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Life sciences · Interventional Study
ClinicalTrials.gov · November 6, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT04403165). This is a study registration, not published results. Lead sponsor: NYU Langone Health. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 34 participants (ACTUAL). Conditions: Alzheimer Disease. 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). Primary outcome measures: Methylreboxetine (MRB)-LC Mean Standardized Uptake Value Ratio (SUVR) Values , Visit 4 (1-4 weeks after LP that occurred on day 14); Total Rapid Eye Movement (REM) Duration (Min) , Visit 3 (1-4 weeks after Visit 2 which occurred on day 9); Percentage of Time Spent in REM Sleep , Visit 3 (1-4 weeks after Visit 2 which occurred on day 9); Percentage of REM Runs That Are Less Than 5 Minutes , Visit 3 (1-4 weeks after Visit 2 which occurred on day 9); Percentage of REM Runs That Are Greater Than or Equal to 5 Minutes , Visit 3 (1-4 weeks after Visit 2 which occurred on day 9); Percentage of REM Runs That Are Greater Than or Equal to 10 Minutes , Visit 3 (1-4 weeks after Visit 2 which occurred on day 9); Percentage of Correct Responses on the Picture Test , Visit 3 (1-4 weeks after Visit 2 which occurred on day 9); Number of Sleep Spindles That Occur Per Minute During the N2 Stage of Sleep (N2 Spindle Density) , Visit 3 (1-4 weeks after Visit 2 which occurred on day 9); Mean Psychomotor Vigilance Test (PVT) Reaction Time , Visit 3 (1-4 weeks after Visit 2 which occurred on day 9); Picture Test Response Time , Visit 3 (1-4 weeks after Visit 2 which occurred on day 9). Brief 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.