CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI

Eligibility criteria

Inclusion Criteria:
1. 65+ years old, male or female
2. Amyloid positivity as assessed by either PET, CSF, or plasma.
3. Qualify for an MCI Diagnosis.
4. Study partner available for informant measures.
5. Willing and able to undergo a brain MRI.
6. If currently on AD or sleep medications, must be at the same stable dose(s) for at least 3 weeks prior to screening and throughout the course of the study, and must continue to be under the care of their treating neurologist through the duration of the study.
7. Be able and willing to wear an Attune device during treatments
8. Able to sign informed consent in accordance with local regulations.
9. Be able to speak, read, and understand the language of the trial staff and the informed consent form.
10. Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.
11. Be able to adhere to the stimulation protocol and visit schedules.
12. Be medically stable at baseline/randomization as assessed by medical history and non-significant clinical results of safety labs and vital signs examination.
Exclusion Criteria:
1. Early-onset Alzheimer's disease, as defined by a diagnosis occurring prior to age 65.
2. Clinically significant depression, as defined by a score of >10 on the Geriatric Depression Scale
3. Moderate to severe untreated obstructive sleep apnea, as defined by an Apnea-Hypopnea Index (AHI) ≥ 15.
4. Has other medical or psychiatric symptoms or conditions that, in the opinion of the investigator, will interfere with study activities or confound interpretation of study results.
5. Is on medication which, in the opinion of the investigator, will confound study results.
6. Has a history of deep brain stimulation or ablative surgery
7. Has a history of substance abuse including alcohol use disorder in the past 6 months
8. Has a history of traumatic brain injury
9. Has any contraindications for completing a brain MRI scan.
   a. The subject's head must fit within the head coil.
10. Has an uncontrolled medical condition which may impact study results.
11. Is or has an immediate family member of staff directly involved with this trial.

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 2026-10-14