Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD

Completed

• Conditions: Alzheimer Disease
• Interventions: Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI; Device: 3T Brain Scan; Drug: Gadolinium-based Contrast Agent (GBCA) for MRI

• Registration Number: NCT03389698
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-26
• Study First Submitted QC: 2017-12-26
• Study First Posted: 2018-01-03
• Study Start: 2018-12-18
• Primary Completion: 2022-01-28
• Study Completion: 2023-07-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	GRASP Dynamic Contrast-Enhanced (DCE) MRI	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.
Cohort A	3T Brain Scan	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.
Cohort A	Gadolinium-based Contrast Agent (GBCA) for MRI	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.
Cohort B	GRASP Dynamic Contrast-Enhanced (DCE) MRI	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.
Cohort B	3T Brain Scan	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.
Cohort B	Gadolinium-based Contrast Agent (GBCA) for MRI	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.
Cohort C	GRASP Dynamic Contrast-Enhanced (DCE) MRI	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.
Cohort C	3T Brain Scan	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.
Cohort C	Gadolinium-based Contrast Agent (GBCA) for MRI	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.

Primary Outcome Measures

Name	Time	Method
Blood-Brain Barrier (BBB) Permeability as Measured by GRASP DCE-MRI Sequence	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.
Permeability Surface Area (PS) as Measured by GRASP DCE-MRI Sequence	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States