Ultrasonic Neuromodulation for Treatment of Cognitive Impairment

NCT06135051 | Terminated Phase 1

• 1 other identifier: IRB_00173042
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Dementia; Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• Montreal Cognitive Assessment Test for Dementia (MoCA)

  The MoCA is a 30-point test to detect cognitive impairment. Scores range from 0 (poor) and 30 (perfect).

  Up to 3 months following study initiation

• Hamilton Depression Rating Scale (HDRS-17)

  This 17-item questionnaire rates the severity of depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The scores range from 0 (no symptoms) to 52 (worst possible).

  Up to 3 months following study initiation

• Amyloid PET

  PET (positron emission tomography) combined with fluorine-18 labelled radiotracers provide brain scans that are interpreted as either amyloid-beta positive or negative.

  Up to 3 months following study initiation

Secondary Outcomes (3)

• Hopkins Verbal Learning Test-Revised (HVLT-R)

  Up to 3 months following study initiation

• Digit Span Memory Test

  Up to 3 months following study initiation

• Trail Making Test, Part A and B

  Up to 3 months following study initiation

Study Arms (2)

Active stimulation

EXPERIMENTAL

Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by Alzheimer's disease.

Device: Diadem prototype

Sham stimulation

SHAM COMPARATOR

Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses.

Device: Diadem prototype

Interventions

Diadem prototype DEVICE

The device delivers low-intensity ultrasonic waves into specific brain targets.

Active stimulation; Sham stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mild cognitive impairment or mild dementia due to Alzheimer's disase (AD) with confirmed AD biomarkers (Amyloid PET or CSF)
• Age 65-80
• MOCA \> 18

You may not qualify if:

• Evidence of cerebral amyloid angiopathy or stroke within 1 year
• Clinical symptoms or findings suggestive of alternative diagnosis or co-pathology
• Inability to complete MRI
• Suicidal ideation

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: August 18, 2024
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)