Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD

NYU Langone Health

Status: Completed

Conditions: Alzheimer Disease

Treatments: Drug: Gadolinium-based Contrast Agent (GBCA) for MRI; Device: 3T Brain Scan; Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI

Study type: Observational

Funder types: Other

Identifiers

NCT03389698

17-01336

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

27 participants in 3 patient groups

Cohort A

Description:

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.

Treatment:

Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI

Device: 3T Brain Scan

Drug: Gadolinium-based Contrast Agent (GBCA) for MRI

Cohort B

Description:

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.

Treatment:

Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI

Device: 3T Brain Scan

Drug: Gadolinium-based Contrast Agent (GBCA) for MRI

Cohort C

Description:

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.

Treatment:

Device: GRASP Dynamic Contrast-Enhanced (DCE) MRI

Device: 3T Brain Scan

Drug: Gadolinium-based Contrast Agent (GBCA) for MRI