Study Questions Efficacy of New Alzheimer's Drug; Experts Cite Flawed Analysis Methods
A meta-analysis of seven Alzheimer's drugs, including Lecanemab, has questioned their clinical benefit, finding minimal impact on cognitive decline despite amyloid plaque removal, and noting safety risks like brain edema and hemorrhage. Experts suggest the study's methodology may obscure real treatment advancements.
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- 📰 Published: April 20, 2026 at 17:39
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(CNA reporter Zeng Yining, Taipei, April 20) A research team from Italy and multiple other countries compiled and analyzed the clinical trial results of seven Alzheimer's drugs, publishing a paper questioning the help provided by anti-amyloid drugs to patients. Domestic experts believe that its research analysis methods have flaws and may obscure the progress of treatment technology.
The prevalence of dementia among elderly Taiwanese aged 65 and above is about 8%, of which Alzheimer's disease accounts for more than half. In Alzheimer's patients, amyloid-beta (Aβ) protein accumulates in the brain, forming plaques and damaging nerve cells. In past drug development, researchers hoped to use anti-amyloid drugs for marking and clearing plaques through immune responses, but this needs to be started during the mild cognitive impairment stage.
A research paper published on April 16 in the Cochrane Database of Systematic Reviews by a research team from the Bologna Neuroscience Institute in Italy and multiple other countries, compiled and analyzed data from 17 clinical trials involving seven different drugs and over 20,000 participants, to explore the benefits of new anti-amyloid drugs for patients.
Zheng Han-ruo, associate professor at the Institute of Brain Science, Yang Ming Chiao Tung University, explained that this is a "Meta-analysis" primarily evaluating whether anti-amyloid antibody drugs help and are safe for patients. Although these drugs have been approved in some countries, their clinical practical benefits remain controversial.
Zheng Han-ruo pointed out that this paper reviewed 17 clinical trials covering seven different drugs. The analysis results show that these drugs can indeed effectively remove amyloid proteins from the brain, but for the decline in cognitive function and dementia severity, although there may be minor statistical differences, patients or their families can hardly feel a significant difference in daily life. Moreover, there are significant safety risks, such as brain edema and cerebral hemorrhage.
Zheng Han-ruo said that the treatment process with these drugs requires frequent brain imaging examinations, and coupled with the high drug prices, it is a huge burden for patients' families and the medical system. This phenomenon of "pathological improvement, but symptoms remain" challenges the "amyloid hypothesis," according to the paper's authors, and does not support the use of these drugs as routine first-line therapy for dementia.
However, Fu Zhong-ling, deputy director of the Department of Neurology at Taipei Veterans General Hospital, pointed out that when patients' symptoms are very mild, they can already achieve near-perfect scores in the tests used in this study. Even if the drugs truly work, the scales cannot reflect more refined progress.
Fu Zhong-ling stated that this report may overemphasize the "group average" of different generations of drugs and their performance in different participants, while neglecting whether certain patients with "successful plaque clearance" have gained far-above-average benefits, thus potentially masking the progress of current treatment technology.
Wang Pei-ning, director of Yisen Clinic and attending physician in neurology at Taipei Veterans General Hospital, believes that the core design of this research cannot truly answer the question of "whether clinical improvement occurs after amyloid clearance." Coupled with fundamental flaws in classification and analysis methods, it cannot provide a convincing conclusion on the efficacy of anti-amyloid antibody drugs.
Regarding the risks of brain edema and cerebral hemorrhage, Zheng Han-ruo said that research in actual medical practice shows that the risk of brain edema or cerebral hemorrhage in Asians may be lower than in Caucasians. Therefore, patients do not need to panic excessively, as long as they discuss thoroughly with their doctors and undergo regular examinations as recommended. (Editor: Wu Su-rou) 1150420
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Keywords:
The prevalence of dementia among elderly Taiwanese aged 65 and above is about 8%, of which Alzheimer's disease accounts for more than half. In Alzheimer's patients, amyloid-beta (Aβ) protein accumulates in the brain, forming plaques and damaging nerve cells. In past drug development, researchers hoped to use anti-amyloid drugs for marking and clearing plaques through immune responses, but this needs to be started during the mild cognitive impairment stage.
A research paper published on April 16 in the Cochrane Database of Systematic Reviews by a research team from the Bologna Neuroscience Institute in Italy and multiple other countries, compiled and analyzed data from 17 clinical trials involving seven different drugs and over 20,000 participants, to explore the benefits of new anti-amyloid drugs for patients.
Zheng Han-ruo, associate professor at the Institute of Brain Science, Yang Ming Chiao Tung University, explained that this is a "Meta-analysis" primarily evaluating whether anti-amyloid antibody drugs help and are safe for patients. Although these drugs have been approved in some countries, their clinical practical benefits remain controversial.
Zheng Han-ruo pointed out that this paper reviewed 17 clinical trials covering seven different drugs. The analysis results show that these drugs can indeed effectively remove amyloid proteins from the brain, but for the decline in cognitive function and dementia severity, although there may be minor statistical differences, patients or their families can hardly feel a significant difference in daily life. Moreover, there are significant safety risks, such as brain edema and cerebral hemorrhage.
Zheng Han-ruo said that the treatment process with these drugs requires frequent brain imaging examinations, and coupled with the high drug prices, it is a huge burden for patients' families and the medical system. This phenomenon of "pathological improvement, but symptoms remain" challenges the "amyloid hypothesis," according to the paper's authors, and does not support the use of these drugs as routine first-line therapy for dementia.
However, Fu Zhong-ling, deputy director of the Department of Neurology at Taipei Veterans General Hospital, pointed out that when patients' symptoms are very mild, they can already achieve near-perfect scores in the tests used in this study. Even if the drugs truly work, the scales cannot reflect more refined progress.
Fu Zhong-ling stated that this report may overemphasize the "group average" of different generations of drugs and their performance in different participants, while neglecting whether certain patients with "successful plaque clearance" have gained far-above-average benefits, thus potentially masking the progress of current treatment technology.
Wang Pei-ning, director of Yisen Clinic and attending physician in neurology at Taipei Veterans General Hospital, believes that the core design of this research cannot truly answer the question of "whether clinical improvement occurs after amyloid clearance." Coupled with fundamental flaws in classification and analysis methods, it cannot provide a convincing conclusion on the efficacy of anti-amyloid antibody drugs.
Regarding the risks of brain edema and cerebral hemorrhage, Zheng Han-ruo said that research in actual medical practice shows that the risk of brain edema or cerebral hemorrhage in Asians may be lower than in Caucasians. Therefore, patients do not need to panic excessively, as long as they discuss thoroughly with their doctors and undergo regular examinations as recommended. (Editor: Wu Su-rou) 1150420
Stand with the facts. Your every sponsorship is a force for protecting press freedom.
Download the CNA "First News" APP to grasp the latest news in real-time.
Text, images, and audio/video on this website may not be reproduced, broadcast, or transmitted without authorization.
Keywords: