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NCT06135051

Ultrasonic Neuromodulation for Treatment of Cognitive Impairment

Terminated Phase 1, PHASE2 Last updated 25 May 2025
What this trial tests

Phase 1, PHASE2 trial testing Diadem prototype in Alzheimer Disease in 1 participant. Terminated before completion.

Timeline
18 August 2024
Primary endpoint
21 August 2024
21 August 2024

Quick facts

Lead sponsorUniversity of Utah
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingtriple
Primary purposetreatment
Enrollment1
Start date18 August 2024
Primary completion21 August 2024
Estimated completion21 August 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other trials of Diadem prototype

Trials testing the same drug.

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other University of Utah trials

Trials by the same sponsor.

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Data sources for this page

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