Eli Lilly’s Donanemab Shows Promise in Slowing Alzheimer’s Progression, Despite Side Effects

Eli Lilly’s Donanemab Shows Promise in Slowing Alzheimer’s Progression, Despite Side Effects

In a recent 18-month trial, pharmaceutical giant Eli Lilly has made significant strides in the treatment of Alzheimer’s disease with their drug, donanemab. The trial results revealed that donanemab has the potential to delay the progression of this debilitating disease by up to 35.1 percent. This breakthrough offers hope for patients in the early stages of Alzheimer’s, despite the severe side effects associated with the treatment.

The trial demonstrated that donanemab, once approved by the US Food and Drug Administration (FDA), will become the third medication available for the treatment of Alzheimer’s in the United States. Patients who received donanemab infusions experienced a slowdown in their decline by an average of 4.4 to 7.5 months. This significant finding provides a glimmer of hope for individuals in the early stages of the disease, as it offers the possibility of preserving cognitive and functional abilities for a longer period of time.

Despite the promising efficacy of donanemab, it is crucial to acknowledge the presence of severe side effects. Out of the 860 patients who received donanemab infusions, over 6 percent experienced symptoms such as confusion, headaches, seizures, and brain bleeds. Tragically, three deaths were thought to be related to the treatment. These findings emphasize the need for careful consideration of the potential risks and benefits associated with donanemab. While the drug has shown its effectiveness in the early stages of the disease, physicians must weigh its benefits against the potential harm it may cause.

Despite the side effects, the availability of a third potential treatment for Alzheimer’s disease represents a significant milestone after years of limited clinical progress. Doctor Gil Rabinovici and neuroscientist Renaud La Joie from the University of California San Francisco expressed optimism about the future of molecular therapies for Alzheimer’s disease and related neurodegenerative disorders. In an editorial in the Journal of the American Medical Association (JAMA), they described this development as the “opening chapter” of a new era in the treatment of these devastating conditions.

Donanemab, developed by Eli Lilly and Company, is an anti-amyloid monoclonal antibody specifically designed to target amyloid-beta proteins in the brain. This drug belongs to the same category as the other two FDA-approved treatments for Alzheimer’s, aducanumab, and lecanemab. The accumulation of amyloid-beta is closely associated with the progression of the disease, and current research suggests that removing amyloid plaques could potentially help treat Alzheimer’s.

The Phase 3 trial of donanemab involved 1,736 patients randomly assigned to receive donanemab or a placebo intravenous infusion every four weeks for 72 weeks. Cognitive and functional abilities were measured using the integrated Alzheimer Disease Rating Scale (iADRS) and the Clinical Dementia Rating Scale (CDR-SB) at the beginning and end of the trial. Brain scans were also conducted throughout the study to measure the levels of amyloid-beta plaques and abnormal tau proteins.

This trial was unique because it divided participants into groups based on their tau pathology levels, as high tau pathology is typically associated with more advanced Alzheimer’s. The analysis revealed that the progression of the disease was slowed by over 20 percent in the group receiving donanemab compared to the placebo group. Among individuals with low or medium tau pathology, the progress was even more significant, with a 35.1 percent reduction based on the iADRS. Remarkably, 47 percent of the low/medium tau group receiving donanemab showed no change in their CDR-SB rating after one year, compared to only 29 percent of those who received the placebo. However, no significant improvement was observed in the high tau group compared to the placebo group.

Throughout the trial, some patients who achieved substantial clearance of amyloid-beta plaques were switched from the drug to the placebo unknowingly. This was done in an attempt to reduce unnecessary treatment and costs, and it occurred in 52 percent of the low/medium tau patients in the experimental group. The substantial clearance of amyloid-beta plaques and the relatively mild clinical impact observed shed light on the complexity of Alzheimer’s disease itself. These findings suggest that amyloid may not be the sole contributor to the progression of the disease, highlighting the need for further research and data.

It is important to note that the study has some limitations. The majority of participants were of White ethnicity, and the age range was limited to individuals between 60 and 85 years old. The trial also ended after 18 months, although an extension is currently being planned. Further research and data are necessary to determine the specific population that would benefit the most from donanemab and to assess the potential side effects. Despite these limitations, the availability of a new treatment option offers hope to individuals seeking to delay the onset of Alzheimer’s disease by even a few months or years.

Eli Lilly’s donanemab has shown potential in delaying the progression of Alzheimer’s disease, despite the presence of side effects. This breakthrough offers hope for patients in the early stages of the disease and marks an important milestone in Alzheimer’s treatment. However, careful consideration of the potential risks and benefits is necessary, and further research is required to determine the specific population that would benefit the most from this drug. With the availability of a new treatment option, there is renewed optimism for individuals affected by Alzheimer’s disease and their families.

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