Status:
COMPLETED
Locus-coeruleus Function in Normal Elderly and AD Risk
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Eligibility:
All Genders
55-75 years
Phase:
NA
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 ...
Detailed Description
The purpose of this study is three-fold: to test whether lower NET availability in the LC is associated with: first, CSF tau levels typical of preclinical stages of AD (Aim 1); second, reduced REM and...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- Geriatric Depression Scale (short form)\>6.
- 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.
- Any prosthetic devices (e.g., pacemaker or surgical clips) that constitutes a hazard for MRI imaging.
- History of a first-degree family member with early onset (age \<60 years) dementia.
- Irregular sleep-wake rhythms (based on the actigraphy recordings) or significant OSA (AHI4%≥15).
- Taking Coumadin/warfarin and/or medications affecting cognition or sleep.
- Failure to complete all study visit within 4 months
Key Trial Info
Start Date :
August 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04403165
Start Date
August 6 2020
End Date
March 26 2024
Last Update
December 2 2025
Active Locations (2)
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1
NYU Grossman School of Medicine
New York, New York, United States, 10016
2
Icahn School of Medicine Mount Sinai
New York, New York, United States, 10029