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OpenTrials
Completed

NCT Number: NCT03389698

Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GRASP Dynamic Contrast-Enhanced (DCE) MRI

Device

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

Device

Up to 60 minutes, a portion of which uses the GRASP DCE-MRI sequence.

Gadolinium-based Contrast Agent (GBCA) for MRI

Drug

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.

Other names: Gadavist/Gadobutrol

Primary outcomes

  1. Permeability Surface Area (PS) as Measured by GRASP DCE-MRI Sequence

    Time frame: Up to 21 Minutes

    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.

  2. Blood-Brain Barrier (BBB) Permeability as Measured by GRASP DCE-MRI Sequence

    Time frame: Up to 21 Minutes

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jan 3, 2018
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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