Ultrasonic Neuromodulation for Treatment of Cognitive Impairment

Utah System of Higher Education (USHE)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Alzheimer Disease; Cognitive Impairment; Dementia

Treatments: Device: Diadem prototype

Study type: Interventional

Funder types: Other

Identifiers

NCT06135051

IRB_00173042

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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1 participants in 2 patient groups

Active stimulation

Experimental group

Description:

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

Treatment:

Device: Diadem prototype

Sham stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Diadem prototype