by Kim Jonghwa
Published 16 Apr.2026 14:59(KST)
A large-scale validation study has found that a dementia drug, once hailed as a "beacon of hope" for early Alzheimer's disease treatment, failed to bring about noticeable improvements that patients and their families could actually feel. Although the drug reduced amyloid beta, which has been identified as a key culprit in the brain, it did not significantly slow the rate of memory decline. Furthermore, the risk of side effects such as brain swelling or small brain hemorrhages increased.
Reference photo to aid understanding of the article. Courtesy of Getty Images Bank and Yonhap News Agency
원본보기 아이콘A joint research team from IRCCS in Bologna, Italy, and collaborators from Switzerland and the Netherlands reached this conclusion in a Cochrane Review that re-analyzed data from 17 clinical trials involving 20,342 patients with mild cognitive impairment or early Alzheimer's disease. The findings were published in the Cochrane Database of Systematic Reviews on April 16, 2026. The Cochrane Review is considered one of the most authoritative and comprehensive analyses in the medical field, as it consolidates and re-examines the results of multiple clinical trials.
The analysis revealed that while dementia drugs targeting amyloid beta in the brain showed only a very slight difference in test results, the actual changes experienced by patients or their families in daily life-such as feeling that symptoms were "a bit less severe"-were minimal or virtually nonexistent.
The researchers emphasized that the risk of side effects (ARIA), such as brain swelling or small hemorrhages, increased significantly in the drug-treated group. While many of these side effects were detected only through brain imaging methods like MRI, the long-term effects remain unclear.
These findings are likely to reignite debate over whether newly approved dementia drugs, such as Lecanemab and Donanemab, truly protect patients' memory and daily life, even though they reduce the buildup of waste proteins in the brain.
Robert Howard, Professor of Old Age Psychiatry at University College London (UCL), interpreted these results as a "correction to the overinflated expectations" for dementia drugs. He noted, "Large-scale clinical trials can detect even the smallest differences numerically, but these may not translate to changes that patients and families actually perceive." He evaluated the review as an important step in tempering overly optimistic expectations that had been communicated previously.
In particular, Professor Howard dismissed the hope that longer-term treatment would yield greater effects. He pointed out that even after three years of long-term tracking, there was no clear difference between early and delayed treatment groups, making it difficult to consider these drugs as fundamental treatments that alter the course of the disease itself.
South Korean experts have also evaluated these findings as a case where concerns raised at the time of U.S. Food and Drug Administration (FDA) approval have become reality. Changjun Lee, Director of the Memory and Glial Cell Research Group at the Institute for Basic Science (IBS), told the Korea Science Media Center (SMCK), "From the time Lecanemab was first approved, its effects were somewhat exaggerated," adding, "This paper reconfirms those limitations with actual clinical data."
Director Lee especially emphasized the issue of side effects. He explained, "ARIA, or brain swelling, is not just an imaging finding; it is a serious side effect that could further worsen neuroinflammation, which has recently been highlighted as a cause of Alzheimer's." He pointed out, "Simply targeting amyloid is not enough; we need treatment strategies that also address inflammation and neural cell damage."
This review suggests that the development of dementia treatments should expand from targeting only amyloid to more comprehensive, personalized approaches that address multiple causes. In South Korea as well, research on blood biomarkers, neuroinflammation, and gene-based personalized therapies is expected to become increasingly important.
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