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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: Completed NA study, sponsored by NYU Langone Health.
NCT04403165 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT04403165 record still lists
NCT04403165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Nocturnal polysomnography (NPSG) is the first listed.
NCT04403165 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04403165's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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