lou-niles

An Army Vet’s 23&Me Test Inspired Him to Join a Clinical Trial. There, He Learned He Had Early Signs of Alzheimer’s

By | February 21st, 2024

After his mother's death from Alzheimer's, retired U.S. Army officer Lou Niles decided to look into his own risk — and to get involved in dementia research. He discusses his inside experience in the clinical trial with Alzheimer's anti-amyloid donanemab.

Biogen and Eisai’s monoclonal antibody drugs for Alzheimer’s — Aduhelm (now off the market) and Leqembi (fully approved by the FDA in 2023) — were the first two of their kind: disease-modifying drugs to slow Alzheimer’s disease by clearing amyloid plaque in the brain. But data is still being gathered on how well these drugs work. While they’ve been shown to clear amyloid plaque from the brain, it’s not clear how much that moves the dial for individual patients. Meanwhile, more of this class of drug are in the development pipeline. The next that is expected to be up for FDA approval is donanemab, which was showed promising results in late 2023 and is currently pending FDA review

Donanemab isn’t yet available to the general public — but it is available to some patients enrolled in its clinical trials. Their experiences may help shed some light on what to expect from these new MAB drugs. Retired U.S. army officer Lou Nile participated in the donanemab clinical trial. Niles served as a combat helicopter pilot in Vietnam and as a firefighter and paramedic in San Diego. When his mother died from Alzheimer’s, he learned he too could be susceptible to cognitive decline, which led him to do a 23&Me DNA test a decade ago. His test results revealed that he had one genetic mutation associated with a higher risk for Alzheimer’s. And when he saw that there was an Alzheimer’s study in Orlando, Florida, where he currently lives, Niles decided to participate.

Over the course of the trial, he discovered that he indeed had cognitive decline and amyloid in his brain. Read or watch the full Being Patient Live Talk with video journalist Mark Nui below to learn about Niles’ experience with cognitive decline and with the donanemab trial. 

Being Patient: How did you even find the trial to take part in it?

Lou Niles: Well, I’ve been searching for an opportunity to deal with Alzheimer’s, and I had the beginning stages that at least I thought I had. I lost the ability to do math like I used to be able to do, and spelling and pronunciation began to fade, and, of course, some memory issues. 

My mother died from Alzheimer’s. So, this is what put me on alert that I probably was carrying the gene. I was tested both by the K2 lab where I participated in the study [and] as I used 23&Me to find out many years ago. They notified me that I had one mutation of the two mutations that put you at risk for Alzheimer’s. 

I came across the study on social media. I think it may have been Facebook. I can’t recall, as I am in an Alzheimer’s study. That happened to be fairly close to me in Orlando, about an hour and a half away. So, I called them up, and they tested me for several other studies associated with Alzheimer’s, but I didn’t meet that criteria. I did meet the criteria to try to eliminate amyloid protein from my brain in search of the correct dosage. 

I’m in the study phase trying to determine the correct dosage, and March will be my year anniversary, where the CT scan, the MRI, and blood analysis will determine whether the stuff worked for me or not. There’s a small percentage of people, of course, where this may not work. 

“I’m in the study phase trying to determine the correct
dosage, and March will be my year anniversary,
where the CT scan, the MRI, and blood analysis
will determine whether the stuff worked for me or not.”

Now, this drug doesn’t fix anything. It merely stops, hopefully, the progression. So, the damage already done— I’m stuck with. That’s where it stands today; at the half-year anniversary analysis, I still have the amyloid protein, and it was not eliminated enough. Now, you don’t get to hear the details of the study as a participant; you just get generalized information, because part of it is very blind. Even the K2 lab employees do not get any detailed information of results. 

Being Patient: ​​How old were you at the start of the trial?

Niles: I would have been 76.

Being Patient: How long had you had cognitive impairment before entering the trial?

Niles: I would say starting in my late 60s. I became more aware of it. What I learned from my mother’s experience is she had it for many years, and nobody noticed. I noticed it one time [when] visiting that the only thing she was eating was avocado sandwiches. She would not fix food anymore. That told me there was something wrong, but even then, I was in a state of ignorance. Then she was later diagnosed. 

“What I learned from my mother’s experience
is she had it for many years, and nobody noticed.”

