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Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD

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ClinicalTrials.gov Identifier: NCT03389698
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Alzheimer Disease Device: GRASP DCE-MRI Device: 3T Brain Scan

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Developing Advanced Blood-Brain Barrier Permeability Imaging for Early Alzheimer's Disease
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Heatlthy Control Group
cognitively normal (CN) subjects in two age groups: young(20-40) and old (65-85)
Device: GRASP DCE-MRI
DCE-MRI termed Golden-angle Radial Sparse Parallel (GRASP) significantly improves both spatial and temporal resolution while enabling retrospective reconstruction with flexible temporal resolution.
Device: 3T Brain Scan
up to 60 minutes: 3T brain scan, a portion of which uses the GRASP DCE-MRI sequence (the first 21 minutes of the scan for CN cohorts and the first 9 minutes of the scan for the Amnestic Mild Cognitive Impairment cohort)
Active Comparator: Amnestic mild cognitive impairment (aMCI)
32 participants who have aMCI.
Device: GRASP DCE-MRI
DCE-MRI termed Golden-angle Radial Sparse Parallel (GRASP) significantly improves both spatial and temporal resolution while enabling retrospective reconstruction with flexible temporal resolution.
Device: 3T Brain Scan
up to 60 minutes: 3T brain scan, a portion of which uses the GRASP DCE-MRI sequence (the first 21 minutes of the scan for CN cohorts and the first 9 minutes of the scan for the Amnestic Mild Cognitive Impairment cohort)


Outcome Measures

Primary Outcome Measures :
  1. Permeability Surface Area (PS) estimates derived from 9 min GRASP DCE reconstruction [ Time Frame: 9 Minutes ]
    to determine if are in permability surface area for GRADP measure is consistent with the estimates from the full 21 min data set


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389698


Contacts
Contact: Fatemeh Adlparvar 212 263 0380 Fatemeh.Adlparvar@nyumc.org

Locations
United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Fatemeh Adlparvar    212-263-7744    Fatemeh.Adlparvar@nyumc.org   
Principal Investigator: Yulin Ge, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Yulin Ge, MD New York University School of Medicine
More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03389698     History of Changes
Other Study ID Numbers: 17-01336
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders