By Deborah Jeanne Sergeant
Currently, more than six million people in the US live with Alzheimer’s disease and 410,000 of those live in New York. By 2050, those figures are anticipated to double, according to the Alzheimer’s Association.
Eisai and Biogen’s lecanemab, in phase 3 of its clinical trial, has been shown to slow the rate of cognitive decline caused by Alzheimer’s by 27%. The anti-amyloid monoclonal antibody drug is meant for people with mild cognitive impairment.
Cathy James is the chapter executive of the Alzheimer’s Association, Central New York Chapter.
“These are very, very encouraging results in clinical trials in treating the underlying cause of Alzheimer’s,” said James. “Currently, the medications available right now help with the symptoms of the disease. It’s very important that we’re finding and approving medications that help with the underlying cause.”
Time is not on the side of people with Alzheimer’s and their families. With Lecanemab slowing the disease’s progression, they will have more time.
“For people in the earliest stages, this can change the course of the disease in a clinically meaningful way,” said James. “Lecanemab may give people more time at or near their full abilities to participate in daily living skills, remaining independent and making future care decisions. There are a lot of legal and financial decisions the family and person diagnosed need to make.”
More detailed results yet forthcoming will give a better indicator as to how much time patients will have near their baseline cognition while using lecanemab. It is also not yet clear as to the side effects.
Contraindications are not yet available. They are especially important for older adults who may be taking other medications for unrelated health conditions.
“The main issue is that we have not had any medications that actually change the course of the disease,” said Sharon Brangman, chairwoman of geriatric medicine, director of the Geriatric Medicine Fellowship Program and director of the Upstate Center of Excellence for Alzheimer’s Disease at SUNY Upstate Medical University. “The current medications treat the symptoms but don’t delay the progression of the disease.”
Although not cures, medications such as lecanemab are part of a group of drugs under much research currently. Current medication for Alzheimer’s disease only treats symptoms. Lecanemab works by combating the excessive accumulation of amyloid proteins in the brain, which is believed to be the cause of Alzheimer’s.
Brangman said that while lecanemab breaks down and removes the amyloid, it may cause swelling of the brain and bleeding. However, “for most people, this doesn’t seem to be very serious,” she said. “We’re awaiting information on its safety and efficacy.”
Providers would need to look at each patient’s comorbidities and medications to assess risk.
Brangman noted that although Alzheimer’s affects each race, Blacks have double the risk and Hispanics are at 1.5 times the risk Hispanics compared with whites. Twenty-five percent of the participants in the lecanemab research were Black and Hispanic.
“Most pharmaceutical companies have not made efforts to reach all members of our community and all age groups,” Brangman said.
She added that in April, the FDA began requiring pharmaceutical researchers to submit a recruiting program that demonstrated recruitment across racial groups to better ensure solid representation.
After FDA approval, health insurance coverage for the new drug depends upon whether Medicare and Medicaid Services provide coverage. Most health insurance companies follow their lead. The only other anti-amyloid treatment, Aduhelm, would have cost $30,000 per month out-of-pocket. In a similar class as lecanemab, Aduhelm was also an infusion drug, but was not approved by the FDA.
“Alzheimer’s is a very complex disease,” Brangman said. “Some people may enter it through different pathways. If you enter through the amyloid pathway, this may help. We have to address all the different pieces here. I wouldn’t be surprised that we’ll have to look at each person’s profile and come up with a cocktail of drugs beneficial for them.”
Support and information from the Alzheimer’s Association are available for free anytime, day or night for individuals with Alzheimer’s disease and their caregivers at 800-272-3900.