RightFit
RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks
  • Procedures mentioned: Ultrasound, Wearing a device, MRI scans, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The goal of this clinical trial is to learn if a wearable ultrasound device, called ATTN201, is safe and easy to use."
  • "Researchers will compare focused ultrasound to unfocused ultrasound."
  • "Unfocused ultrasound is a look-alike treatment."
  • "This pilot study is a randomized, double-blind, parallel-group trial of repeated low-intensity focused ultrasound (LIFU) stimulation of the centromedian nucleus of the thalamus (CMN) in amyloid-positive older adults with mild cognitive impairment (MCI)."
  • "Low-Intensity focused ultrasound can both elicit neural activity in the CMN and directly produce fluid flow, non-invasively and with lightweight hardware."
  • "Bilateral 64-element sparse ultrasound arrays operating at 500 kHz are positioned over the temporal windows and deliver cross-beam focused stimulation to deep brain targets."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ATTN201, a wearable ultrasound device, is safe and easy to use. It is for adults age 65 and older with mild cognitive impairment (mild memory or thinking problems) and amyloid protein buildup in the brain. Researchers will compare focused and unfocused sound waves to see whether treatment changes sleep brain waves, blood signs of Alzheimer's disease, or memory and thinking.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 65 or older and qualify for a diagnosis of mild cognitive impairment.
  • Have amyloid buildup shown by a PET scan, spinal fluid test, or blood test.
  • Have a study partner who can answer questions about you.
  • Be willing and able to have a brain MRI scan and wear the study device during treatments.
  • If taking Alzheimer's or sleep medicines, keep the same doses for at least 3 weeks before screening and during the study. Stay under your treating neurologist's care during the study.
  • Be able to sign a form agreeing to join and speak, read, and understand the language used by study staff and the form.
  • Be able to answer questions aloud, follow instructions, complete tests, and follow the treatment and visit schedule.
  • Have stable health, based on your health history, safety lab tests, and vital signs.

Who can't join

  • Alzheimer's disease diagnosed before age 65, or significant depression with a score above 10 on the study's depression scale.
  • Untreated moderate to severe obstructive sleep apnea, which causes breathing to stop and start during sleep.
  • Medical or mental health problems that could affect study activities or results, including an uncontrolled medical condition.
  • Taking medicines that the study doctor thinks could affect the results.
  • Past deep brain stimulation or ablative surgery, which destroys tissue, or a past brain injury caused by trauma.
  • Substance abuse, including alcohol use disorder, within the past 6 months.
  • Any reason you cannot have a brain MRI, including your head not fitting in the scanner's head coil.
  • Being a staff member directly involved in this trial or an immediate family member of one.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CA