RecruitingNot ApplicableNCT05997030

Low-Intensity Focused Ultrasound (LIFU) Neuromodulation

Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

Sponsor

Ali Rezai

Enrollment

15 participants

Start Date

Oct 12, 2023

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease

Summary

This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with mild cognitive impairment ( MCI) due to Alzheimer's disease.

Eligibility

Min Age: 45 YearsMax Age: 85 Years

Inclusion Criteria5

Males and non-pregnant females, aged 45-85 years
Able and willing to give informed consent
Must meet the clinical criteria for MCI due to Alzheimer's disease
If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable dose for at least 45 days
Able to communicate sensations during the LIFU procedure

Exclusion Criteria6

Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia).
Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain.
Participants with a history of seizure disorder.
Participants with clinically significant chronic pulmonary disorders e.g., severe emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
Participant does not speak English
Participant is pregnant or planning to be pregnant