Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD

Alzheimer Disease Clinical Trial

Official title:

Developing Advanced Blood-Brain Barrier Permeability Imaging for Early Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389698
• Other study ID #: 17-01336
• Status: Completed
• Start date: December 18, 2018
• Est. completion date: July 11, 2023

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aging is the primary risk factor in aging-related dementia. An important initiating factor for the development and progression of cognitive impairment is disruption of the blood-brain barrier (BBB). BBB plays an important role in maintaining normal brain homeostasis and protecting neural tissues from toxins. It is hypothesized that such changes known to be common in aging and can be an early process that precedes Alzheimer's Disease (AD). The microvascular changes related to subtle BBB disruption can be measured with permeability-surface area (PS) derived from GRASP DCE-MRI acquired less than 10 minutes, and the patterns of increased PS in normal and abnormal aging are different.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 11, 2023
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subjects that have been diagnosed with aMCI ages 65-85

Exclusion Criteria:

• Pregnant, planning to get pregnant, or nursing.

• Claustrophobia

• Cardiac pacemaker

• Intracranial clips, metal implants, unremovable jewelries, metal in eyes.

• History or presence of any other major medical, neurologic or psychiatric conditions, such as Alzheimer's diseases, Parkinson's diseases, and stroke.

• Renal or liver disease as this may cause concerns related to Gad-based contrast agent

• Allergy to the contrast agent Gadolinium

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• GRASP Dynamic Contrast-Enhanced (DCE) MRI
Golden-angle Radial Sparse Parallel (GRASP) DCE MRI is an MRI sequence designed to improve spatial and temporal resolution while enabling retrospective reconstruction with flexible temporal resolution.
• 3T Brain Scan
Up to 60 minutes, a portion of which uses the GRASP DCE-MRI sequence.

Drug:
• Gadolinium-based Contrast Agent (GBCA) for MRI
Gadavist/Gadobutrol is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Permeability Surface Area (PS) as Measured by GRASP DCE-MRI Sequence	PS is measured by quantifying the contrast agent flow through blood vessel walls per unit volume of brain while accounting for the blood flow rate in the vessel.	Up to 21 Minutes
Primary	Blood-Brain Barrier (BBB) Permeability as Measured by GRASP DCE-MRI Sequence	Golden-angle Radial Sparse Parallel (GRASP) dynamic contrast-enhanced (DCE) MRI sequence will be collected for the quantification of subtle BBB leakage throughout the brain.	Up to 21 Minutes