CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
Definity +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04118764
NCT04118764N/ACompleted
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Neuronavigation-guided Focused Ultrasound-induced Blood-brain Barrier Opening in Alzheimer's Disease Patients

Columbia University·interventional·Posted Oct 8, 2019·Updated Aug 26, 2024

In Brief

A clinical study evaluating Neuronavigation-guided single-element focused ultrasound transducer, Definity, and 3 other interventions for Alzheimer Disease. Completed, enrolled 6 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA)

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 8, 2019
Enrollment StartAug 6, 2020
Primary CompletionJul 11, 2022
Study CompletionSep 28, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.7 years ago

Interventions

Neuronavigation-guided single-element focused ultrasound transducerdevice

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

Definitydrug

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

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

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.

Positron Emission Tomography (PET)other

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

Amyvidother

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