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

NCT04118764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-08-26

Study results available
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Summary

The purpose of this study is to test a new technique that may, in the future, help deliver medications to the brain of people with Alzheimer's disease. Participants in this study will undergo a focused ultrasound treatment to the brain, along with Magnetic Resonance Imagine (MRI) and Positron Emission Tomography (PET) scans.

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.

Sponsors & Collaborators

Principal Investigators

  • Elisa Konofagou, PhD · Columbia University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-06
Primary Completion
2022-07-11
Completion
2022-09-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04118764 on ClinicalTrials.gov