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NCT06135051
Ultrasonic Neuromodulation for Treatment of Cognitive Impairment
Phase 1, PHASE2 trial testing Diadem prototype in Alzheimer Disease in 1 participant. Terminated before completion.
21 August 2024
Quick facts
| Lead sponsor | University of Utah |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 18 August 2024 |
| Primary completion | 21 August 2024 |
| Estimated completion | 21 August 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Diadem prototype
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
- Dementia — all drugs for Dementia →
- Cognitive Impairment — all drugs for Cognitive Impairment →
Sponsor
University of Utah
Who can join
Adults 18 to 80, any sex, with Alzheimer Disease or Dementia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will evaluate a new form of non-invasive deep brain therapy for individuals with Alzheimer's disease. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging, PET imaging, and numerical scales of cognitive performance.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Current state of clinical ultrasound neuromodulation.
Matt E, Radjenovic S, Mitterwallner M, Beisteiner R. · · 2024 · cited 27× · PMID 38962179 · DOI 10.3389/fnins.2024.1420255 -
Low-intensity transcranial ultrasound neuromodulation promotes neuronal regeneration: A new hope for noninvasive treatment of neurodegenerative diseases.
Xia S, He C, Li Y, Li H, et al · · 2026 · cited 1× · PMID 40817729 · DOI 10.4103/nrr.nrr-d-25-00113
Verify or expand the search:
- PubMed search for NCT06135051
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Utah trials
Trials by the same sponsor.
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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 NCT06135051 (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 University of Utah
- Last refreshed: 25 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/NCT06135051.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing