New Alzheimer’s drug lecanemab shows promising results but raises some questions

New Delhi: A promising new drug to slow the progression of Alzheimer’s disease is set to roll out for approval by the US Food and Drug Administration (FDA) next year.

Promising but not entirely breakthrough results from a Phase 3 clinical trial of lecanemab. It was published In the New England Journal of Medicine by researchers from Yale University School of Medicine in Connecticut.

This is good news. Medical groups are now one step closer to treating this form of dementia. However, there are still multiple unanswered questions.

Although lecanemab has shown less cognitive and functional decline in patients, longer trials are needed to evaluate the efficacy and safety of the drug in early Alzheimer’s disease. Effective only in the early stages, that is, closer to the onset of the disease.

Alzheimer’s disease is a progressive brain disease that typically affects people in their mid-sixties. It rarely affects people under the age of 65 and is known as early-onset Alzheimer’s disease. Memory loss, confusion, disorientation and inability to create new memories are some of the symptoms of the disease.

Lecanemab is essentially an antibody that binds to clumps of protein called amyloid plaques and removes them from the brain. Experimental drugs attach to amyloid proteins, attracting immune cells to break them down. These protein plaques are commonly found between neurons in the brain and have long been known to be a major cause of disease.

The study was conducted in 1,795 patients aged 50 to 90 years with early Alzheimer’s who presented with symptoms of only mild cognitive impairment over 18 months.

Lecanemab infusions were administered every 2 weeks to half of the participants (898) and placebo to the other half (897) throughout the study.

Almost 79 The proportion of participants in the study was Caucasian, 16.9 percent Asian, 12.9 percent Hispanic, and 2.6 percent Black.

This study was done through positron emission tomography (PET) imaging to understand amyloid load and cerebrospinal fluid testing to assess protein.

After the experiment, about 400 participants underwent brain scans to detect plaque changes.These showed 70% lower amyloid in people treated with lecanemab Scorewhile the control group score jumped 5%.

full of risks

While this is an important finding, it does not go very far in providing treatment for Alzheimer’s patients.The drug remains fraught with risks and has shown modest efficacy at best.

An 18-point rating scale, the Clinical Dementia Rating-Sum of Boxes, was used to measure differences in cognitive function between participants receiving lecanemab infusion and those receiving placebo. but it wasn’t that noticeable.

Those who received the drug only improved by 0.45 compared to those who did not, a difference of 27%.

This drug did not significantly reduce mortality. Of his 1,800 who participated in the study, his 0.7% who received lecanemab died compared to 0.8% of those who received a placebo injection during the study.

Japanese pharmaceutical company Eisai, which developed the investigational drug, claimed There were no deaths associated with it. They explained that other risk factors, such as comorbidities and anticoagulant therapy, may contribute to and be a possible reason for cerebral hemorrhage.

In addition, many adverse effects were also observed during the experiments.Participants’ brain scans showed sign Cerebral hemorrhage in 17% and brain swelling in 13%. Seven percent of those who received the drug had to discontinue it immediately because of these side effects.

Alzheimer’s disease is the most common dementia in the world. 2000000 suffering in India. There is currently no cure and prevention is the best option.

This is still the only promising result since aducanumab was approved after it was approved by the FDA in 2021. opposed It has been described by many scientists as causing amyloid-related imaging abnormalities such as cerebral edema and cerebral hemorrhage.

Also read: Nature study shows how a zap to the brain can improve memory in older people