WASHINGTON. Researchers reported Monday that another experimental Alzheimer’s drug can modestly slow the inevitable worsening of the disease, extending patients’ functional abilities by about four to seven months.
Eli Lilly and Co. is seeking approval from the Food and Drug Administration (FDA) for donanemab, a lab-made antibody administered through intravenous (IV) infusion. If approved, it would become the second Alzheimer’s treatment to convincingly demonstrate a delay in the progression of the mind-robbing disease, following the recent approval of Leqembi, a drug from Japanese pharmaceutical company Eisai.
Lilly’s Dr. John Sims expressed hope during the Alzheimer’s Association International Conference in Amsterdam, stating that even though the disease cannot be cured, meaningful treatments are still possible, akin to how diabetes is managed with treatment rather than cured.
In May, Lilly announced positive results from the study involving donanemab, and on Monday, the full study, which included 1,700 patients, was published by the Journal of the American Medical Association and presented at the Alzheimer’s conference.
Both donanemab and Leqembi target sticky amyloid buildup in the brain, a key culprit in Alzheimer’s disease. However, they come with a significant safety concern — brain swelling or bleeding, which was linked to three deaths in the Lilly study.
Scientists believe these drugs may usher in a new era of Alzheimer’s therapy, but they acknowledge that many questions remain unanswered, particularly concerning which patients should try the drugs and the actual benefits they may experience.
Dr. Eric Widera of the University of California, San Francisco, wrote in an accompanying editorial in JAMA that the modest benefits of amyloid-targeted therapy would be more widely accepted if the drugs were low-risk, inexpensive, and easy to administer. However, these drugs currently lack these qualities.
Lilly’s study involved people between the ages of 60 and 85 who were in the early stages of Alzheimer’s. Half of the participants received once-a-month infusions of donanemab, while the other half received dummy infusions over 18 months.
During the study, patients were switched to dummy infusions if enough amyloid was cleared from their brains, which occurred in about half of the participants within a year. The researchers also tracked levels of abnormal tau, another culprit in the brain responsible for advancing the disease.
The results showed that both groups experienced decline over the 18-month study period, but those given donanemab declined about 22% more slowly. Notably, the drug appeared to be more effective in earlier stages of the disease, as patients with low to medium tau levels experienced a 35% slower decline.
In practical terms, donanemab slowed patients’ worsening by approximately four to seven months, as concluded in the JAMA report. Among recipients with lower tau levels, 47% remained stable after a year, compared to 29% of those who received the dummy version.
Despite the encouraging results, the main safety concern remains brain swelling or bleeding, affecting about a quarter of donanemab recipients. About 20% of patients experienced microbleeds.
Patients receiving any amyloid-targeted therapy require repeat brain scans to monitor these side effects, which can be costly and time-consuming.
Dr. Mark Mintun of Lilly indicated that temporarily stopping donanemab treatment in responsive patients might help manage these challenges. However, more research is needed to determine if patients may need to resume treatment after stopping.
The study’s demographic makeup, with over 90% of participants being white, raises concerns about the drug’s effectiveness in other populations.
While promising, the results from donanemab and Leqembi have rekindled interest in targeting amyloid buildup, additional approaches are needed. Lilly expects results from a late-stage study of a drug that fights abnormal tau, another hallmark of Alzheimer’s, next year.
Si Venus L Peñaflor ay naging editor-in-chief ng Newsworld, isang lokal na pahayagan ng Laguna. Publisher din siya ng Daystar Gazette at Tutubi News Magazine. Siya ay isa ring pintor at doll face designer ng Ninay Dolls, ang unang Manikang Pilipino. Kasali siya sa DesignCrowd sa rank na #305 sa 640,000 graphic designers sa buong daigdig. Kasama din siya sa unang Local TV Broadcast sa Laguna na Beyond Manila. Aktibong kasapi siya ng San Pablo Jaycees Senate bilang isang JCI Senator.
