![Researchers have made a breakthrough with a Alzheimer’s drug [Lecanemab] that is being hailed as “pivotal” for the future of drug and therapy development targeting Alzheimer’s diseases and cognitive decline.
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The drug is an anti-amyloid beta protofibril antibody, that treats cognitive decline in patients suffering from Early Alzheimer’s (also known as mild Alzheimer’s) and late Alzheimer’s disease. According to Biogen, the drug met the statistically significant endpoint of the primary goal, that is when compared to the placebo, it showed 27% effectiveness in curbing global cognitive and functional decline. The study was performed for 18 months. The drug is developed by Eisai, a Tokyo-based pharmaceutical company, in association with Biogen (Cambridge, Massachusetts). The drug, lecanemab is a monoclonal antibody, its function is to clear away the protein clusters seen in the brain during the occurrence of the disease. These protein clumps are the reason for the disease Alzheimer’s. amyloid beta protein is toxic to the brain and as it deposits inside the brain it causes dementia and other functional disorders.
Caleb Alexander, an epidemiologist at the John Hopkins Bloomberg school of public health says, the results are quite promising and the scientific community is quite eager to see the full analysis of the trials. Another scientist and neurologist from Indiana University school of medicine, Liana Apostolova says that this drug and its results are a great win for the field of Alzheimer’s research. Some scientists however prefer to wait than gush on the new discovery, Brent Forester says that more study is required on the hypothesis of the amyloid protein itself. Brent Forester is the director of the Geriatric Psychiatry research program at McLean hospital. He also helped run the clinical trials for the aforementioned drug. George Perry from the University of Texas says that amyloid buildup is an associated problem of Alzheimer’s disease, not the main problem. Skeptics of the amyloid hypothesis are saying that this drug can modulate and bring about small changes but cannot fight the root cause of the disease.
The drug was given to 1800 patients with a diagnosis of early-stage Alzheimer’s, the drug was given to the patients twice weekly, and the drug was given to them intravenously. It showed the results of reduced toxic plaques of clumps of Beta-amyloid proteins in the brain. It also shows the slowing of patient's memory loss and performance of the day-to-day activity.
This drug may have divided the scientific community but it is nothing short of historic. Tens of millions of people suffering from cognitive decline, and dementia worldwide would appreciate even the barest of hope that something is being done to curb this painful and saddening disease. The Alzheimer’s Association has said that this drug has not only brought hope to the people but also encouraged others to bring forth effort to do more research on treatment against the underlying causes of Alzheimer’s disease.
Dr. Susan Kohlhaas, the director of research at Alzheimer’s Research UK says, this drug is a historic moment for the research ongoing against dementia. Since this is the only drug that was showed to slow down cognitive decline, in the initial phase 3 trial of the drug.
Alzheimer's have been ailing tens of millions of people, any ray of hope will be beneificial not only for the people suffering from the disease but it will also give encouragement and a drive to do more research on drug development against Alzheimer's and other related diseases.
Dr. Deepanjan Roy, MBBS, MD-Medicine(PGY1) [SCB Medical College and Hospital Cuttack]
The results of the drug was calibrated using an 18-point scale called Clinical Dementia Rating- Sums of Boxes (CDR-SB) this method was used to calculate the score by a patient by the method of interviews conducted with the patients and their caregivers. Then the tests were given where the patient's abilities of problem-solving, memory and other cognitive aspects of the brain were tested. The test showed that lecanemab decreased the plaques as well as the patients scored 0.45 points on average in the CDR-SB scale when compared to the placebo group after 18 months of conducting the trials.
Rob Howard says that the results have a tiny difference with the placebo groupings. The minimum worthwhile range is from 0.5 to 1.0. So it’s a wait-and-watch game for the makers of the drug to discuss the future of the drug. Rob Howard is a professor of old age psychiatry at University College London.
Eisai and Biogen are expected to approach the FDA in US and authorities in Europe for regulatory approval.
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