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NCT02669225 · ClinicalTrials.gov registry record · Early Phase 1
Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People
A Early Phase 1 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
NCT02669225 is a Early Phase 1 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 22 participants.
The verdict
NCT02669225, a Early Phase 1 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
Study 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 lie on a table that slides into the cylinder. A device called a coil will be placed over the head. Participants will do a task on a computer screen in the scanner. Participants will have tests of thinking, memory, and attention. They may be interviewed, complete questionnaires, take pen-and-paper or computer tests, and perform simple actions.
Interventions
- OTHER [18F]florbetaben
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2016-05-02 |
| Est. Completion | 2018-07-11 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02669225
The ClinicalTrials.gov registry entry for NCT02669225 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [18F]florbetaben is the first listed.
NCT02669225 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02669225 about?
NCT02669225 is a clinical study titled "Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People". 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...
What is the current status of trial NCT02669225?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2016-05-02. Estimated completion is 2018-07-11.
What interventions are being tested in trial NCT02669225?
The interventions under investigation include: [18F]florbetaben (OTHER).
Who is sponsoring clinical trial NCT02669225?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
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