Status:
NOT_YET_RECRUITING
Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau
Lead Sponsor:
Columbia University
Conditions:
Alzheimer Disease, Early Onset
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief 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 Disea...
Detailed Description
Regarding the primary purpose of this study, the human module for the neuronavigator was implemented in our phase 1a trial, and initial feasibility and safety in a small cohort of AD patients had been...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06600880
Start Date
August 1 2026
End Date
December 1 2027
Last Update
May 11 2025
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032