Alzheimer s DiseaseNCT07573982
Ultrasonic Debris Clearance to Promote Brain Resilience
A study testing Ultrasonic Debris Clearance in people with Alzheimer s Disease and MCI With Increased Risk for Alzheimer Disease, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer s Disease, MCI With Increased Risk for Alzheimer Disease
- What is being tested?
- Ultrasonic Debris Clearance
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Masataka Wada, MD PhD, 650-724-1190, mwada@stanford.edu
About this study
Official title: Safety and Feasibility Trial of Ultrasonic Debris Clearance to Promote Brain Resilience
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.
- Being tested
- Ultrasonic Debris Clearance, sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Debris ClearanceDevice
Ultrasonic debris clearance (UDC) delivered with a 250-kHz low-intensity transcranial ultrasound device for approximately 30 minutes per session across 8 sessions over 4 weeks. The intervention is designed to provide broad transcranial ultrasound exposure to promote glymphatic clearance, with real-time monitoring of transmitted power and matched study procedures including EEG, MRI, blood, and clinical assessments.
shamDevice
Sham procedure matched to the active UDC intervention in schedule, session duration, device setup, and study procedures, but without transcranial ultrasound energy delivery while maintaining participant blinding.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Participants will receive the UDC ultrasound protocol applied to their head for multiple sessions across one month. Receives: Device: Ultrasonic Debris Clearance |
| Sham | Sham comparator | Participants will receive a sham version of the UDC ultrasound protocol applied to their head for multiple sessions across one month. Receives: Device: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events
All reported adverse events including clinically meaningful vital sign changes, laboratory test abnormalities, physical and cognitive symptoms, and new imaging abnormalities not present at baseline.
Measured: baseline through 2 months post-treatment initiation (up to 3 months)
Secondary outcomes (5)
Changes from baseline in a tablet-based cognitive assessment
Changes from baseline in tablet-based cognitive task performance (tabCAT) in the treatment condition compared to the sham
Measured: baseline through 1 month post-treatment initiation (up to 3 months)
Change From Baseline in Clinical Dementia Rating - Sum of Boxes Score
The Clinical Dementia Rating - Sum of Boxes assesses cognitive and functional impairment associated with dementia. Total scores range from 0 to 18, with higher scores indicating greater impairment and a worse outcome.
Measured: baseline, 1 month post-treatment initiation (up to 3 months)
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 Score
The Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 assesses cognitive impairment associated with Alzheimer's disease. Total scores range from 0 to 85, with higher scores indicating greater cognitive impairment and a worse outcome.
Measured: baseline, 1 month post-treatment initiation (up to 3 months)
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living for Mild Cognitive Impairment Score
The Alzheimer's Disease Cooperative Study - Activities of Daily Living for Mild Cognitive Impairment assesses functional ability in activities of daily living in individuals with mild cognitive impairment. Total scores range from 0 to 53, with higher scores indicating better functional ability and a better outcome.
Measured: baseline, 1 month post-treatment initiation (up to 3 months)
Change From Baseline in Mini-Mental State Examination Score
The Mini-Mental State Examination assesses global cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function and a better outcome.
Measured: baseline, 1 month post-treatment initiation (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raag Airan, Stanford University
- Investigators
- Raag Airan, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573982
- Sponsor's protocol ID
- 85009
- Status last verified
- Oct 2026
- First submitted
- 1 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Trial of Ultrasonic Debris Clearance to Promote Brain Resilience
- ClinicalTrials.gov ID
- NCT07573982
- Acronym / sponsor ID
- 85009
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Ultrasonic Debris ClearanceParticipants will receive the UDC ultrasound protocol applied to their head for multiple sessions across one month. |
| Sham | Sham comparator | Device: shamParticipants will receive a sham version of the UDC ultrasound protocol applied to their head for multiple sessions across one month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic Debris ClearanceUltrasonic debris clearance (UDC) delivered with a 250-kHz low-intensity transcranial ultrasound device for approximately 30 minutes per session across 8 sessions over 4 weeks. The intervention is designed to provide broad transcranial ultrasound exposure to promote glymphatic clearance, with real-time monitoring of transmitted power and matched study procedures including EEG, MRI, blood, and clinical assessments. | Device | Active |
| shamSham procedure matched to the active UDC intervention in schedule, session duration, device setup, and study procedures, but without transcranial ultrasound energy delivery while maintaining participant blinding. | Device | Sham |
Primary outcome
Number of Participants with Treatment-Related Adverse Events
Time frame: baseline through 2 months post-treatment initiation (up to 3 months)
All reported adverse events including clinically meaningful vital sign changes, laboratory test abnormalities, physical and cognitive symptoms, and new imaging abnormalities not present at baseline.
5 secondary outcomes
Changes from baseline in a tablet-based cognitive assessment
Time frame: baseline through 1 month post-treatment initiation (up to 3 months)
Change From Baseline in Clinical Dementia Rating - Sum of Boxes Score
Time frame: baseline, 1 month post-treatment initiation (up to 3 months)
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 Score
Time frame: baseline, 1 month post-treatment initiation (up to 3 months)
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living for Mild Cognitive Impairment Score
Time frame: baseline, 1 month post-treatment initiation (up to 3 months)
Change From Baseline in Mini-Mental State Examination Score
Time frame: baseline, 1 month post-treatment initiation (up to 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raag Airan, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Debris Clearance in people with Alzheimer s Disease and MCI With Increased Risk for Alzheimer Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Masataka Wada, MD, PhD (650-724-1190, mwada@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events (time frame: baseline through 2 months post-treatment initiation (up to 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.