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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):

December 26, 2017
January 3, 2018
January 3, 2018
February 2018
February 2019   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD
Developing Advanced Blood-Brain Barrier Permeability Imaging for Early Alzheimer's Disease
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.
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Interventional
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Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Alzheimer Disease
  • 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: Heatlthy Control Group
    cognitively normal (CN) subjects in two age groups: young(20-40) and old (65-85)
    Interventions:
    • Device: GRASP DCE-MRI
    • Device: 3T Brain Scan
  • Active Comparator: Amnestic mild cognitive impairment (aMCI)
    32 participants who have aMCI.
    Interventions:
    • Device: GRASP DCE-MRI
    • Device: 3T Brain Scan
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
February 2021
February 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 85 Years   (Adult, Senior)
Yes
Contact: Fatemeh Adlparvar 212 263 0380 Fatemeh.Adlparvar@nyumc.org
United States
 
 
NCT03389698
17-01336
No
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
Not Provided
New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Yulin Ge, MD New York University School of Medicine
New York University School of Medicine
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP