NCT07866768Recruiting

CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI

Safety and Feasibility Study of ATTN201 Centromedian Nucleus of the Thalamus Focused Ultrasound Stimulation for Enhanced Glymphatic Clearance in Amyloid Positive Patients With Mild Cognitive Impairment

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn if a wearable ultrasound device, called ATTN201, is safe and easy to use. The study is for adults ages 65 and older who have mild cognitive impairment (MCI) and a buildup of a protein called amyloid in the brain. Amyloid buildup is an early sign of Alzheimer's disease. The ATTN201 device sends low-intensity sound waves to a deep area of the brain that helps control sleep. The aim is to boost deep-sleep brain waves. These brain waves may help the brain clear away waste, including amyloid. The main questions it aims to answer are: 1. What, if any, issues do participants have when using the ATTN201 device? 2. Can participants complete the full study schedule? Researchers will compare focused ultrasound to unfocused ultrasound. Unfocused ultrasound is a look-alike treatment. It feels and sounds the same but is not aimed at the brain target. The comparison will show if the focused treatment changes sleep brain waves, blood markers of Alzheimer's disease, or memory and thinking. Participants will: * Visit the study site for memory and thinking tests, blood draws, a health check, and MRI scans of the brain * Record their sleep at home for at least 5 days with a sleep diary, a watch-like sensor, and a headband that measures brain waves * Be assigned by chance to focused or unfocused ultrasound * Take part in 10 nap sessions over 2 weeks while wearing the device, at the study site or at home * Return for a final visit to repeat the first tests, and may return for an optional visit 3 months later

Status (registry): Recruiting
Study type: Interventional
Enrollment: 28 (estimated)
First submitted: 20 Aug 2026
Start date: Oct 2026
Primary completion date: Jan 2028
Lead sponsor: University of California, San Francisco
Diseases: Alzheimer disease
NCT number: NCT07866768

What you commit to

Study type: Interventional
Planned participants: 28
From Oct 2026 to the primary completion date, Jan 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Early-onset Alzheimer's disease, as defined by a diagnosis occurring prior to age 65.
Is on medication which, in the opinion of the investigator, will confound study results.

Other illness

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.
Has a history of deep brain stimulation or ablative surgery
Has a history of substance abuse including alcohol use disorder in the past 6 months
Has a history of traumatic brain injury
Has an uncontrolled medical condition which may impact study results.

Other

Clinically significant depression, as defined by a score of \>10 on the Geriatric Depression Scale
Moderate to severe untreated obstructive sleep apnea, as defined by an Apnea-Hypopnea Index (AHI) ≥ 15.
Has any contraindications for completing a brain MRI scan.
- The subject's head must fit within the head coil.
Is or has an immediate family member of staff directly involved with this trial.

Who the study is looking for

65+ years old, male or female
Amyloid positivity as assessed by either PET, CSF, or plasma.
Qualify for an MCI Diagnosis.
Study partner available for informant measures.
Willing and able to undergo a brain MRI.
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.
Be able and willing to wear an Attune device during treatments
Able to sign informed consent in accordance with local regulations.
Be able to speak, read, and understand the language of the trial staff and the informed consent form.
Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.
Be able to adhere to the stimulation protocol and visit schedules.
Be medically stable at baseline/randomization as assessed by medical history and non-significant clinical results of safety labs and vital signs examination.

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of California San Francisco Coordinator of this site? Confirm its status	San Francisco	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.