New Alzheimer drug slows cognitive decline by 27 pc, raises treatment hopes

Tribune News Service

Aditi Tandon

New Delhi, September 28

A new drug for Alzheimer disease has shown great promise by reducing cognitive decline in people with early signs of the disease by about 27 per cent.

Announcing the results of a much awaited trial today, Japanese pharmaceutical firm Eisai and US biotechnology giant Biogen said the study had enrolled 1,795 people with early Alzheimer’s disease and amyloid beta in the brain and the trial participants were divided into two groups—a group that received 10 mg per kg dose once every two weeks for 18 months and another group that was pn placebo.

"Lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale compared with placebo at 18 months by 27 per cent,” Eisai announced.

The new drug, Lecanemab, targeted amyloid beta in the brains of patients with mild cognitive impairment due to Alzheimer’s disease and mild Alheimer’s disease with confirmed presence of amyloid pathology in the brain.

The amyloid-beta precursor protein, found in the brains of patients with Alzheimer’s disease, is a large membrane protein that normally plays an essential role in neural growth and repair. However, later in life, a corrupted form can destroy nerve cells, leading to the loss of thought and memory in Alzheimer’s disease.

Terming the results from Clarity Alzheimer’s Disease clinical trial of lecanemob as the most encouraging results in clinical trials treating the underlying causes of Alzheimer’s to date, the Alzheimer’s Association today said, “On behalf of the more than 6 million Americans living with Alzheimer’s disease and their families, the Alzheimer’s Association enthusiastically welcomes the positive topline data reported today by Eisai and Biogen on the CLARITY AD global Phase 3 clinical trial of lecanemab.”

The association added that for people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way.

"These results indicate lecanamab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions. Treatments that deliver these benefits to those with mild cognitive impairment (MCI) due to Alzheimer’s disease and early Alzheimer’s dementia are just as valuable as treatments that extend the lives of those with other terminal diseases,” the association said welcoming the results.

The future could be promising with Eisai saying it will discuss the data with regulatory authorities in the US, Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of Eisai’s FY2022, which ends March 31, 2023.

Additionally, Eisai will present the Clarity AD study results on November 29, 2022, at the Clinical Trials on Alzheimer’s Congress (CTAD), and publish the findings in a peer-reviewed medical journal.

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