{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,29]],"date-time":"2025-12-29T17:47:56Z","timestamp":1767030476314,"version":"3.48.0"},"reference-count":36,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Fiducia Co. Ltd., Tokyo, Japan"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Alzheimer's Disease Reports"],"published-print":{"date-parts":[[2025,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>We here report the clinical characteristics of AD patients enrolled in the trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The major inclusion criteria included age 50\u201390 years of both sex, Clinical Dementia Rating (CDR) global score of 0.5\u223c1.0 and Japanese version of the Mini-Mental State Examination (MMSE-J) score greater than 20 at screening, positive brain A\u03b2-PET, and no symptomatic brain hemorrhage, infarction, or edema on brain MRI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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.\n                      <jats:italic toggle=\"yes\">APOE<\/jats:italic>\n                      \u03b54 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\u20135999\u2005mm\n                      <jats:sup>3<\/jats:sup>\n                      without left and right difference, and brain A\u03b2-PET showed that centiloid scale distributed with a peak at 90\u201399.9 and standardized uptake value ratio (SUVR) with a peak at 0.7\u20130.79. There were weak but significant correlations between ADAS-J-cog14 and those brain MRI and A\u03b2-PET measurements.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                    <jats:p>Clinical Trial Gov. No.: NCT05983575, jRCT No.: jRCT2032230125<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/25424823251407541","type":"journal-article","created":{"date-parts":[[2025,12,29]],"date-time":"2025-12-29T17:43:03Z","timestamp":1767030183000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Baseline characteristics of patients with early Alzheimer's disease enrolled in the pivotal trial of low-intensity pulsed ultrasound (LIPUS-AD)"],"prefix":"10.1177","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7534-4826","authenticated-orcid":false,"given":"Hiroaki","family":"Shimokawa","sequence":"first","affiliation":[{"name":"Sound Wave Innovation, Co, Ltd"},{"name":"Tohoku University Graduate School of Medicine, Sendai, Japan"},{"name":"International University of Health and Welfare, 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