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NCT06600880 · ClinicalTrials.gov registry record · Phase 1
Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau
A Phase 1 study, sponsored by Columbia University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT06600880: Clinical Trial Phase 1 study, sponsored by Columbia University.
NCT06600880 is a Phase 1 study that has not yet begun recruiting, run by Columbia University. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06600880, a Phase 1 study, has not yet begun recruiting, sponsored by Columbia University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Opening the BBB successfully in all the patients, while obtaining a volume of BBB opened being similar and consistent for all patients
Interventions
- DRUG Lumason
- DEVICE Neuronavigation-guided single-element focused ultrasound transducer
- OTHER Magnetic Resonance Imaging (MRI) with or without gadolinium contrast agents
- RADIATION Positron Emission Tomography (PET)
- DRUG Amyvid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2027-08 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What is known before NCT06600880 opens enrollment
NCT06600880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 5 interventions - of which Lumason is the first listed.
NCT06600880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06600880 about?
NCT06600880 is a clinical study titled "Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau". 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 ou...
What is the current status of trial NCT06600880?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2027-08. Estimated completion is 2028-12.
What interventions are being tested in trial NCT06600880?
The interventions under investigation include: Lumason (DRUG), Neuronavigation-guided single-element focused ultrasound transducer (DEVICE), Magnetic Resonance Imaging (MRI) with or without gadolinium contrast agents (OTHER), Positron Emission Tomography (PET) (RADIATION), Amyvid (DRUG).
Who is sponsoring clinical trial NCT06600880?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06600880's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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