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Focused Ultrasound for Alzheimer's Disease

This study is testing a new way to temporarily open the blood-brain barrier (BBB) in people with Alzheimer's disease using a device called a neuronavigation-guided single-element focused ultrasound transducer. This device works with Lumason microbubbles to allow the ultrasound to have its effect. The main goal is to see if this method is safe and if the BBB opening is reversible. Researchers will also use MRI scans and PET scans with Amyvid and MK-6240 to measure amyloid and tau protein levels in the brain before and after treatment. This study is for people over 50 with Alzheimer's disease or mild cognitive impairment (MCI) who can give consent. The study aims to enroll 6 participants. The current status of the study is unclear.

Study design
This is a Phase 1b interventional study with a planned enrollment of 6 participants. It is designed to assess the safety and reversibility of focused ultrasound-induced BBB opening.
What's involved
You would undergo focused ultrasound treatment, receive Lumason microbubbles, and have MRI and PET scans (with Amyvid and MK-6240 tracers) before and after treatment.
Compensation
Not stated in the trial record.
Follow-up
Amyloid and tau protein levels will be assessed at 3 weeks and 3 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06600880

Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau

Not Yet Recruiting
PHASE1Ages 50+InterventionalDevice feasibility
Columbia University
~6 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Neuronavigation-guided single-element focused ultrasound transducerLumasonMagnetic Resonance Imaging (MRI) with or without gadolinium contrast agentsPositron Emission Tomography (PET)AmyvidMK-6240

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total Number of Individuals With Successful Opening of the BBB
Measured over 4 days, including the day of treatment

Conditions

Alzheimer Disease, Early Onset

Explore related trials

Alzheimer's DiseaseMild cognitive disorderMicrotubule-Associated Protein Tau

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Grace McIlvain, PhD · PRINCIPAL_INVESTIGATOR · Columbia University

Who to contact

Sergio Jimenez Gambin, PhD
[email protected]
9295455655 · ext. 1
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Total Number of Individuals With Successful Opening of the BBB4 days, including the day of treatment

    Opening the BBB successfully in all the patients, while obtaining a volume of BBB opened being similar and consistent for all patients