The FDA approved donanemab, a new drug for early-stage Alzheimer’s disease.
I remember my grandmother, her summer house filled with the smell of freshly baked cookies, the air vibrating with the laughter of my cousins rolling on the floor from her silly jokes. It was the best time of our childhood. I wish it remained the same.
One summer we greeted our grandmom, she didn’t wave back. The look in her eyes, once brimming with mischief, was now sad, devoid of the memories of her cherished grandkids. We were forgotten.
My grandmother’s story is not something unique. Alzheimer’s disease and related dementia robs millions of their memories worldwide. An estimated 50 million people grapple with this heartbreaking reality, and the number is expected to rise dramatically. While there’s no cure yet, research offers a glimmer of hope for the future.
What is Alzheimer’s disease?
Alzheimer’s disease is the most common cause of dementia, accounting for an estimated 60% to 80% of cases. It is a progressive neurodegenerative disorder characterized by a decline in memory, thinking, and behavior. While precise etiology remains elusive, current research suggests a multifaceted interplay of factors. Amyloid plaques and tau tangles, abnormal protein aggregates, are hallmarks of the disease, disrupting neuronal communication.
Additionally, chronic inflammation appears to exacerbate the damage caused by protein buildup. Genetic predisposition plays a role, with certain genes increasing susceptibility. Furthermore, modifiable lifestyle factors like uncontrolled hypertension, diabetes, head injuries, and social isolation may also contribute to the development and progression of Alzheimer’s disease. Approximately 6.9 million Americans aged 65 and older are living with Alzheimer’s dementia in 2024.
Current treatments
There is no known cure for Alzheimer’s disease. However, there are medications and non-drug treatments that can help manage the symptoms of the disease. Current treatment focuses on the different aspects of the disease prognosis, such as removal of amyloid-β plaques by Lecanemab and Aducanumab, inhibition of choline esterase breakdown by Donepezil, and glutamate regulators like Memantine.
Last week the FDA approved a new addition to this list. Donanemab-azbt (Kinsula) by Eli Lilly received green signal for the treatment of adults with early symptomatic Alzheimer’s disease, which includes mild cognitive impairment mild dementia, with confirmed amyloid pathology.
How does Kinsula work?
Amyloid beta plaques are deposits of a protein called beta-amyloid that accumulate in the brain, contributing to the progression of Alzheimer’s disease by disrupting normal brain function and leading to neurodegeneration. KInsula is a monoclonal antibody drug that targets the beta-amyloid peptides. By binding to these peptides, Donanemab facilitates their clearance, thereby reducing the formation of insoluble fibrils that contribute to neurodegeneration.
Kinsula receives approval form FDA
Clinical Studies, Efficacy and and Side Effects
The efficacy and safety of the drug was determined by a Phase 3, double-blind, placebo-controlled study clinical study, TRAILBLAZER-ALZ 2. The study enrolled participants who exhibited early symptoms of Alzheimer’s disease, characterized by the presence of both brain amyloid deposits and tau protein pathology. The study enrolled 1,736 participants, across 8 countries, who received 700 milligrams (mg) of the drug every 4 weeks for up to 72 weeks.
The efficacy of the drug was determined by using the Integrated Alzheimer’s Disease Rating Scale (iADRS). The scale combined scores from two existing tests: one evaluating cognitive function and another assessing a patient’s ability to perform daily activities. The score was finally normalized with other factors like age and existing AD treatment (Memantine).
Treatment with insula significantly slowed cli nical decline in patients with Alzheimer’s disease, with a 35% reduction in decline seen in less advanced cases and a 22% reduction in the overall population, as measured by the integrated Alzheimer’s Disease Rating Scale (iADRS). Additionally, Donanemab treatment was associated with a 39% lower risk of disease progression.
The side effects of the medication include headache, serious allergic and infusion-related reactions like irritation of skin, nausea, vomiting, sweating.
Future of the battle against RSV
Alzheimer’s disease is a devastating illness snatching away individuals from their memories and independence. The development of new drugs, like Kinsula is crucial to offer hope to the patients and their families. With more options on the table, doctors will be equipped to offer better and economical treatment plans, potentially leading to a brighter future for those affected by Alzheimer’s disease.
Dr. Avraneel paul, Ph.D.
Sources
https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf
https://pi.lilly.com/us/kisunla-uspi.pdf?s=pi
https://clinicaltrials.gov/study/NCT04437511
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