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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1
The device delivers low-intensity ultrasonic waves into specific brain targets.
University of Utah
Salt Lake City, Utah, United States
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).
Time frame: 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).
Time frame: 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.
Time frame: Up to 3 months following study initiation
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)).
Time frame: Up to 3 months following study initiation
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.
Time frame: Up to 3 months following study initiation
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.
Time frame: Up to 3 months following study initiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.