| 論文種別 | 原著(症例報告除く) |
| 言語種別 | 英語 |
| 査読の有無 | その他(不明) |
| 表題 | Baseline characteristics of patients with early Alzheimer's disease enrolled in the pivotal trial of low-intensity pulsed ultrasound (LIPUS-AD). |
| 掲載誌名 | 正式名：Journal of Alzheimer's disease reports 略 称：J Alzheimers Dis Rep ISSNコード：25424823/25424823 |
| 掲載区分 | 国外 |
| 巻・号・頁 | 9,pp.25424823251407541 |
| 著者・共著者 | Hiroaki Shimokawa, Masahiro Akishita, Takashi Asada, Sadao Katayama, Yorito Hattori, Yusuke Yakushiji, Yasuyuki Taki, Hiroyuki Murai, Youshun Boku, Masashi Tsujimoto, Hiroyuki Umegaki, Tomoko Ogawa, Shoya Matsumoto, Kenjiro Ono, Yukari Imon, Taiji Tsunemi, Atsushi Iwata, Ritsuko Hanajima, Shin Hisahara, Taira Uehara, Takanobu Ishiguro, Yuriko Nakaoku, Kenji Ishii, Aiko Ishiki, Yoji Nagai, Satoshi Teramukai, Masafumi Ihara, Masanori Fukushima |
| 発行年月 | 2025/12 |
| 概要 | BACKGROUND:We demonstrated that low-intensity pulsed ultrasound (LIPUS) therapy tended to ameliorate cognitive declines in patients with early Alzheimer's disease (AD) in the pilot trial. Thus, we have started the pivotal trial in a randomized, double-blind, placebo-controlled manner (LIPUS-AD).OBJECTIVE:We here report the clinical characteristics of AD patients enrolled in the trial.METHODS:The major inclusion criteria included age 50-90 years of both sex, Clinical Dementia Rating (CDR) global score of 0.5∼1.0 and Japanese version of the Mini-Mental State Examination (MMSE-J) score greater than 20 at screening, positive brain Aβ-PET, and no symptomatic brain hemorrhage, infarction, or edema on brain MRI.RESULTS:A total of 231 subjects were finally enrolled. As compared with the pilot trial, they were characterized by older age and higher prevalence of dyslipidemia. They had lower scores of ADAS-J-cog and Modified Hachinski Ischemic Scale (MHIS), while other cognitive scores were comparable with the pilot trial. Use of cholinesterase inhibitors was less as compared with the pilot trial. APOE ε4 polymorphism is present in 58% of the subjects, including heterozygote in 44% and homozygote in 14%. Brain MRI measurements showed that hippocampus volume was distributed with a peak at 5700-5999 mm3 without left and right difference, and brain Aβ-PET showed that centiloid scale distributed with a peak at 90-99.9 and standardized uptake value ratio (SUVR) with a peak at 0.7-0.79. There were weak but significant correlations between ADAS-J-cog14 and those brain MRI and Aβ-PET measurements.CONCLUSIONS:Clinical characteristics of subjects in the LIPUS-AD trial largely mimic those in the pilot trial, addressing efficacy and safety of the LIPUS therapy in early AD.Clinical Trial Gov. No.: NCT05983575, jRCT No.: jRCT2032230125. |
| DOI | 10.1177/25424823251407541 |
| PMID | 41477670 |