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NCT04510168 · ClinicalTrials.gov registry record
Accelerated Non-Atherosclerotic Brain Arterial Aging Relationship to Alzheimer's Disease
A clinical trial of Alzheimer Disease and Dementia, sponsored by Jose Gutierrez, MD, MPH.
- Completed
- Registry status
- 238
- Enrollment target
- 1
- Study location
NCT04510168: Completed study of Alzheimer Disease and Dementia, sponsored by Jose Gutierrez, MD, MPH.
NCT04510168 is a study of Alzheimer Disease and Dementia that has completed, run by Jose Gutierrez, MD, MPH. The registered enrollment target is 238 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04510168, a study of Alzheimer Disease and Dementia, has completed, sponsored by Jose Gutierrez, MD, MPH.
- COMPLETED
- Registry status
- 238 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
Concentration of radioactivity of Florbetaben (to mark amyloid deposition) in each target region of interest (prefrontal cortex, superior temporal gyrus, combined middle/inferior temporal gyri, medial temporal cortex, superior parietal lobule, inferior parietal lobule, posterior cingulate cortex, and occipital cortex) will be divided by that in cerebellar gray matter to calculate standardized uptake values (SUVRs).
Conditions Studied
Interventions
- DRUG 11C-ER176
- OTHER Magnetic Resonance Imaging
- DRUG Florbetaben
- DRUG [F-18]MK-6240
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2020-09-18 |
| Est. Completion | 2024-04-17 |
What the finished NCT04510168 record still lists
NCT04510168 is an observational study that tracks outcomes without assigning an intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 4 interventions - of which 11C-ER176 is the first listed.
NCT04510168 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04510168 about?
NCT04510168 is a clinical study titled "Accelerated Non-Atherosclerotic Brain Arterial Aging Relationship to Alzheimer's Disease". 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...
What is the current status of trial NCT04510168?
This trial is currently completed. The enrollment target is 238 participants. The study started on 2020-09-18. Estimated completion is 2024-04-17.
What conditions does trial NCT04510168 study?
This clinical trial studies the following conditions: Alzheimer Disease, Dementia.
What interventions are being tested in trial NCT04510168?
The interventions under investigation include: 11C-ER176 (DRUG), Magnetic Resonance Imaging (OTHER), Florbetaben (DRUG), [F-18]MK-6240 (DRUG).
Who is sponsoring clinical trial NCT04510168?
This trial is sponsored by Jose Gutierrez, MD, MPH, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04510168 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04510168's enrollment target sits among peer trials
238 99th of 306 higher than 208 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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