A nationwide clinical trial is testing whether an existing drug could benefit patients with Alzheimer's disease, in hopes of making symptom-improving medication more accessible for people experiencing mild cognitive impairment.
Patients participating will be helping to determine the potential benefits of taking a drug called benfotiamine— which researchers believe may delay or slow the progression of symptoms of early Alzheimer's disease.
Researchers say this treatment could be especially beneficial because the drug is converted by the body into Vitamin B1, or thiamine. That could lead to a better safety profile, be more cost-effective and be more accessible than other Alzheimer's medications, according to the researchers.
The nationwide clinical trial, called BenfoTeam, is being locally administered by MedVadis, a partner of Boston Advanced Medicine based in Waltham.
Dr. David DiBenedetto is the practice's director of research and is a principal investigator in the study.
"If patients are having problems managing their activities of daily life — whether it's, again, keeping appointments, performing simple tasks or remaining independent — if we see improvements in those domains, it would mean something significant with this medication," DiBenedetto said.
Alzheimer's can have wide-ranging symptoms including memory loss, problems concentrating and thinking, even changes in mood and personality, according to Mayo Clinic. Over six million people 65 and over have the disease in the United States. In its advanced stages, Alzheimer's can cause complications that lead to death, including dehydration and infection.
At this time, there is no cure for Alzheimer's.
Patients in this study would have early forms of the disease, meaning their symptoms would mainly be limited to mild difficulties during everyday memory recalls and other tasks. Participants will either be given the benfotiamine or a placebo pill and will be followed for 18 months.
"The research is being done to determine the exact benefits of this drug," DiBenedetto said. "Hopefully it's not just slowing down the cognitive decline, but also reversing or improving cognitive function."
DiBenedetto said small studies have suggested that benfotiamine can improve cognitive function in Alzheimer's patients. The BenfoTeam trial is much larger, involving over 400 patients at 50 sites across the United States.
Alzheimer's patients hope participation in clinical trials can lead to a future cure
"I've done research for many, many years — this population of patients is the most altruistic and the most wonderful patient to work with," DiBenedetto said of Alzheimer's patients. "When they come in here, most times they're looking for a solution for the grandkids or for the people in our community."
That's the case for Tim Muther of Holliston. Now in his late 70s, he is living with Alzheimer's and is participating in a clinical trial in hopes of helping to contribute to the search for a cure.
It's an emotional topic for Muther. On top of living with the condition himself, he watched his father and mother-in-law decline from the illness.
He first began noticing his own cognitive decline while living in Florida, before moving back to Massachusetts to be closer to family.
"Forgetting things, you know, things that I either should have done or, you know, or things that I felt that I should know that answer," he said. "They just weren't there."
Muther was prescribed a medication by his doctor, and is also participating in a clinical trial separate from the BenfoTeam trial.
"I'm hoping that by me participating and maybe I'll give some hope to others," he said. "I can feel some benefits from what I've been doing... I am holding my own."
One of Muther's children, Wendy Saracino, said it's been hard to watch her parents manage the condition.
"We have regular sort of family Zoom meetings and talk about how it impacts us, how it's impacting our parents, what we can do," Saracino said, who helps her father to participate in his clinical trial. "It actually is helping me be a better, I think, a better daughter, a better caregiver, doing my job here better because I feel like I'm making a difference."
With so much research into Alzheimer's, DiBenedetto said there's been no better time to have hope than now, and showed his gratitude to people like Muther for the critical role they play in medical breakthroughs.
"Everything that's come out in the market is because of people like Tim participating in trials," he said. "So I hope that people will well consider participating in research trials that can actually end this disease."
Currently, there are three FDA-approved drugs to treat symptoms related to mild to moderate Alzheimer's. Since last summer, the FDA has also approved two other Alzheimer's drugs that have been shown to modestly slow a decline in memory and thinking.
The BenfoTeam trial is still seeking study participants. More information is available here.
