Evidence map›Paper›PMID 41477670›Full record

ArticleJournal of Alzheimer's disease reports

Baseline characteristics of patients with early Alzheimer's disease enrolled in the pivotal trial of low-intensity pulsed ultrasound (LIPUS-AD).

Hiroaki Shimokawa, Masahiro Akishita, Takashi Asada, Sadao Katayama, Yorito Hattori, Yusuke Yakushiji, Yasuyuki Taki, Hiroyuki Murai, Youshun Boku, Masashi Tsujimoto and 18 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of Alzheimer's disease reports. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05983575 (A Study to Evaluate the Efficacy and Safety of LIPUS-Brain Transcranial Low-intensity Pulsed-wave Ultrasound Device in Patients With Early Alzheimer's Disease), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05983575 phase3active not recruitingnot on this map

A Study to Evaluate the Efficacy and Safety of LIPUS-Brain Transcranial Low-intensity Pulsed-wave Ultrasound Device in Patients With Early Alzheimer's Disease

TypeinterventionalSponsorSound Wave Innovation CO., LTD.Ran2023 to 2026Enrolled220ConditionsAlzheimer Disease, Early OnsetArmsLIPUS-Brain, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Hiroaki ShimokawaSound Wave Innovation, Co, Ltd, Tokyo, Japan.ORCID https://orcid.org/0000-0001-7534-4826
Masahiro AkishitaTokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan.
Takashi AsadaMemory Clinic Ochanomizu, Tokyo, Japan.
Sadao KatayamaKatayama Clinic, Kurashiki, Japan.
Yorito HattoriNational Cerebral and Cardiovascular Center, Suita, Japan.ORCID https://orcid.org/0000-0002-1495-4433
Yusuke YakushijiKansai Medical University, Hirakata, Japan.
Yasuyuki TakiTohoku University, Sendai, Japan.
Hiroyuki MuraiInternational University of Health and Welfare Narita Hospital, Narita, Japan.
Youshun BokuMemory Clinic Toride, Toride, Japan.
Masashi TsujimotoNational Center for Geriatrics and Gerontology, Obu, Japan.
Hiroyuki UmegakiNagoya University Graduate School of Medicine, Nagoya, Japan.
Tomoko OgawaInternational University of Health and Welfare Hospital, Nasu-Shiobara, Japan.
Shoya MatsumotoThe University of Tokyo, Tokyo, Japan.
Kenjiro OnoKanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.ORCID https://orcid.org/0000-0001-8454-6155
Yukari ImonImon Yukari Neurology Clinic, Hiroshima, Japan.
Taiji TsunemiJuntendo University, Tokyo, Japan.
Atsushi IwataTokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan.
Ritsuko HanajimaTottori University, Yonago, Japan.
Shin HisaharaSapporo Medical University, Sapporo, Japan.
Taira UeharaFukuoka Sanno Hospital, Fukuoka, Japan.
Takanobu IshiguroNiigata University, Niigata, Japan.ORCID https://orcid.org/0000-0002-8205-4912
Yuriko NakaokuNational Cerebral and Cardiovascular Center, Suita, Japan.
Kenji IshiiTokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan.
Aiko IshikiTohoku Medical and Pharmaceutical University, Sendai, Japan.
Yoji NagaiKyoto University, Kyoto, Japan.
Satoshi TeramukaiKyoto Prefectural University of Medicine, Kyoto, Japan.
Masafumi IharaNational Cerebral and Cardiovascular Center, Suita, Japan.ORCID https://orcid.org/0000-0002-7102-4048
Masanori FukushimaLearning Health Society Institute, Nagoya, Japan.ORCID https://orcid.org/0000-0002-5456-3891

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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. 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.

Indexed as

Alzheimer's diseasecerebrovascular diseaseclinical trials/studiesnon-pharmacological interventions

Identifiers

PMID41477670
PMCPMC12748502

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.