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Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD

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ClinicalTrials.gov Identifier: NCT03389698
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : August 15, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE December 26, 2017
First Posted Date  ICMJE January 3, 2018
Last Update Posted Date August 15, 2022
Actual Study Start Date  ICMJE December 18, 2018
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2017)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD
Official Title  ICMJE Developing Advanced Blood-Brain Barrier Permeability Imaging for Early Alzheimer's Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 26, 2017)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Charles Morton 212-263-7541 Charles.Morton@nyulangone.org
Contact: Danielle Costanzo 212 263 0380 Danielle.Costanzo@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03389698
Other Study ID Numbers  ICMJE 17-01336
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party NYU Langone Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE NYU Langone Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yulin Ge, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date February 2022

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