lou-niles

Pros and Cons: 4 Patients Open Up About Participating in Alzheimer’s Clinical Trials

By | July 10th, 2024

Four clinical trial participants share what they gained from participating in clinical trials for Alzheimer's treatments like the newly approved Kisunla — the good and the bad.

It can be challenging to find information about Alzheimer’s clinical trials, let alone find trial participants’ first-hand accounts of their experiences. People living with Alzheimer’s or dementia might be unsure of the risks associated with participating and the potential benefits they may receive to their health.

Beyond a lack of information provided by trial centers and pharmaceutical companies to the general public, there have been even less outreach efforts in communities of color, resulting in staggering disparities in levels of representation of people of color in clinical research. Food and Drug Administration data shows that as of 2020, 75 percent of trial participants were white, while just 11 percent were Hispanic, 8 percent were Black, and 6 percent were Asian.

Clinical trials can carry risk, as the therapeutics being tested are not FDA-approved yet. Tests in humans is a critical part of that journey. Bill Sasse, who participated in Eli Lilly’s solanezumab trial, offered advice for anyone interested in participating: “Do your own research,” he said — talk to your doctor and know the risks involved before you register to participate in a clinical trial.

Learn more:
Six Things You Should
Know Before Enrolling
in a Clinical Trial

To demystify a process that has been criticized for giving little educational information to the public, four clinical trial participants share what they gained from participating in a trial, and where the studies fell short.

Here are four stories from the trial participants in the Being Patient community about trial participation.

Lou Niles: A lifesaving medical discovery

After his mother died of Alzheimer’s, retired U.S. Army officer Lou Niles decided to look into his genetic risk of Alzheimer’s with an at-home 23&Me test. The results revealed Niles had one genetic mutation associated with a higher risk for Alzheimer’s. Shortly after, Niles became a participant in an Alzheimer’s study for monoclonal antibody Alzheimer’s drug donanemab, which received full FDA approval and hit the market in July 2024 under the brand name Kisunla.

“They found a left bundle branch block in my
heart in one of their analyses, which
I would have never discovered.”

Niles said one of the main benefits for him personally was the thorough medical care he received for free, where doctors discovered certain health issues that otherwise may have gone unnoticed. “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,” Niles said. “They found a left bundle branch block in my heart in one of their analyses, which I would have never discovered.”

Niles experienced no side effects from taking donanemab during the trial, but six months into the trial the amyloid plaque in Niles’ brain was not eliminated sufficiently by donanemab.

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

Leah Fisher: A rocky experience

Leah Fisher, a retired psychotherapist, received a mild cognitive impairment (MCI) diagnosis and later participated in a study for neurologists.

Fisher first noticed a series of unusual behaviors in her life like leaving things behind, dropping essential items like her passport, and spilling coffee on her counter — ultimately, these were early signs of MCI. Leah’s neurologist informed her of a clinical trial looking for new participants. The study’s purpose was to understand whether the treating physicians would practice earlier intervention if they had information from a PET scan to validate whether or not the patient had signs of dementia.

“It was offered to me as a way to have a PET scan,” Fisher said, noting that the out-of-pocket costs of a PET scan were a concern.

Fisher’s PET scan revealed there was presence of amyloid in all the lobes of her brain. Her primary goal to receive a PET scan and more information about the progression of her MCI were both achieved during the study. But Fisher noted her trial participant experience was not entirely positive — Fisher was upset by the lack of empathy and communication skills of the neurologist who was hired to deliver her results during the study.

My personal dream would be to be part of
an advisory group to a facility that could give
feedback about our own experience.”

“My personal dream would be to be part of an advisory group to a facility that could give both feedback about our own [trial participants’] experience and input about how it [delivery of diagnosis] can be done in a more sensitive and informative way by feeling out the person you’re talking to and using that information to decide how to continue the diagnosis,” she said.

‘If I Don’t Forget:’ Leah Fisher on Living With Uncertainty After an MCI Diagnosis

 

Bill Sasse: Hungry for more data

Like Niles, Bill Sasse had a family history of Alzheimer’s — his father died from the disease. Sasse was a participant for seven years in Eli Lilly’s clinical trial of the experimental monoclonal antibody drug solanezumab, which was discontinued in March 2023 after failing to hit its benchmarks in slowing cognitive decline. At the initial screening to determine if Sasse was eligible to participate, physicians discovered that amyloid plaque was present in Sasse’s brain through a PET scan.

When asked about side effects from solanezumab, Sasse said he had “none whatsoever, from start to finish.” While Sasse underwent two or three PET scans during the course of the study, he said he never was shown the results of the scans.

“That would be probably my one criticism of the trial: I would have liked to have known if there was any physical change in my brain, which the PET scan would have revealed. I asked at the time, but I have not asked since, and I don’t know how much information they get at the test site as far as the results.”

“I would have liked to have known if there
was any physical change in my brain,
which the PET scan would have revealed.”

Bill Sasse: An Insider’s Account of the Alzheimer’s Solanezumab Drug Trial

Dewayne Nash: Hope and access

Retired family physician Dewayne Nash was diagnosed with mild cognitive impairment (MCI) at the age of 60 and has participated in two research trials, an ADNI study focused on diagnostic testing and a study for Biogen’s Alzheimer’s drug Aduhelm, which gained FDA approval but was discontinued in 2024.

Participating in the Aduhelm trial gave Nash hope for his condition.

“It gave me access to a drug that may slow the disease down. I’ve been able to access [the drug] five, six years before others have been able to. One thing this drug had given us was some hope.” Nash did not share whether or not he had been told of his condition’s progression through a PET scan administered by his doctors.

“It gave me access to a drug that
may slow the disease down.”

Despite having a positive experience in the trial, Nash expressed that he is conflicted by the timing of the FDA’s approval of Aduhelm.

“I’m glad that they approved it, and I think they should have approved it, but I think they went about it wrong. It just smells bad. They could have waited two or three years [for more research],” Nash said. “They approved it too soon. Look at all these well-respected neurologists and what they say about it. A lot of them are for it but a lot of them are against it, and that’s a red flag.”

‘Some Hope Over No Hope:’ A Retired Doctor on Alzheimer’s Diagnosis and the Aduhelm Trial

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