New drug for Alzheimer's disease approved! Experts: Grasp the golden period of early diagnosis

"What victory can there be? Standing up means everything. ”

——This is a poem by the poet Rilke quoted by Hu Yong, a professor at the School of Journalism and Communication of Peking University, in his circle of friends. In April this year, an article titled "Peking University Professors Become 24-Hour Caregivers" swiped the screen, which once again focused the public's attention on Alzheimer's disease patients and caregivers.

According to the data of the China Alzheimer's Report 2022, the number of Alzheimer's patients in China has reached 13.14 million in 2019, making it the country with the largest number of Alzheimer's patients in the world, ranking first in the world. Alzheimer's disease is a heavy burden on individuals, families and society, and the importance of prevention and early treatment of Alzheimer's disease cannot be overstated.

At the beginning of this year, the official website of the State Food and Drug Administration announced that the marketing application submitted by Eisai for a new class of Alzheimer's disease drug lecanemab injection (Chinese trade name: Leyibao) was approved for the treatment of mild cognitive impairment caused by Alzheimer's disease and mild dementia of Alzheimer's disease. Lecanemab is also the first fully approved new drug for Alzheimer's disease by the US FDA in the past 20 years. Before it was officially approved, the drug had been implemented in Boao Lecheng, Hainan Province at the end of last year through the "first trial" policy.

What benefits can new drugs bring to Alzheimer's patients? Does it work for all people with Alzheimer's disease? In the "entanglement" with the disease for many years, to what extent do people understand the pathogenesis of Alzheimer's disease, and when will the disease be truly conquered? Focusing on the above topics, a reporter from Yangcheng Evening News interviewed Professor Liu Jun, director of the Department of Neurology of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine and head of the Hainan pilot project of lecanemab.

The first "cause-based therapy" targeted drug was launched

According to public information, Alzheimer's disease (AD), commonly known as "Alzheimer's disease", is a neurodegenerative disease with insidious onset and progressive development, and patients usually experience symptoms such as memory loss, weakened learning ability, impaired emotional regulation, and loss of exercise ability. Clinically, it is characterized by generalized dementia such as memory impairment, aphasia, apraxia, agnosia, impairment of visuospatial skills, executive dysfunction, and personality and behavior changes, and the etiology is still unknown.

"There are many theories about the etiology of AD, and the current mainstream hypothesis is the Aβ protein cascade hypothesis, that is, β amyloid is produced too much in the brain and is not cleared in time, resulting in a large number of deposition, leading to the death of neurons, which is also the main cause of dementia." Liu Jun introduced that based on the Aβ cascade hypothesis, designing drugs to target Aβ in the brain of patients, reduce Aβ production or promote Aβ clearance, so as to stop the progression of the disease, is one of the core ideas of new drug development for Alzheimer's disease in the world.

At the beginning of this year, the first new drug based on this hypothesis, lecanemab, was officially approved for marketing in China. According to reports, lecanemab is an anti-β oid amylin drug, and its principle is to delay the clinical process by removing toxic Aβ protein from the brain.

"For nearly two decades, there have been no new clinical treatments for Alzheimer's patients. The advent of lecanemab has opened up new ideas and directions, and also brought new opportunities for the treatment of AD. Liu Jun pointed out.

It is worth noting that before lecanemab was officially approved, the drug had also been implemented in Boao Lecheng through the pilot policy. "In December last year, the new drug was used in the Boao Branch of Hainan Hospital, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and so far, 89 patients have been treated with the new drug. Among them, several patients who have completed 6 months of treatment have shown a significant decrease in Aβ protein, and the feedback from the patient's family and myself is also very good, mainly because they are not easy to get lost, and their mood is much more stable. Liu Jun said that although there is still a gap between China and Europe and the United States in terms of new drugs, the policy, including "first trial, first trial", allows the people to use the latest therapies in a timely manner, and hopes that these valuable clinical data can bring new inspiration to the academic community and local pharmaceutical companies to promote the overall development of AD treatment in China.

New drugs are not suitable for all AD patients

Liu Jun introduced that lecanemab is not suitable for all Alzheimer's disease patients, and patients who are willing to use the drug need to undergo rigorous and detailed examination and evaluation, and must first determine whether they are amyloid positive β, which can usually be determined by peripheral blood or cerebrospinal fluid examination. During the medication, it is also necessary to do a good job of dynamic monitoring of imaging, among which, PET amyloid imaging can monitor the effect, and brain magnetic resonance can monitor whether there are adverse reactions such as microbleeding. The drug is not suitable for patients with intermediate and advanced stages and patients with contraindications, such as people with cerebral hemorrhage and cerebral edema, and patients using anticoagulants and antithrombotic drugs, the use of this drug may increase the risk of cerebral hemorrhage.

Currently, lecanemab is indicated in patients with mild disease in the early stages. The drug has not yet been included in the medical insurance, and the price after marketing is 2508 yuan/bottle, and the specification is 200mg(2ml)/bottle. According to this calculation, the recommended course of treatment for a patient weighing 60 kg is 18 months and costs about 200,000 yuan. The reporter learned that up to now, the drug has been prescribed in Shanghai, Xiamen, Guangzhou and other cities.

"According to the results of clinical studies, the earlier a patient is treated, the more likely it is that there is a chance of reversal." Liu Jun said.

However, correspondingly, the mainland public's awareness and action in the early diagnosis and treatment of Alzheimer's are generally insufficient, and it is easy to mistake the early symptoms of Alzheimer's for "old confusion", thus missing the "golden window period" of treatment, that is, the earlier preclinical stage of the mild cognitive impairment stage of the disease.

According to the "2023 Basic Data and Prevention and Control Strategies of Alzheimer's Disease in China" released by the Alzheimer's Disease Prevention and Control Association. It proposes that prevention must be put first and the concept of early prevention must be established; Establish a complete monitoring system for the morbidity and mortality of Alzheimer's disease and other dementia; Through active aging, advocating an active and healthy lifestyle, we will establish demonstration bases for the early prevention of Alzheimer's disease and other dementias in cities with a high degree of aging, and continuously summarize experience through pilot and follow-up studies, so as to establish a scientific Chinese strategy and plan for the early prevention of Alzheimer's disease and other dementias.

In this regard, Liu Jun especially reminded that AD is relatively hidden in the early stage, so young people should pay more attention to the elderly at home, and when they find that the elderly can't remember their names, they are always lost, and they have no clue about doing things, they can be brought to the hospital for examination in time to achieve early intervention and treatment. "The diagnosis of Alzheimer's disease can be completed within a week, mainly through peripheral blood, PET-CT, and cerebrospinal fluid examination. At the same time, scale scores are also crucial in the diagnosis of AD. Liu Jun said that the prevention and treatment of Alzheimer's disease is not only by drugs, but also very important to develop good living habits.

Reporter Chen Zeyun

Editor: Dong Pengcheng