Clinical Trial: Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Characterization of Brain Amyloid-beta (A-beta) Retention During Wakefulness And Following Emergence From Sleep In Healthy Subjects
Brief Summary:
Background:
Brain activity creates waste products. The body s glymphatic system removes this waste, especially during sleep. One brain waste product is amyloid-beta (Ab). It plays a role in Alzheimer s disease. Researchers want to study the effect of sleep on Ab in the brain.
Objective:
To see if sleep affects the amount of waste product removed from the brain.
Eligibility:
Healthy people at least 18 years of age.
Design:
Participants will be screened with a medical history, physical exam, and blood and urine tests. They will answer questions about drug use, psychiatric history, and family history of alcoholism or drug use. Participants will complete an MRI screening questionnaire.
Participants will stay in the clinic overnight two times. On one night they will sleep through the night. On the other night they will be kept awake all night. These overnight visits can happen in any order.
Participants will wear 2 activity monitors, on the wrist and the ankle.
Participants will have positron emission tomography (PET) scans. A small amount of a radioactive chemical will be injected through an intravenous (IV) catheter. Participants will lie on a bed that slides into the scanner. A cap or a special mask may be placed on the participant s head.
Participants will have magnetic resonance imaging (MRI) scans. The MRI scanner is a metal cylinder in a strong magnetic field. Participants will l
Detailed Summary:
Objective:
To assess if there are differences in [18F]florbetaben uptake following the first 120 minutes of its injection (reflecting amyloid-beta or Ab load and/or docked Ab) in subjects during rested wakefulness (RW) after normal sleep compared to wakefulness after 24 hrs of sleep deprivation (SD). Specifically, we hypothesize that during RW after a normal night s sleep there will be less [18F]florbetaben binding measured as distribution volume ratios (DVR) in precuneus relative to cerebellum (reflecting normal brain clearing of Ab overnight) when compared to wakefulness after SD, which would interfere with Ab removal from the brain s interstitial space. Though we will be measuring Ab in whole brain our analysis will focus in precuneus since this is the brain region that shows the higher levels of Ab accumulation in contrast to cerebellum where there is no accumulation of Ab. Therefore, overall Ab load in precuneus (as reflected by [18F]florbetaben DVR) will be lower during RW compared to SD. MRI and 1H-MRS will be used secondarily to assess if there are differences in connectivity, function and neurochemistry in precuneus between RW and SD. Because the rate of CSF production as
well as Ab clearance from CSF differs as a function of age the current study will also allow us to assess if the higher Ab brain levels reported in older than in younger individuals reflect greater Ab clearance in younger than older individuals.
Study population:
Two groups consisting of healthy young adults (18 - 40 years of age) and healthy older adults (>40 years of age). Males and females will be included.
Design:
Observational study. We will
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Current Primary Outcome: Differences in the mean retention of [18F]florbetaben [ Time Frame: Study Completion ]
Original Primary Outcome: Same as current
Current Secondary Outcome: For the results obtained with the MRI scan [ Time Frame: completion of study ]
Original Secondary Outcome: Same as current
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: January 29, 2016
Date Started: January 20, 2016
Date Completion: December 31, 2022
Last Updated: May 12, 2017
Last Verified: October 3, 2016
