Ultrasonic Neuromodulation for Treatment of Cognitive Impairment

Alzheimer Disease Clinical Trial

Official title:

Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Cognitive Impairment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06135051
• Other study ID #: IRB_00173042
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2024
• Est. completion date: April 2027

Study information

• Verified date: November 2023
• Source: University of Utah
• Contact: Jan Kubanek, PhD
• Phone: 801-213-1418
• Email: jan.kubanek[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia

Intervention

Device:
• Diadem prototype
The device delivers low-intensity ultrasonic waves into specific brain targets.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Hopkins Verbal Learning Test-Revised (HVLT-R)	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)).	Up to 3 months following study initiation
Secondary	Digit Span Memory Test	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.	Up to 3 months following study initiation
Secondary	Trail Making Test, Part A and B	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.	Up to 3 months following study initiation