NCT04510168Completed
Accelerated Non-Atherosclerotic Brain Arterial Aging Relationship to Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 16 Jul 2024
Brief summary (registry, in English)
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 with Alzheimer disease have frequently evidence of vascular disease in the brain, and vascular disease can increase the risk of Alzheimer disease. Based on this finding, the investigators plan to expand the understanding of how vascular disease contributes to Alzheimer disease, hoping to identify novel target to modify the natural progression of the disease. The investigators will accomplish this goal by inviting 300 participants (with and without dementia) of the Northern Manhattan Study (NOMAS) to undergo a brain magnetic resonance imaging (MRI) and donate blood. Of the 300 participants enrolled, 60 participants will be randomly selected to undergo Aβ and tau positron emission tomography (PET) imaging. From the brain MRI, the investigators will obtain measurements of cerebrovascular disease and relate the to the risk of Alzheimer disease. With the blood, the investigators hope to identify measures of aging and inflammation that may predict changes noted in brain scan and identify people at a higher risk of dementia. The investigators will examine PET markers of inflammation and aging in the brain and how the markers relate to dementia.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 238 (actual)
- First submitted
- 10 Aug 2020
- Start date
- 18 Sept 2020
- Primary completion date
- 16 Apr 2024
- Lead sponsor
- Jose Gutierrez, MD, MPH
- Diseases
- Alzheimer disease
- NCT number
- NCT04510168
What you commit to
- Study type: Observational
- Participants enrolled: 238
- From 18 Sept 2020 to the primary completion date, 16 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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)).
- Conditions precluding entry into the scanners (e.g., morbid obesity, claustrophobia, etc.).
- 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.
Other
- Contraindication to MRI scanning
- Inability to have a catheter in subject's vein for the injection of radioligand.
- Inability to have blood drawn from subject's veins.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.