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NCT04403165 · ClinicalTrials.gov registry record · NA
Locus-coeruleus Function in Normal Elderly and AD Risk
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT04403165 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 30 participants.
The verdict
NCT04403165, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
Growing evidence suggests that Alzheimer's disease (AD) pathological changes begin decades before clinical symptoms and tau abnormalities in the locus coeruleus (LC) can be observed since midlife. We have previously demonstrated functional vulnerability of the LC to aging and stress, as well as an association between higher cerebrospinal fluid (CSF) tau and impaired sleep phenomena influenced by the LC. We now aim to test whether LC dysfunction can be measured in preclinical AD stages by LC targeted imaging, and whether it objectively affects sleep architecture and attention. We will test this hypothesis in 30 cognitively normal older adults by performing a full clinical evaluation, one night of polysomnography, a lumbar puncture to obtain cerebrospinal fluid, \[11C\]MRB PET-MR, and attention testing. This study has the potential to identify a new mechanism by which tau pathology contributes to sleep and attention dysfunction and may provide a new therapeutic target for AD prevention.
Interventions
- PROCEDURE Nocturnal polysomnography (NPSG)
- PROCEDURE Lumbar Puncture (LP)
- OTHER PET-MR measurement with a norepinephrine transporter (NET)-selective radiotracer (S,S)-[11C]Omethylreboxetine ([11C]MRB)
- BEHAVIORAL Psychomotor Vigilance Task (PVT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-08-06 |
| Est. Completion | 2024-03-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04403165
The ClinicalTrials.gov registry entry for NCT04403165 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Nocturnal polysomnography (NPSG) is the first listed.
NCT04403165 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04403165 about?
NCT04403165 is a clinical study titled "Locus-coeruleus Function in Normal Elderly and AD Risk". Growing evidence suggests that Alzheimer's disease (AD) pathological changes begin decades before clinical symptoms and tau abnormalities in the locus coeruleus (LC) can be observed since midlife. We have previously demonstrated functional vulnerability of the LC to aging and stress, as well as an a...
What is the current status of trial NCT04403165?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2020-08-06. Estimated completion is 2024-03-26.
What interventions are being tested in trial NCT04403165?
The interventions under investigation include: Nocturnal polysomnography (NPSG) (PROCEDURE), Lumbar Puncture (LP) (PROCEDURE), PET-MR measurement with a norepinephrine transporter (NET)-selective radiotracer (S,S)-[11C]Omethylreboxetine ([11C]MRB) (OTHER), Psychomotor Vigilance Task (PVT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04403165?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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