A Pilot Study of Whole-Brain Low-Intensity Pulsed Ultrasound Therapy for Early Stage of Alzheimer’s Disease (LIPUS-AD): A Randomized, Double-Blind, Placebo-Controlled Trial

• DOI: 10.1620/tjem.2022.j078
• Publication Date: 2022-09-14T22:10:12Z
• Authors: Hiroaki Shimokawa; Tomohiko Shindo; Aiko Ishiki; Naoki Tomita; Sadamitsu Ichijyo; Tasuku Watanabe; Takashi Nakata; Kumiko Eguchi; Yoku Kikuchi; Takashi Shiroto; Jun Takahashi; Satoshi Yasuda; Hiroyuki Arai
• Keywords: Clinical endpoint; Extracorporeal shockwave therapy

The prevalence of Alzheimer's disease (AD) has been rapidly increasing worldwide. We have developed a novel angiogenic therapy with low-intensity pulsed ultrasound (LIPUS), which is effective and safe in animal models AD vascular dementia. performed two trials LIPUS for (mild cognitive impairment due to mild AD); roll-in open trial safety, randomized, double-blind, placebo-controlled (RCT) efficacy safety. was whole brain through the bilateral temporal bones one hour 3 times week as session under special conditions (1.3 MPa, 32 cycles, 5% duty cycle) we identified. trial, 6 sessions RCT 3-month intervals 1.5 years. primary endpoint ADAS-J cog scores. terminated prematurely COVID-19 pandemic. In (N = 5), no adverse effects were noted. 22), worsening scores tended be suppressed group compared placebo at 72 (P 0.257). When responders defined those 72, 50% (5/10) 0% (0/5) groups, respectively 0.053). No These results suggest that tends suppress although next pivotal large number subjects warranted.