Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD
NCT ID: NCT03389698
Last Updated: 2024-01-30
Study Results
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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COMPLETED
27 participants
OBSERVATIONAL
2018-12-18
2023-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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.
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.
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
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.
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.
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
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.
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.
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.
3T Brain Scan
Up to 60 minutes, a portion of which uses the GRASP DCE-MRI sequence.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
20 Years
85 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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17-01336
Identifier Type: -
Identifier Source: org_study_id
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