NCT05997030 · RECRUITING
Low-Intensity Focused Ultrasound (LIFU) Neuromodulation
This trial is testing whether low-intensity focused ultrasound, a non-invasive device that sends gentle sound waves into the brain, is safe and tolerable for people with mild cognitive impairment due to Alzheimer's disease. It is a very early feasibility study, meaning the only goal right now is to establish that the procedure does not cause harm. It is not yet testing whether it actually helps cognition.
You may qualify if
- 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
You're excluded if
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-11-24