Sound waves may help clear Alzheimer's brain clogs
NCT ID NCT06600880
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether a focused ultrasound can safely and temporarily open the brain's protective barrier in people with early Alzheimer's disease. The goal is to see if this helps clear harmful amyloid and tau proteins that build up in the brain. Six participants will receive the treatment, and researchers will monitor safety and measure protein changes using brain scans.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria. AD patients will be recruited in person and have to be over 50 years of age and able to give consent. Patients diagnosed with MCI or AD will be included in our study. Other more severe symptomatic patients will be eligible to enroll, as long as they have the ability to consent for their participation. Screening is essential and will be performed by our collaborator and neurologist of the study, Dr. Lawrence Honig, MD at the Taub Institute of Alzheimer's Disease and Aging at Columbia. After the initial screening we will acquire MRI scans as part of the study and finalize enrollment or exclusion of the patient. Inclusion criteria thus include: * Age greater than 50 years old. * Diagnosis of MCI or AD. All following criteria must be met: * MMSE score between 12 and 26. * Modified Hachinski Ischemia Scale (MHIS) score of \<= 4 * Short form Geriatric Depression Scale (GDS) score of \<= 6. * PET scan confirming amyloid plaque load using Amyvid (18F-Florbetapir). * PET scan confirming tau positivity in the frontal lobe using MK-6240 (F18-Florquinitau). * Ability to provide informed consent. Exclusion Criteria. Exclusion criteria include surgeries and other pathologies not associated with AD, as outlined in the following list: * Prior administration of any amyloid-reducing agent such as aducanumab or lecanemab. * Contraindication for MRI. * Contra-indication history or hypersensitivity to MRI contrast agents (e.g., Dotarem) or microbubbles (e.g., Definity, Lumason), including polyethylene glycol (PEG) allergy. * Prior brain surgery, including deep brain stimulation. * Metallic implants. * Abnormal coagulation profile (significant abnormality in PT, PTT, or platelets). * Anticoagulant therapy. * History of seizure disorder. * Brain atrophy to a degree that would interfere with ultrasound delivery. * Inability to comply with the procedures of the protocol, including follow-up scans. * Women with capacity to bear children or lactating. * Impaired renal function with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 provided by a standard blood test 2-4 weeks prior to the ultrasound treatment. * Active infection/inflammation. * Acute or chronic hemorrhages, i.e. \> 4 lobar microbleeds, or an area of siderosis or macrohemorrhages. * Tumors or space-occupying lesions of significance. * Any uncontrolled medical disorder that might interfere with the ability to safely perform the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University Irving Medical Center
New York, New York, 10032, United States
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Other studies related to the condition(s) this trial covers.
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