Ultrasonic Neuromodulation for Treatment of Cognitive Impairment

Phase 1

Terminated

• Conditions: Dementia; Cognitive Impairment; Alzheimer Disease

• Registration Number: NCT06135051
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-11
• Study First Posted: 2023-11-18
• Study Start: 2024-08-18
• Primary Completion: 2024-08-21
• Study Completion: 2024-08-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment Test for Dementia (MoCA)	Up to 3 months following study initiation	The MoCA is a 30-point test to detect cognitive impairment. Scores range from 0 (poor) and 30 (perfect).
Hamilton Depression Rating Scale (HDRS-17)	Up to 3 months following study initiation	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).
Amyloid PET	Up to 3 months following study initiation	PET (positron emission tomography) combined with fluorine-18 labelled radiotracers provide brain scans that are interpreted as either amyloid-beta positive or negative.

Secondary Outcome Measures

Name	Time	Method
Hopkins Verbal Learning Test-Revised (HVLT-R)	Up to 3 months following study initiation	HVLT-R is a verbal memory test with 12 words learned over three trials, with the correct words summed for the Total Recall score (range = 0 (worst) - 36 (best)). The Delayed Recall score is the number of correct words recalled after a 20 - 25-minute delay (range = 0 (worst) - 12 (best)).
Digit Span Memory Test	Up to 3 months following study initiation	A standard test for working memory. In this test, a list of random numbers or letters is presented on a computer screen at the rate of one per second. The test begins with three numbers, increasing until the person commits errors. The average digit span for normal adults without error is seven plus or minus two. The higher the number, the more patent the working memory.
Trail Making Test, Part A and B	Up to 3 months following study initiation	The test probes visual scanning and working memory. The task is to connect a set of 25 dots as quickly as possible while maintaining accuracy. The faster the completion of Part A and Part B, the better.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States