Non-invasive Blood-brain Barrier Opening in Alzheimer's Disease Patients Using Focused Ultrasound

NACompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

August 6, 2020

Primary Completion Date

July 11, 2022

Study Completion Date

September 28, 2022

Conditions
Alzheimer Disease
Interventions
DEVICE

Neuronavigation-guided single-element focused ultrasound transducer

Non-invasive focused ultrasound-induced blood-brain barrier opening will be attempted using a single-element transducer, guided with a neuronavigation system.

DRUG

Definity

Definity microbubbles (10 μl/kg) will be used in conjunction with the ultrasound transducer to temporarily open the blood brain barrier.

OTHER

Magnetic Resonance Imaging (MRI) with or without gadolinium contrast agents

MRI scans will be completed at baseline and immediately after the focused ultrasound treatment to confirm BBB opening and safety. A follow-up MRI will be performed three days after treatment to confirm BBB closure, only in the case of successful BBB opening.

OTHER

Positron Emission Tomography (PET)

A follow-up PET scan will be performed three days after treatment to determine amyloid plaque load.

OTHER

Amyvid

To be used during the PET scan to determine uptake of Amyvid within the treated area.

Trial Locations (1)

11021

Columbia University Irving Medical Center/NYPH, New York

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

Columbia University

OTHER

NCT04118764 - Non-invasive Blood-brain Barrier Opening in Alzheimer's Disease Patients Using Focused Ultrasound | Biotech Hunter | Biotech Hunter