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Alzheimer’s patients and their loved ones have new reason for hope after positive results from clinical trial of a new treatment called lecanemab.
Lecanemab – a drug designed to slow the progression of Alzheimer’s disease by targeting amyloid plaque buildup in the brain – reduced the progression of cognitive decline among trial participants by 27% over 18 months, compared to placebo, according to UsAgainstAlzheimers.
“This is very important and quite positive news that gives our nation’s 6 million Alzheimer’s patients and their loved ones reason to hope again. In fact, the data is a reminder that each drug in this class of therapies is quite different,” said George Vradenburg, chair and co-founder of UsAgainstAlzheimers.
What do the results show, and how will Latinos be impacted?
Why Is Alzheimer’s Important to Address in Latinos?
By 2030, 40% of Alzheimer’s patients in the U.S. will be Latino/Black.
Latinos are one and one-half-times more likely than Whites to have Alzheimer’s and other dementias.
Further, Latinos patients may not be able to get the care they need if diagnosed with Alzheimer’s disease or dementia. One-third of Latinos (33%) report that they have experienced discrimination when seeking health care, according to the Alzheimer’s Association.
This is likely a reflection of historical and present-day systemic racism and social inequities that affect brain health and access to healthcare.
What Do the Lecanemab Clinical Trial Results Show?
The 18-month study took place in Japan, the U.S., Europe, and China.
The treatment group was administered a dosage of 10 mg/kg bi-weekly of lecanemab, with participants allocated in a 1:1 ratio to receive either placebo or lecanemab.
Lecanemab, also known as BAN2401, is a potential immunotherapy for Alzheimer’s disease being jointly developed by the U.S.-based biotechnology company Biogen and the Japanese healthcare company Eisai, as reported by Alzheimer’s News Today.
Eisai and Biogen announced that lecanemab reduced clinical decline compared with placebo by 27% in a cohort of 1,800 study participants. Those receiving treatment also fared better in interviews and tests of memory and problem-solving.
Some are hesitant as to the degree of the drug’s impact, but others are hopeful.
“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” said Michel Vounatsos, CEO at Biogen, in a press release.
“Importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease. We want to thank the many patients who participated in this groundbreaking global study and want to acknowledge the clinical investigators who worked tirelessly to increase the enrollment of traditionally underrepresented populations. As pioneers in neuroscience, we believe defeating this disease will require multiple approaches and treatment options, and we look forward to continuing the discussion about the significance of these findings with the patient, scientific, and medical communities.”
How Diverse Were the Lecanemab Clinical Trial Participants?
Clinical trials are studies that help researchers learn more to help slow, manage, and treat Alzheimer’s for current and future family members.
But without Latino volunteers for clinical trials, the benefits may miss this group.
Despite the historical underrepresentation of Latinos and other racial/ethnic minorities in clinical trials, 25% of the U.S. participants in the clinical trial of lecanemab were from underrepresented populations.
“This is a significantly higher percentage than what is typically seen in clinical trials, which ranges from 1-5% of people from historically underrepresented communities,” according to a blog by the Alzheimer’s Association.
What Comes Next?
In July 2022, the US FDA accepted Eisai’s Biologics License Application for lecanemab under the accelerated approval pathway and granted Priority Review.
The Prescription Drugs User Fee Act action date is set for Jan. 6, 2023. The FDA has agreed that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.
To secure traditional FDA approval for lecanemab as soon as possible, Eisai submitted the BLA through the FDA’s Accelerated Approval Pathway so that the agency could complete its review of all lecanemab data except for the data from the confirmatory clinical trial.
Eisai will discuss this data with regulatory authorities in the U.S., Japan, and Europe and aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai’s FY2022, which ends on March 31, 2023.
“Patients can’t wait for treatment. We hope the FDA approval process is quick and that, once approved, CMS will do the right thing and cover it,” Vradenburg said.
Eisai will also present the new positive results on Nov. 29, 2022, at the Clinical Trials on Alzheimer’s Congress Conference.
“Alzheimer’s disease not only presents a great challenge for patients and their families, but it also negatively impacts society, including decreased productivity, increased social costs and disease-related anxiety. We believe that helping to alleviate these burdens will positively impact society as a whole,” said Haruo Naito, CEO at Eisai in a press release.
Be The Representation in Clinical Trials
While studies like the clinical trial of lecanemab showed diversity within their trial participants, representation is still needed.
Dr. Amelie Ramirez, director of Salud America! at UT Health San Antonio, is working to create ways for Latinos to participate in clinical trials thanks to a grant from Genentech, a member of the Roche Group.
“With more Latino volunteers for clinical trials, researchers would have greater opportunity to find better prevention and treatments for diseases that affect this population,” Ramirez said.
Visit the Salud America! clinical trials page to learn more about volunteer opportunities and how you and your familia can participate.