NCT04403165Completed
Locus-coeruleus Function in Normal Elderly and AD Risk
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 21 May 2020
- Start date
- 6 Aug 2020
- Primary completion date
- 26 Mar 2024
- Lead sponsor
- NYU Langone Health
- Diseases
- Alzheimer disease
- NCT number
- NCT04403165
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 6 Aug 2020 to the primary completion date, 26 Mar 2024
- 2 sites 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
- Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
- Taking Coumadin/warfarin and/or medications affecting cognition or sleep.
Other illness
- History of brain tumor, MRI evidence of brain damage or brain disease including significant trauma, hydrocephalus, seizures, stroke, mental retardation or other serious neurological disorder (e.g. Parkinson's disease or other movement disorders).
- Significant history of alcoholism or drug abuse.
- Significant history of psychiatric illness (e.g., schizophrenia, bipolar, PTSD, or life-long history of major depression).
- Insulin dependent diabetes.
- Evidence of clinically relevant cardiac, pulmonary, endocrine or hematological conditions.
- Physical impairment of such severity as to adversely affect the validity of psychological testing.
- Failure to complete all study visit within 4 months
Age
- History of a first-degree family member with early onset (age \<60 years) dementia.
Other
- Geriatric Depression Scale (short form)\>6.
- Irregular sleep-wake rhythms (based on the actigraphy recordings) or significant OSA (AHI4%≥15).
Who the study is looking for
- Male and female subjects with normal cognition and 55-75 years of age will be enrolled.
- Subjects will be within normal limits on neurological and psychiatric examinations.
- All subjects enrolled will have a CDR of 0. This will be evaluated through a clinical interview administered by a study physician (informant interview will not be required).
- All subjects will have had a minimum of 12 years of education.
Age in the registry: 55 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Grossman School of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine Mount Sinai 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.