Safety and Feasibility Trial of Ultrasonic Debris Clearance to Promote Brain Resilience
This pilot study will evaluate the safety, tolerability, and feasibility of Ultrasonic Debris Clearance (UDC), a noninvasive low-intensity focused ultrasound intervention, in amyloid-positive adults who are asymptomatic but at risk for Alzheimer's disease, or who have mild cognitive impairment or mild dementia. The study is designed to test whether repeated UDC sessions can be delivered safely and feasibly in this population, while also exploring efficacy via biomarkers and clinical measures.
• 1. Physician-reported amyloid positivity diagnosed by amyloid positron emission tomography (PET) OR historic CSF positivity of Abeta42, total tau, or phosphorylated tau OR positivity of plasma pTau-217.
• 2. Age ≥ 18 years. No gender/sex, racial, or ethnic preference. Subjects greater than 60 years of age will be assumed to be non-pregnant based on age and expected post-menopausal status. Female subjects under the age of 60 will complete a two-step assessment of pregnancy status (a self-reported assessment of menopause that proceeds to a urine human chorionic gonadotropin (hCG) test to confirm non-pregnancy, if the participant is not post-menopausal).
• 3. CDR Scale score less than or equal to 1.0, consistent with mild, very mild, or no dementia.
• 4. Ability and willingness to comply with the study procedures (six sessions sitting in a procedure chair for up to one hour for the procedure, with an ultrasound device placed on their scalp; additional time for the MRI assessment, blood draws, and cognitive assessments).
• 5. Ability to understand and the willingness to sign a written informed consent document.