In 2012, Geri Taylor was a top manager at a large long-term care facility in the United States New York City when she started experiencing signs of cognitive decline.
Once, the 69-year-old lost her train of thought during a work meeting. Another time she got off at the wrong subway stop and couldn’t remember which stop was home.
Then, one morning later that same year, she was shocked by her reflection in the mirror. She couldn’t recognize herself.
A visit to a neurologist in November that year confirmed the worst: She was in the early stages of cognitive impairment, a precursor to Alzheimer’s disease.
Research shows that about eight in ten patients with so-called mild cognitive impairment (or MCI) will develop Alzheimer’s disease.
And Geri had a feeling that second shoe would soon drop.
Although the disease had not yet reached its full strength at that time, she felt as if she was in a kind of purgatory, awaiting its devastation.
Geri (left) and Jim Taylor (right) spoke to DailyMail.com about Geri’s Alzheimer’s journey and the benefit a now-discontinued drug had for her
The couple took advantage of Geri’s near-normal cognition during the first few years of having Alzheimer’s disease by traveling and speaking at conferences on Alzheimer’s care
Three years later, and while thumbing through the newspapers one morning, Geri’s husband Jim came across a blurb about an early-stage study for a promising new drug for cognitive impairment in the early stages of Alzheimer’s disease.
The drug was called aducanumab. Its approval under the Food and Drug Administration’s accelerated approval pathway was controversial because the scientific evidence that it worked was weak and possible side effects included brain swelling and bleeding.
The couple called Yale-New Haven Hospital about a two-hour drive from their New York City apartment where the trial took place. There were only a few spots left for the test, and Geri grabbed one.
The injectable antibody – a ‘fighter’ protein – is designed to clear amyloid plaque in the brain. This sticky buildup is one of the hallmarks of Alzheimer’s disease, which doctors look for on brain scans.
Geri’s PET scans revealed a significant buildup of amyloid plaque. This, together with her increasingly poor memory, meant she met the requirements to take part in the study.
DNA testing offered clues as to why Geri may have developed the condition relatively young.
She tested positive on both her mother’s and father’s sides for the APOE4 gene variant, which increases the risk of Alzheimer’s disease about eight to 12 times. This means that her son is also susceptible to Alzheimer’s disease.
During the seven-year trial, Geri received a high dose of the actual drug, not the placebo. And it didn’t take long before she felt an improvement in her ability to string sentences together.
Jim told DailyMail.com: ‘OhYour life for the first five or six years (during the trial) was remarkably quiet.”
Geri seemed to benefit from the drug during the trial. She could form sentences and find the right words with relative ease, and it gave the couple a few extra bright years
Together they traveled across the country giving talks at churches and conferences about living with Alzheimer’s disease.
Geri participated in support groups and memory workshops organized by the CaringFriend organization that connects patients and families with healthcare providers.
‘Geri always did 50 percent of the presentation. We went back and forth, kind of like ping pong. And she was able to pack and track our itinerary and really needed very little help from me for many years.
“That made us both excited and feel like she was benefiting from the infusions of the medication.”
During this time, Geri became a social butterfly, eager to meet new people and spend time with those closest to her, making the most of her bright years.
But then the process came to an abrupt end.
In March 2019, Biogen and pharmaceutical partner company Eisai announced they would end the trial in which Geri was enrolled.
This was based on an interim analysis that led to the company scrapping the drug and telling more than 3,000 Alzheimer’s patients they would no longer receive the infusions.
Geri has gone an entire year without the medications that she and her husband believed had contributed to her cognitive decline.
Jim said, “And I noticed that that was the first year she started to struggle with words and just being able to have a conversation. And she noticed that too. And that was confirmation for me that the medicine had helped.’
Aducanumab is a monoclonal antibody made from living cells that bind to a sticky protein called amyloid beta. Amyloid beta proteins occur naturally in the brain.
A brain affected by Alzheimer’s disease overproduces the precursor proteins that generate amyloid beta, which occur in abnormal forms and clump into insoluble clusters.
Every state bar has seen an increase in Alzheimer’s disease fatalities in the two decades to 2021, according to data from the Centers for Disease Control and Prevention (CDC).
These clusters disrupt normal neuronal function and cell signaling pathways, ultimately killing those cells.
Amyloid is a marker of Alzheimer’s disease and a target for several other drugs in the pipeline, in addition to aducanumab. But the scientific evidence that reducing amyloid can alleviate memory and thinking problems is weak.
Clinical trials of other amyloid-targeted drugs over the past two decades have all failed in slow cognitive decline. This has led to some disagreement in the scientific community about whether medications should be hyper-focused on reducing amyloid.
The trial resumed in 2020 and Geri was able to participate again, but she had lost a valuable year of treatment during which her cognitive decline could have been delayed.
The drug has been dogged by controversy since its inception.
The final approval in June 2021 was a source of years of controversy and investigation into possible under-the-table communications between FDA staff and the drug’s manufacturer.
When it was narrowly approved, acceptance was low. Biogen had a sticker price of $56,000 per year.
Considering that the vast majority of Alzheimer’s patients are 65 or older and on fixed incomes, compounded by the fact that Medicare, which provides health care to seniors, limited coverage of the drug, not many people were able to get it .
Earlier this year, Biogen decided to discontinue the drug it had called Aduhelm, which the company said was “unrelated to any safety or efficacy concerns.”
If the trial had not been shortened, it is possible that Geri would have benefited from the IVs.
But by the time the disease started again, Geri’s disease had progressed to the point where she was unlikely to experience any benefit.
Jim said: ‘(New drugs in development) try to catch people who are prone to developing the disease before symptoms actually start.
‘But at this stage and the disease Geri has in her path, I would say there are no breakthrough drugs that can slow cognitive decline for her. The medications at this stage are usually symptomatic medications, which attempt to control behavior, such as sundowning.”
Geri is now in a memory care unit full-time. Last summer, she began experiencing significant sunset symptoms, or confusion in the late afternoon and evening, which can be extremely distressing for patients.
But even without her by his side all the time, Jim has continued his work on behalf of Alzheimer’s patients and their caregivers. They founded Voices of Alzheimer’s on behalf of the approximately six million Americans with the disease.
One of the organization’s first goals was to create a “Bill of Rights” for patients, which demanded ethical treatment by healthcare providers who understand the disease.
Jim recounted a harrowing experience that made it clear to him that such a bill was necessary: “One time Geri was admitted to the hospital and I could not accompany her to her room. And I got to her room 30 minutes later and three assistants were trying to put a hospital gown on her, and she was hysterical.
“So I discovered that assistants aren’t even trained, and that hospitals aren’t trained to differentiate between patients with dementia.”
Currently, there is no cure for Alzheimer’s disease, although there are treatments that can slow the progression of the disease. Aduhelm was the first treatment for Alzheimer’s disease to be introduced to the market in approximately 18 years, leading to approval by the Alzheimer’s Association.
New treatments are being researched and Biogen said it will repurpose resources and apply them to the development of an alternative treatment. But funding for Alzheimer’s research is not as robust as advocates think it should be.
Today, funding for Alzheimer’s disease and dementia research at the National Institutes of Health (NIH) exceeds $3.7 billion annually. By comparison, the National Cancer Institute’s 2023 budget was $7.3 billion.