NCT06600880Not yet recruitingPhase 1
Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau
Neuronavigation-guided Focused Ultrasound-induced Blood-brain Barrier Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
The primary purpose of this phase 1b study is to further assess the safety and reversibility of focused ultrasound induced blood-brain barrier opening (FUS-BBBO) in participants with Alzheimer´s Disease (AD) using a single-element transducer with neuronavigation guidance. Preliminary results from our phase 1a study demonstrate that our neuronavigation-guided FUS system was capable of safely and transiently open the BBB in participants with AD. The information collected in this new study may be used to design future clinical trials to ultimately provide a viable alternative for treatment of AD in a safe and noninvasive manner. Our secondary objective includes the assessment of the therapeutic efficacy of FUS-BBBO in reducing amyloid beta and neurofibrillary tangles, the main hallmark pathologies of AD, using PET tracers. Based on our preclinical studies in AD transgenic mouse models, FUS-BBBO alone was able to reduce both the amyloid beta and tau protein load, resulting in improvements in behavioral tasks assessing memory. Therefore, in this new study, the effect of FUS-BBBO on the amyloid beta and tau protein load in patients with AD will be assessed through the use of PET tracers.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 11 Sept 2024
- Start date
- Aug 2027
- Primary completion date
- Jul 2028
- Lead sponsor
- Columbia University
- Diseases
- Alzheimer disease
- NCT number
- NCT06600880
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 6
- From Aug 2027 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior administration of any amyloid-reducing agent such as aducanumab or lecanemab.
- Prior brain surgery, including deep brain stimulation.
- Metallic implants.
- Anticoagulant therapy.
Other illness
- Contra-indication history or hypersensitivity to MRI contrast agents (e.g., Dotarem) or microbubbles (e.g., Definity, Lumason), including polyethylene glycol (PEG) allergy.
- History of seizure disorder.
- Active infection/inflammation.
- Any uncontrolled medical disorder that might interfere with the ability to safely perform the study.
Lab values
- Abnormal coagulation profile (significant abnormality in PT, PTT, or platelets).
- 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.
Other
- Contraindication for MRI.
- 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.
- Acute or chronic hemorrhages, i.e. \> 4 lobar microbleeds, or an area of siderosis or macrohemorrhages.
- Tumors or space-occupying lesions of significance.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.