimer's. It is estimated that nearly 500,000 new cases of Alzheimer's disease will be diagnosed this year. Let’s be sure we can always get affordable treatment, and that the pharmaceutical companies will continue to research new and better options.

Thanks for reading,

Sean