Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD

NCT ID: NCT03389698

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-18

Study Completion Date

2023-07-11

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cohort A

Cognitively normal control participants aged 20 - 40 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time.

GRASP Dynamic Contrast-Enhanced (DCE) MRI

Intervention Type 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

Intervention Type DEVICE

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

Gadolinium-based Contrast Agent (GBCA) for MRI

Intervention Type 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.

Cohort B

Cognitively normal control participants aged 65 - 85 years. Participants will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 21 minutes of scan time.

GRASP Dynamic Contrast-Enhanced (DCE) MRI

Intervention Type 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

Intervention Type DEVICE

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

Gadolinium-based Contrast Agent (GBCA) for MRI

Intervention Type 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.

Cohort C

Amnestic mild cognitive impairment (aMCI) patients aged 65 and older. Participants in Cohort C will be matched by age and gender to participants in Cohort B. Participants in Cohort C will undergo a 3T brain scan that will last up to 60 minutes using the GRASP DCE-MRI sequence performed during the first 9 minutes of scan time.

GRASP Dynamic Contrast-Enhanced (DCE) MRI

Intervention Type 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

Intervention Type DEVICE

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

Gadolinium-based Contrast Agent (GBCA) for MRI

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

3T Brain Scan

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

Intervention Type DEVICE

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.

Intervention Type DRUG

Other Intervention Names

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Gadavist/Gadobutrol

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yulin Ge, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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17-01336

Identifier Type: -

Identifier Source: org_study_id

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