LIFU to Help Sleep and Amyloid Reduction in Older Adults with Cognitive Impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study randomizes participants to focused versus unfocused low-intensity focused ultrasound (LIFU) targeting the centromedian nucleus of the thalamus to see if it can improve deep-sleep brain waves and support waste clearance in the brain. It is a randomized, double-blind, parallel-group trial designed to assess safety, usability, and adherence to a home-use device. The study uses a head-worn system that operates offline and does not require real-time imaging or clinician guidance. Primary aims include identifying device-related issues and whether participants can complete the full study schedule. The trial is conducted in older adults with amyloid positivity and mild cognitive impairment.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Andrew Krystal, MD — University of California, San Francisco
• Study coordinator: Andrew D Krystal, MD
• Email: clear@ucsf.edu
• Phone: 415-514-0446

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Longitudinal profiling of plasma-derived glial extracellular vesicles in Alzheimer's disease

  This study tests whether plasma glial extracellular vesicles and neuroinflammation biomarkers change over time across the Alzheimer’s disease spectrum and whether these signals relate to amyloid, tau, and neurodegeneration, with an additional step of exposing healthy iPSC-derived neurons to vesicles to see potential ne

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Rome · NCT07803055

• Gut methane and Parkinson's: measuring if a probiotic helps people with Parkinson's, REM sleep behavior disorder, or cognitive concerns

  This study tests whether a probiotic containing Limosilactobacillus reuteri can help people with Parkinson's disease, those at high risk for PD, and related cognitive issues by potentially improving gut methane levels and overall symptoms.

  Recruiting University of Cambridge · Cambridge, CB2 · NCT07786116

• Mindfulness meditation for improving cognition in older adults

  This study is testing whether mindfulness meditation can help older adults, including those with mild cognitive impairment, improve their thinking, memory, and overall quality of life.

  Recruiting VA Boston Healthcare System · Boston, Massachusetts · NCT06792877

• Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease in Real World Practice

  This study will look at real-world safety and effectiveness of disease-modifying therapy (DMT) in adults with MCI or Alzheimer's dementia by comparing those who receive DMT in routine care to those who do not.

  Recruiting Fudan University · Shanghai, Jingan · NCT07923812

• Rural Veterans and Care Partners Walking Program

  A virtual walking program is tested to see if it can help Veterans with mild cognitive impairment and their care partners in rural areas walk more each day.

  Recruiting Creighton University · Omaha, Nebraska · NCT07914218

• China HEAD: a large community study on healthy aging and dementia

  This study tests whether collecting health, imaging, and biospecimen data from adults in China can help predict who will develop Alzheimer’s disease and related dementias.

  Recruiting at 30 sites Fudan University · Beijing and 29 other locations · NCT07912710

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.