So, my father was having issues with pancreatic cancer during this really serious determination that my mom had Alzheimer’s, and he died shortly thereafter. This is a horrible disease. She went to my sister’s house in New Mexico. My sister thought she could take care of her. You can’t take care of it. You can’t be a caregiver for this type of disease; it becomes extremely burdensome and difficult. So, she went into a specialized nursing home that handled this disease. That’s where she was until she was about 68. She passed away.

Being Patient: What was it like to submit for the trial? Was it a difficult process to get into the trial?

Niles: No, I have a little bit of a medical background. I was a paramedic firefighter in San Diego, and I also became a naturopathic physician. So, I really am interested in studies, independent of my situation, and I’m always willing to use my body as an experiment. When I heard about the study, there [were] two motives. One is, if I can contribute to the finding of a solution, yeah, let me participate. The second thing is maybe they can do something and arrest this progression. 

The K2 lab that I’m using is full of remarkable people and supportive people. Actually, you build relationships with everybody, and you become friends with everybody. It’s like a visit with friends every time I go there for my IV, and I found it very helpful and very supportive. 

By the way, when you get into these studies, you get several $100,000 worth of studies, MRI, CT scans, bloodwork, EKGs, physicals, all this kind of stuff. They found a left bundle branch block in my heart in one of their analyses with an EKG, which I would have never discovered. They also find other things going on in you besides just this particular aspect of the study because of all the clinical lab work that goes on. That’s a beautiful thing.

Being Patient: Tell us about this particular clinical trial. How often did you have to go, and how much time did the treatment take?

Niles: It’s broken down [into] a couple of phases. The first phase— it was every two weeks. I had to go in for an IV. That was a short-lived phase; then, it went to once a month. Then it’s based on how many weeks, and I can’t recall the details on that, but every so many weeks, you get an MRI: brain MRI, functional MRI.  

“It’s like a visit with friends every time I go
there for my IV, and I found it very
helpful and very supportive.”

Then you get at the halfway mark, you get the CT scan, the bloodwork, and the MRI, to see if there’s any reduction in the amyloid protein in your blood, in your brain. If you fail that particular phase, and you continue on for the next half a year. 

At that milestone, they haven’t said it directly, but if it doesn’t work, my interpretation is if it hasn’t really done that much for me, it’s not going to do that much for me. It’s been very successful in the first several phases of the trial. 

There are people in the study [who] really have obvious Alzheimer’s symptoms, some are severe. I don’t know their status, of course, and I know that we’ve been told over and over again, don’t expect miracles with this because it doesn’t fix the brain if the brain has already been damaged or the nervous system has been damaged. 

That’s what it’s like. It’s really a pleasant experience to have these many people taking care of you. This is particularly important for people [who] don’t have medical healthcare insurance. What a gift.

Being Patient: Did you have any side effects?

Niles: None. No side effects at all for me. My understanding [is that] it’s super rare for side effects to begin with. I cannot remember if I asked if there [were] any serious side effects [for] any of the clients. In the entire world, it’s [a worldwide] study, and I was the first one in the study; by the way, there hasn’t been any serious biological damage done by anybody in the study. 

There was a person who passed away, but there was no correlation with the medication, and you’ll get that issue because you’re dealing with mostly elderly.

Being Patient: So, you chatted with other participants in the study?

Niles: They’re in the room when you’re getting the IV. The IV room has got like 10 chairs. So, other patients will come in; they’ll be sitting next to you and things like that. 

Being Patient: What did you hear about their experiences? Were they very similar to yours? Or were there others that had side effects?

Niles: What’s really weird about that is that no one ever talks about that. I can’t explain that. We sit there and chit-chat about small stuff but don’t really go into our individual cases. Because each person is so different and at different stages. 

You know, it’s not that common people lose their ability to do math or spelling early on. That’s a rather strange symptom for me, and the clinician said that’s not common as well. Memory is usually the first trigger. But people are always suspicious of memory issues, because that comes along with aging. 

The problem I see is people wait too long to be curious. You always have to be curious if something weird happens to you. You’ve got to figure out what’s wrong. Don’t wait for it to deteriorate to the worst degree. 

“In fact, my big fear is if this progresses, and
I reach that stage where I can’t make
decisions for myself.”

