RecruitingNot applicable

Ultrasonic Debris Clearance to Promote Brain Resilience

Safety and Feasibility Trial of Ultrasonic Debris Clearance to Promote Brain Resilience

Who can join

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

Age
18 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

  • Procedures mentioned: Ultrasound

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
  • "This pilot study will evaluate the safety, tolerability, and feasibility of Ultrasonic Debris Clearance (UDC), a noninvasive low-intensity focused ultrasound intervention, in amyloid-positive adults who are asymptomatic but at risk for Alzheimer's disease, or who have mild cognitive impairment or mild dementia."
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 small study tests whether repeated Ultrasonic Debris Clearance (UDC) treatments are safe, well tolerated, and practical to give. UDC uses low-power sound waves aimed at the brain without surgery. It is for adults with positive tests for proteins linked to Alzheimer's disease who have no symptoms but are at risk, mild memory or thinking problems, or mild dementia.

This pilot study will evaluate the safety, tolerability, and feasibility of Ultrasonic Debris Clearance (UDC), a noninvasive low-intensity focused ultrasound intervention, in amyloid-positive adults who are asymptomatic but at risk for Alzheimer's disease, or who have mild cognitive impairment or mild dementia. The study is designed to test whether repeated UDC sessions can be delivered safely and feasibly in this population, while also exploring efficacy via biomarkers and clinical measures.

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 18 or older.
  • Have a doctor-reported positive test for proteins linked to Alzheimer's disease, from a PET brain scan, a past spinal fluid test, or a pTau-217 blood test.
  • Have no dementia or only very mild or mild dementia, with a Clinical Dementia Rating (CDR) score of 1 or less.
  • Be able and willing to attend six treatments, sitting for up to one hour with an ultrasound device on your scalp.
  • Be able and willing to have MRI scans, blood tests, and memory and thinking tests.
  • Be able to understand the study and sign a consent form.
  • Women under 60 must complete a pregnancy check, including a urine pregnancy test if they have not gone through menopause.

Who can't join

  • Moderate or severe dementia; brain tumors; brain bleeding beyond tiny spots; or other current or past conditions affecting the brain or spinal cord.
  • Metal, air, large calcium deposits, or hair or head coverings that cannot be adjusted and would block the sound waves or prevent good contact with the scalp.
  • Cannot safely have an MRI, fear of enclosed spaces, or metal in the head that prevents clear MRI pictures; allergy or intolerance to ultrasound gel or silicone.
  • Treatment with anti-amyloid antibody medicines within six months before screening.
  • Moderate or worse depression, or serious thoughts of suicide or suicidal behavior.
  • Blood test results showing low levels of red blood cells, certain infection-fighting white blood cells, or platelets, which help blood clot.
  • Significant liver, kidney, lung, heart, or metabolic disease; heart rate below 50 or above 100 beats per minute; poorly controlled blood pressure; or diabetes with an HbA1c above 7.5.
  • An active serious infection, another body-wide illness affecting the brain or spinal cord, or another health condition that would make study results hard to understand.

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

Official eligibility criteria

Inclusion Criteria: 1.1. Physician-reported amyloid positivity diagnosed by amyloid positron emission tomography (PET) OR historic CSF positivity of Abeta42, total tau, or phosphorylated tau OR positivity of plasma pTau-217. 1.2. Age ≥ 18 years. No gender/sex, racial, or ethnic preference. Subjects greater than 60 years of age will be assumed to be non-pregnant based on age and expected post-menopausal status. Female subjects under the age of 60 will complete a two-step assessment of pregnancy status (a self-reported assessment of menopause that proceeds to a urine human chorionic gonadotropin (hCG) test to confirm non-pregnancy, if the participant is not post-menopausal). 1.3. CDR Scale score less than or equal to 1.0, consistent with mild, very mild, or no dementia. 1.4. Ability and willingness to comply with the study procedures (six sessions sitting in a procedure chair for up to one hour for the procedure, with an ultrasound device placed on their scalp; additional time for the MRI assessment, blood draws, and cognitive assessments). 1.5. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 2.1. Dementia of moderate or higher severity (CDR \> 1.0) 2.2. Intracranial tumors, acute or chronic hemorrhage (beyond petechiae/microhemmorhage), or other current or historic central nervous system specific pathology. Baseline MRI studies will be screened by the protocol director to ensure no exclusionary intracranial pathology is present. 2.3. Any other comorbidity that would prevent adequate interpretation of the study results per the treatment team (e.g. congenital brain malformations without clinical importance) 2.4. Ultrasound attenuators along the ultrasound beam path (metal, air, or bulky calcification) including thick hair or related adornments that cannot be undone for the study (e.g. turbans, dreadlocks, hairweaves/wigs) that would prevent adequate ultrasound gel coupling of the device to the scalp or could trap air in the ultrasound beam path. 2.5. Contraindications to MRI (unknown device, claustrophobia) or metallic hardware in the head that prevent adequate MRI visualization of the brain 2.6. Allergy or similar intolerance to the materials used for ultrasound device coupling (ultrasound gel, silicone) 2.7. Receipt of anti-amyloid monoclonal antibody therapy within 6 months prior to screening 2.8. Moderate or greater depressive symptoms at screening, defined as a Patient Health Questionnaire-9 (PHQ-9) total score \>= 10. 2.9. Clinically significant suicidal ideation or behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) 2.10. Clinically significant hematologic abnormalities, defined as hematocrit \< 35% for male or \< 32% for female, absolute neutrophil cell count \< 1500/uL, absolute lymphocyte count \< 900/uL, or platelet count \< 120,000/uL 2.11. Clinically significant hepatic, renal, respiratory, cardiovascular, or metabolic disease that increases risk or interferes with interpretation, defined as ALT/AST/ALP \> 1.5 ULN, or eGFR \< 50 mL/min/1.73m2, or recent MI/unstable angina/HF/cardiomyopathy within 6 months, 2.12. Significant bradycardia(\<50/min) or tachycardia (\>100/min) 2.13. Poorly controlled BP 2.14. Uncontrolled diabetes, defined as HbA1c \> 7.5 2.15. Active clinically significant infection or other systemic illness affecting the CNS

Study sites (1)

CA