After losing three generations of his family to dementia, George Vradenburg co-founded UsAgainstAlzheimer's, an organization dedicated to Alzheimer’s research.
In the past 40 years he has lost his grandmother, his mother and a sibling to the crippling disease. “And if we don't pick up the pace on getting at this disease, it's my kids and my grandkids that are right in the bullseye,” Vradenburg told Yahoo News. “I'm fighting for my family.”
Over 6 million Americans are living with Alzheimer’s, an incurable disease that affects the brain and causes loss of cognitive function over time. However, experts say there is hope on the horizon, after lecanemab, an experimental drug, slowed the cognitive decline of Alzheimer's by 27% in a global clinical study.
The study was performed by two pharmaceutical research companies, Eisai and Biogen. They reported that their Clarity Ad Phase 3 clinical trial of lecanemab presented encouraging results in an 18-month trial. The clinical trial included 1,795 diverse patients with early-stage Alzheimer’s and showed “highly statistically significant reduction of clinical decline,” Eisai stated in a press release on Sept. 27.
For many, this proves that the investments into dementia research are paying off. Annually, the federal government invests $3.1 billion in dementia research.
”This is a game changer. This is a drug that demonstrates in this large, diverse, phase 3 trial that by reducing amyloid and by reducing tau, there was a clinical benefit to modify the course of this disease,” Vradenburg said.
Amyloid and tau are two proteins in the brain that control thinking and memory. “This is the first time that a clinical trial has demonstrated [that] the reduction of amyloid and tau actually produces a clinical benefit,” he added. “This is historic.”
The trial also reported that 25% of the participants enrolled were from underrepresented populations. Maria Carrillo, the Alzheimer’s Association chief science officer, says diversity is a crucial factor to consider in any research. According to the Alzheimer’s Association, over 20% of Black Americans 70 and older are living with the disease, and they are twice as likely to get dementia.
“We're very hopeful that as we get better at enrolling the right populations, as we get better at the science, we are able to actually see treatments come to the clinic and be accessible to people who may be able to benefit from them,” Carrillo said.
While the impact of lecanemab seems positive, experts say Food and Drug Administration approval is crucial for the drug to become readily available to those who need it most.
“The company has announced that it will be filing not only with the FDA, but [also] with other countries and regulatory agencies. And we hope that soon, the FDA might have an expedited review of this drug,” Carillo explained.
In a press release, Eisai said it “aims to file for traditional approval in the U.S., and to submit marketing authorization applications in Japan and Europe by the end of Eisai FY2022, which ends on March 31, 2023.”
Biogen and Eisai have an application pending for accelerated FDA approval, and a decision is expected by early January.
Experts believe lecanemab will get FDA approval and Medicare coverage, unlike aducanumab, which is sold as Aduhelm, a prior Alzheimer's drug from Biogen that was approved by the FDA but received limited Medicare coverage. “This drug [lecanemab] has a much larger trial, much more diverse trial, and much clearer evidence of clinical benefit,” Vradenburg explained.
But the side effects are concerning. “Lecanemab also has a similar profile of dangerous side effects related to brain swelling and brain bleeding that we see with Aduhelm, though lecanemab is probably a bit friendlier than Aduhelm on this front, in that ‘only’ 10% of patients in the high-dose groups showed these side effects [in the phase 2 trial],” Dr. Michael Greicius, a professor of neurology and neurological sciences at Stanford University in California, told Healthline.
If the drug is approved by the FDA, organizations like UsAgainstAlzheimer's say they will push for Medicare coverage. “Medicare must cover it. Otherwise, we're going to be waiting for another five or 10 years before a disease-modifying drug gets to work,” Vradenburg said. “This is an opportunity to change the course of our lives.”
But other experts raised concerns about the potential cost of the drug. Dr. Constantine Lyketsos, a psychiatrist who teaches at Johns Hopkins School of Medicine, told CNN he would be reluctant to prescribe lecanemab to a patient. “If it was a simple pill, if it wasn’t very expensive, I might,” he said.
CNN noted that aducanumab costs about $28,000 for a year of treatment. Eisai told the news outlet that lecanemab hasn't been priced yet.
This year, more positive results are expected from additional clinical trials. In November, at a conference in San Francisco on the 15th annual clinical trials on Alzheimer's disease, other companies working to combat the disease will share their findings. “We also expect that gantenerumab, from a company called Roche, will report next month their top level,” Carrillo said.
Several companies are researching how to stop the progression of the disease, as the number of Americans living with Alzheimer's is projected to double, to 13 million, by 2050, according to the Alzheimer's Association.
Even though this apparent breakthrough is not a cure, it could give those suffering with the life-threatening disease more time. “Slowing is really critical, especially earlier in the disease, when you can be more independent for a longer period of time,” Carrillo said.
Most importantly, “time with families, time to see a grandchild get married, have a bar mitzvah or confirmation — that time with family for an extra two to three years is priceless,” Vradenburg said.