In fact, my big fear is if this progresses, and I reach that stage where I can’t make decisions for myself. That line, I don’t know what I would do. I don’t want to go to the advanced stages of Alzheimer’s. There are other resources I can do, if I’m cognitive enough to be able to make decisions for myself. So, I saw a sense of urgency, and because of that, I never wanted to get to that line that my mother went over and was lost forever inside herself.

Being Patient: What do they tell you now in the next step? Will they continue to follow you, and what are some of the follow-up steps?

Nile: There is a separate study by somebody independent of the lab that’s doing follow-up after you leave the study. My understanding is that Lilly itself will not be following the participants’ health from that point on, although there is an organization that is doing that, but I think it’s independent. 

By the way, I want to bring this up too, because some people might wonder if they have to travel great distances and stuff to do this, you are paid. You’re given a stipend for each visit, you’re given mileage, and you’re given $30 a day you visit for lunch, and that’s allowed me to have some sushi. So, that’s a good benefit for me. 

You’re not going to have really a lot of out of pocket expenses. Now if you have to go to a CT scan or an MRI facility separate from the K2 lab, [it] doesn’t do that. My understanding is you don’t get those benefits. At that point, you’re on your own.

Being Patient: It sounds like overall, it was quite a pleasant experience, but you’re not sure whether it had any real effect.

Niles: The only way I’m going to know is when they reveal the CT, MRI, and blood test in March.

Being Patient: What else do you think you learned? In particular, what did you learn about yourself during this experience, and what to keep in mind during the development of these drugs?

Niles: I have a sister who I have pleaded with to get into a study, but she’s in New Mexico, and I think Albuquerque can probably be the closest place. Some people don’t want to know. I have learned through this that you have to be very proactive if you are at risk for this disease. 

As soon as my mother got really bad off, I changed my lifestyle to be supportive of my brain and nervous system. How I eat, what I do, exercise, all this. I was trying to arrest the risk long before there was discussion about medications. 

This was going on in the late 80s when my mother was diagnosed. So, in life, [I] made a big change when I learned that I had one of the genes. My mother was affected, which made me assume I had one of the genes. That’s how proactive you have to be if you really want to tangle with this disease, and you think you’re going to.  Then there are those, of course, that just hope and a prayer and don’t pay any attention to it. 

“Some people don’t want to know. I have
learned through this that you have to be
very proactive if you are at risk for this disease.”

Just, “Life’s life, and I’ll end up that way. That’s the way I’m going to be.” But it’s a horrible, horrible experience, not only for you, because eventually you go into the abyss, and you don’t know who you are or who anyone is around you. Your family is terrorized by this disease, absolutely terrorized.

Being Patient: As you wait for the results of the trial, what are your hopes for the future in terms of this drug?

Niles: The drug, it has been relayed to me, has been effective, and I have a good chance to have cleared my body of the amyloid protein. That’s what I’m hoping on. That’s what they’re hoping on. I will know in March, and that’s my focus. I think I’m going to walk out of this thing better for it.

Being Patient: What would you say to somebody that’s interested in doing a clinical trial?

Niles: Any clinical trial for any disease, if you can get into it, it’s extremely beneficial from a medical perspective. Independent of the actual thing you’re going after, they scrutinize you and analyze you and they will find all kinds of things that, you becoming aware of, you can attend to and get fixed. 

Fortunately for me, my heart disease was not that detrimental; it was very benign, actually — which I find very strange. I was exposed to Agent Orange in Vietnam, so I’m on a short list of all kinds of diseases, including cancer. In my situation, I am particularly vigilant about my health overall because of that. 

I think people have to look at their risk; they have to really look at their zip code, where they live — it really counts about their long term health and longevity. If you live near a freeway or you live near a petrochemical plant, you should be getting checked all the time, for all kinds of things. That’s the thinking I adopted out of fear initially and then curiosity because I’m always curious about everything in medicine. 

I don’t buy into the conspiracy theories about pharmaceutical companies. There are researchers and scientists there that are really, really wanting to do good, independent of the profitability of any kind of medication. This, by the way, probably will be an expensive drug, and since it can be only administered by IV, you’ll have to go to an IV center. I don’t know what those costs are, because I’m getting everything for free. 

Katy Koop is a writer and theater artist based in Raleigh, NC.

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