EXCLUSIVE ‘This is our only hope’: Families torn apart by Alzheimer’s say blockbuster new drug has given them precious time with dementia-ridden loved ones – as doctors remain split over its effectiveness
Pictured above is Jim Sirois and his wife Sue from Berlin, Connecticut. Jim was diagnosed with early stage Alzheimer’s more than three years ago. Since getting donanemab, Sue said his disease ‘really hasn’t progressed’
Patients and families involved in trials of a new blockbuster dementia drug say it finally offers patients a glimmer of ‘hope’.
Jim Sirois, now 67, from Connecticut, was diagnosed with early-onset Alzheimer’s in 2020 after he had trouble speaking and became so forgetful he couldn’t remember where he had been the previous day.
An early diagnosis of Alzheimer’s disease usually indicates a rapid decline. Memory, thinking, judgment, language, problem solving, personality and movement all begin to be affected by the disease as it progresses and so far no drugs have been able to stop it.
Patients normally deteriorate rapidly at this point – and no drugs have been available to halt the decline for decades. But Mr. Sirois was enrolled in the drug arm of a clinical trial of the groundbreaking new drug donanemab, which his wife says has effectively stopped the condition for the past year.
Sue Sirois, 64, said: “I compare Jim’s decline to a friend I know who was diagnosed with Alzheimer’s at age 56. She passed away recently and has only lasted six years, while Jim has been at it for over three years now and is still pretty much the same as he was.’
Trials of donanemab showed that it slows the progression of Alzheimer’s disease by up to 60 percent compared to a placebo, helping patients live extra healthy lives for months.
But some doctors have taken a cautious note, saying the gain is marginal for most patients – for example, it only exacerbates the worsening of symptoms for just over half a year on average.
However, Ms Sirois said, after decades of failed trials and no new drugs, donanemab finally gives patients ‘hope’.
She told DailyMail.com, “I would say those who have the chance to get this drug should go for it and get it because what else have you got? What other hope do you have? This medicine is the only hope people have now, there is no other hope for the disease.”
Myra Garcia, of Southern California, pictured above with her husband Richard, was also given the drug after being diagnosed with early-onset Alzheimer’s. She told DailyMail.com that anyone given the chance should take the drug
Florida’s Mary Daniels, however, took a more cautious tone. She said drug companies were pressuring the treatment because it was the ‘best available’, but for many she feared it wouldn’t help much
She added, “Jim really hasn’t progressed much in a year and a half now. From this summer to last summer there is only a slight decline.’
He’s still able to wash himself, dress himself and get his food — though he may need to be reminded, she told this website.
Other patients in trials of the drug praised it for helping them continue to do “normal things,” such as going to classes and doing laundry.
The drug – created by Eli Lilly – becomes the second ever shown to help slow the decline of Alzheimer’s patients.
It is a monoclonal antibody that works by attaching to amyloid beta proteins in the brain that have formed plaques.
This prompts white blood cells to come and clean up the proteins. It is given as a monthly infusion.
Mr. Sirois participated in the TRAILBLAZER-ALZ 4 trial of the drug and began receiving infusions every month in November 2021.
Speaking about how his illness has developed with her husband over the past year, Ms Sirois said: “I don’t see a major decline in his illness at the moment, my care is really just to remind him to do things, remind him to take his pills, but he can still do it alone.’
Myra Garcia, 64, of Southern California, is also receiving donanemab after being enrolled in a separate study.
She told DailyMail.com, “I would get this drug approved tomorrow if I could.
“I can imagine that I would gradually lose my skills if I did not use this drug.
“What I remember about my mother’s sisters [who had Alzheimer’s]was that at first you don’t even know what’s going on, but then they just start losing and losing and losing, and that’s the hard part.”
Ms. Garcia, who told DailyMail.com that she took a French class before our interview, added: “I am one of the lucky ones to participate in this process and have access to the drug.
‘I’m in three choirs, my church choir, the Hillcrest choir and a Bach choir.
“I also exercise with my husband, we do something together every morning, but then I cook and do the laundry and the things everyone else does.”
She added, “It worked for me. I think it turned out beautifully.’
Eli Lilly and Company said it had already sought approval from US regulators, the Food and Drug Administration (FDA).
The US pharmaceutical giant said it expected to file an application with UK regulators within six months. It means patients can be treated with the drug within 18 months.
Donanemab has been shown to halt mental decline for more than a year in about half of the patients. It was most effective in people under age 75 in the earliest stages of the disease, the new results showed.
Sue said her husband had seen little improvement since he started taking donanemab
Ms Daniels had to wash up at her husband’s care home during the pandemic to see him. She was instrumental in lifting the ban on visits to care homes
Researchers examined nearly 1,800 people with early-stage Alzheimer’s disease, with patients given either donanemab or a dummy drug for 18 months.
Those in the very earliest stage of the disease, known as mild cognitive impairment, had the greatest benefit, with a 60 percent delay compared to placebo.
In early Alzheimer’s patients whose brain scans showed low or average levels of a protein called tau, the drug was found to slow clinical decline by 35 percent.
Levels of tau are a marker of how far the disease has progressed. When the results were combined to include people who had higher levels of that protein, there was a 22 percent slowdown in disease progression.
Researchers said some patients were taken off the drugs after just six months because scans showed that the amyloid in their brains had completely disappeared.
Comparing it to radiation for cancer, they said the treatment could then stop — with early indications suggesting the plaques, which were decades in the making, would take several years to return.
The drug works by using the immune system to clear amyloid — toxic plaque buildup in the brain that stops brain cells from communicating.
Consequently, it is only effective for people with early-stage Alzheimer’s disease and not for other forms of the disease, such as vascular or frontotemporal dementia.
Mary Daniels, a 60-year-old patient advocate in Florida, lost her husband Steve to early-onset Alzheimer’s disease in December 2022 after a decade-long battle with the disease.
Speaking to DailyMail.com, she said she wasn’t convinced the drug would work.
Ms Daniels said: ‘I don’t think this drug is what they say it is. If you dig deep into it, I think they almost sell it to you because they’re hopeful and want you to buy it.
“This isn’t going to significantly improve anyone’s life. I hope I’m wrong. I hope my jaded attitude is wrong, but I don’t think so.’
Ms Daniels explained how her husband had been in clinical trials for the drug solanezumab – another monoclonal antibody that attaches to a different region of amyloid proteins in the brain.
The trials were launched in 2014 and lasted until 2017, when they were halted after the treatment failed to produce any noticeable improvement for the patients.
However, Ms. Daniels only found out about this when she read the paper – instead of contacting the pharmaceutical company.
When she called Eli Lilly, who developed the drug, to complain, the company explained that its first order of business was to inform shareholders rather than the patients who had traveled to get the drug.