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Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03389698
Enrollment
27
Registered
2018-01-03
Start date
2018-12-18
Completion date
2023-07-11
Last updated
2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief 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.

Interventions

DEVICEGRASP 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.

DEVICE3T Brain Scan

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

DRUGGadolinium-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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Permeability Surface Area (PS) as Measured by GRASP DCE-MRI SequenceUp to 21 MinutesPS 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.
Blood-Brain Barrier (BBB) Permeability as Measured by GRASP DCE-MRI SequenceUp to 21 MinutesGolden-angle Radial Sparse Parallel (GRASP) dynamic contrast-enhanced (DCE) MRI sequence will be collected for the quantification of subtle BBB leakage throughout the brain.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026