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NCT05983575
A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease
Phase 3 trial testing LIPUS-Brain in Alzheimer Disease, Early Onset in 220 participants. Participants enrolled and being followed up; not accepting new ones.
31 January 2026
Quick facts
| Lead sponsor | Sound Wave Innovation CO., LTD. |
|---|---|
| Phase | Phase 3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 220 |
| Start date | 31 October 2023 |
| Primary completion | 31 January 2026 |
| Estimated completion | 31 July 2026 |
| Sites | 19 locations across Japan |
Drugs / interventions tested
- LIPUS-Brain
- Placebo
Conditions studied
- Alzheimer Disease, Early Onset — all drugs for Alzheimer Disease, Early Onset →
Sponsor
Sound Wave Innovation CO., LTD.
Who can join
Adults 50 to 89, any sex, with Alzheimer Disease, Early Onset. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a multicenter, randomized, double-blinded, placebo-controlled Phase 3 study comparing LIPUS-Brain transcranial low-intensity pulsed-wave ultrasound device to placebo in patients with Early Alzheimer's Disease. The primary objective of the study is to assess changes in ADAS-J-cog-14 scores from baseline to 72 weeks.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Treatment of Alzheimer's Disease: Beyond Symptomatic Therapies.
Buccellato FR, D'Anca M, Tartaglia GM, Del Fabbro M, et al · · 2023 · cited 49× · PMID 37762203 · DOI 10.3390/ijms241813900 -
Pivotal trial of low-intensity pulsed ultrasound therapy for early Alzheimer's disease: Rationale and design.
Shimokawa H, Akishita M, Ihara M, Teramukai S, et al · · 2025 · cited 1× · PMID 40034530 · DOI 10.1177/25424823241312108 -
Baseline characteristics of patients with early Alzheimer's disease enrolled in the pivotal trial of low-intensity pulsed ultrasound (LIPUS-AD).
Shimokawa H, Akishita M, Asada T, Katayama S, et al · · 2025 · PMID 41477670 · DOI 10.1177/25424823251407541
Verify or expand the search:
- PubMed search for NCT05983575
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05983575 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sound Wave Innovation CO., LTD.
- Last refreshed: 15 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05983575.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing