Status:
COMPLETED
Accelerated Non-Atherosclerotic Brain Arterial Aging Relationship to Alzheimer's Disease
Lead Sponsor:
Jose Gutierrez, MD, MPH
Conditions:
Alzheimer Disease
Dementia
Eligibility:
All Genders
50+ years
Brief Summary
The aging of the United States (US) population will lead to a steep rise in Alzheimer disease (AD). There is an urgent need for novel therapies that may tackle this looming societal problem. People wi...
Detailed Description
Research about non-atherosclerotic BAA and its effects on cognition has been hampered by the lack of high-resolution arterial wall imaging, the preponderance of research focused on intracranial large ...
Eligibility Criteria
Inclusion
- Age 50 and older
- Being part of the NOMAS MRI substudy
- Subjects unable to provide informed consent must have a surrogate decision maker
- Written and oral fluency in English or Spanish
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
- In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.
Exclusion
- Past or present history of certain brain disorders other than Mild Cognitive Impairment (MCI) or Alzheimer's disease (AD) (self-reported brain tumor, dementia of Lewy body, frontotemporal dementia).
- Certain significant medical conditions, which make study procedures of the current study unsafe (liver cirrhosis, end-stage renal disease on dialysis, terminal cancer (death expected within 6 months)).
- Contraindication to MRI scanning
- Conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.).
- Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.
- Participation in a clinical trial for a disease-modifying drug for AD the year prior to the date of the first PET scan.
- Inability to have a catheter in subject's vein for the injection of radioligand.
- Inability to have blood drawn from subject's veins.
- Subjects will not be included in the study if they have participated in the last year in a clinical trial for a disease-modifying drug for AD.
Key Trial Info
Start Date :
September 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 17 2024
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04510168
Start Date
September 18 2020
End Date
April 17 2024
Last Update
July 16 2024
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032