Fourth Monday Susan Speaks

Adventures of the lab rat continue

By Susan C. Price

Alzheimer’s dementia has existed in my family, and in Mike’s. Both of our mothers died of it. My grandmother and my uncle as well (but NOT my aunt). No one has had early onset (before age 75) so it’s not super genetically linked. Who knows what my odds are...maybe 50%. Yet, I fear it. And, because I have yet to find a regular volunteer activity that “fits,” I have started to seek and join in any and all aging and dementia-related studies I can find. I am a lab rat.
    I am registered with several different research units of both the University of Southern California (USC) and the University of California at Los Angeles (UCLA), and a website, ResearchMatch. I am also connected to a number of Alzheimer’s related informational websites. And through those, to various “brain registries.”
    No, I have yet to let anyone drill a hole and my skull and take a sample. No one has offered. And, there probably would be nothing to see. And, if they could see amyloid plaque and tangles, the visible hallmarks of this disease...it still would not tell any of us much, because sometimes folks have all that and no symptoms...and there is no treatment as yet.
    So, I just continue offering my mind and time to take endless tests: “Please count backwards from 100 by 7s,” “Here are three words, I will ask you for them later,” “Can you draw this?,” “Here are 16 words, please repeat them back...now, try that again...and again.”....
    I noticed that the research seemed to be heading in a direction that assumes they might have more luck with drugs having an effect if they focused on helping brains and neurons avoid the plaque and tangles BEFORE there are dementia symptoms, or Mild Cognitive Impairment (MCI) (like...who our age DOESN’T have THAT?!)
    I participated in a study that asked, “How would you react to this study protocol/informed consent form if you were presented with it? Would you do this study?” The researchers said it was for a drug they had and that they were CLOSE to beginning the study. I read about some solanezumab drug. Then, through one of my online registries, I read about an actual clinical trial of this drug, called the A4 Study.

One day the phone rang. The young man, Dr B, asked for me and said he was the Principal Investigator (the PI!!) for the UCLA study related to Alzheimer’s. I excitedly interrupted him and asked if I could tell him all that I knew about the A4 study. He listened and patiently corrected me on one point (they do a PET scan to see if your amyloid plaque levels are high, not a CAT scan...piffle!). As we talked, we both became very excited at the possibility of me being the first in UCLA’s 25 volunteer “allotment” of the 1,000-person international A4 study: a 3-year, double-blind (you might get the placebo) full-on clinical trial of this drug that seems to “scrub” amyloid plaque from the brain without dangerous side effects. The hope is that if the drug does what it seems to, it can hold off or minimize MCI and/or Alzheimer’s. It does not appear to be the “silver bullet,” but this study certainly might advance the science in this area.
    I was so excited when I got off the phone, that I had to talk strongly to myself. “Susan! This is NOT shopping! You can’t just get all excited because the Principal Investigator Himself called you, and he is interested in you. (At my age, any attention can seem flattering and exciting). You can’t just do this because you are flattered! It’s not like buying a pair of shoes that you will later regret. THIS IS SERIOUS!...I calmed down. Some. Then I said, petulantly to myself, “But HE was excited TOO. Not fair to just blame ME!”

In the next few days, the PI, his staff, and I quickly planned for me to start the study. They sent me the 26-page informed consent document. I read it thoroughly and wrote notes in red all over. I read everything I could readily find on the Internet about the drug and studies of it to date. One guy went on at length on his view that focusing on the amyloid plaque was wrong...when I got to his paragraph about mulberry oil...I stopped reading. I do believe that many useful drugs come from “natural” compounds...but I have a bias for Western medicine’s quick and clear and easy fix. (“Fix it NOW” impatience.)
    Then I noticed in the informed consent document that the required “Study Partner” (who is able to observe the volunteer and accurately assess their progress, health, or lack thereof) was supposed to be at the first session we had planned. Mike had agreed to be my study partner. And that scheduled day was Mike’s golf day. A very funny discussion with the PI ensued. He did not seem to understand the nature of a golf day – “Hunh? It takes all day?” Nor that Mike was scheduled to drive someone else to the game and could not, in good conscience, just cancel less than 24 hours before. We finally worked this out. Mike did an hour-long phone interview with the PI the morning of my interview. And I left at 7:30 a.m. – way too early to drive the 3.3 miles to UCLA. (Well, you just NEVER know about the Wilshire Blvd traffic around the 405 freeway and I was unfamiliar with the parking at the UCLA Ronald Reagan Medical Center.) Nervous and excited much?

Dr B and I spent a fun two hours reviewing the informed consent. Yes, this was fun, for both of us. Discussing all the research that led up to this, his feeling that Alzheimer’s research is this era’s AIDS research: important, changing a generation, with false leads and all. And we thoroughly discussed all the possible things that can happen during such a study. This drug has appeared to cause some instances of fluid accumulation on the brain: sometimes there are symptoms with that, sometimes not, and sometimes the fluid just goes away...and sometimes it doesn’t. The study has an optional spinal tap, so they can actually measure the amyloid plaque “leaving” the body. I said (having read up on the process and dangers of spinal tap), “Well, if I’m IN this, I’m IN.” After this first day (which was to include blood and urine tests and some other neurological and medical examinations), the next “barrier” test would be the PET scan. The results of that would determine either that I did NOT have a high level of amyloid plaque (with the therefore increased, but NOT certain, possibility of developing Alzheimer’s...um...not having that level would feel good?) or, that I DID have a high level...that would likely NOT feel so good to hear.
    Then Dr B excused himself as he introduced the psychologist to do some basic memory testing. This time it was, “Count back from 100 by 3s” – MUCH easier. Some of the remembering of more than three words could be challenging. And there was one moment, when faced with a drawing of a wheelchair, that my brain almost refused to bring up the word for the device. About 40 minutes of this stuff. Pleasant and not unfamiliar, after all the testing I have done. The psychologist thanked me and left the room.
    Dr B walked back into the room and sort of looking off into space said, “Well, you are excused now...your memory is way above average for your age...so you don’t fit the protocol.” We were both disappointed. Dr B, his staff, and I had all planned that this would be a full day. We felt...adrift.
    I asked a few more questions to more fully understand the study parameters: they are starting with people as young as 65...but in addition to the high level of amyloid plaque, the volunteers also need to be kind of (I think this is how it works and this is now my own language) more “on the verge” of MCI. With the thinking that…worse memory precedes MCI, which precedes Alzheimer’s, difficulty with daily living...etc. In order for this drug trial to show any meaningful effects, some of the subjects need to move on into that dark demented land...so that hopefully, some of them WONT go “bad” during the three short years of the study, due to the drug removing plaque from the brain. And, it is not certain that this will work. And it would not be a silver bullet. And I was still disappointed not to get to play and be a part of something that might make a difference.
    Funny hunh?
_______________
Copyright © 2014 by Susan C. Price

Comment box is located below