NCT07866768 · University of California, San Francisco
CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
ATTN201 Focused Ultrasound to the CMN
Low-intensity focused ultrasound delivered to the centromedian nucleus of the thalamus by the investigational ATTN201 head-worn device.
DEVICE
ATTN201 Unfocused Ultrasound
Unfocused ultrasound delivered by the same device, serving as the control condition.
Primary outcome measures
Incidence, Severity, and Relatedness of Adverse Events and Serious Adverse Events
Time frame: From informed consent through the 3-month follow-up visit (up to ~5 months)
Safety and tolerability of repeated ATTN201 stimulation, assessed by the incidence, severity, and relatedness of AEs and SAEs.
Incidence of New Clinically Significant Findings on Post-Treatment Safety MRI
Time frame: From baseline through the post-treatment (~Week 5)
Post-treatment brain MRI compared with the baseline MRI and reviewed for new clinically significant findings.
Study completion rate and adherence to scheduled study procedures
Time frame: From baseline through the post-treatment (~Week 5)
Proportion of randomized participants who complete all scheduled study procedures with acceptable adherence.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Early-onset Alzheimer's disease, as defined by a diagnosis occurring prior to age 65.
- 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 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.
- Is on medication which, in the opinion of the investigator, will confound 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 any contraindications for completing a brain MRI scan. a. The subject's head must fit within the head coil.
- Has an uncontrolled medical condition which may impact study results.
- Is or has an immediate family member of staff directly involved with this trial.
Where
- San Francisco, California
Collaborators
Attune Neurosciences Inc, Gates Ventures
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 14, 2026 · Source of record for eligibility and locations