Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People (NCT02669225) | Clinical Trial Compass
CompletedEarly Phase 1
Brain Amyloid- Retention During Wakefulness and Following Emergence From Sleep in Healthy People
United States22 participantsStarted 2016-05-02
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or females.
. Young group (18-40 years of age)
. Older group (\>40 years of age)
. Ability to provide written informed consent
Exclusion criteria
. Pregnant and/or breast feeding. Females of childbearing potential must have negative urine pregnancy test and not be currently breastfeeding. Post-menopausal or surgically sterile (tubal ligation or hysterectomy) females satisfy these criteria.
. Positive urine drug test for controlled substances (cocaine, methamphetamine, amphetamines, opioids, cannabinoids, benzodiazepines and barbiturates) on each visit involving imaging studies and/or neuropsychological assessment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied how sleep deprivation affects amyloid buildup in the brain using a radioactive PET tracer called florbetaben — given that it's a Phase 1 study in healthy volunteers, what does that mean for what we actually know so far about whether poor sleep meaningfully raises my personal risk for amyloid-related disease?
2The trial compared younger and older healthy participants to see if age affects how well the brain clears amyloid during sleep — based on my age and health history, is this something my doctor thinks is relevant to watch in my own situation?
3Since this study used sleep deprivation as the variable, should I be talking to my doctor about evaluating the quality of my own sleep as part of monitoring my brain health, and are there any established interventions worth considering?
4This trial is now completed — has my doctor seen any published results from it, and do those findings change how they think about the relationship between sleep and brain amyloid in patients like me?
5Given that this was an observational study in healthy people rather than a treatment trial, what would my doctor recommend as a next step if I'm concerned about amyloid accumulation — are there other trials or standard evaluations that might be more directly relevant to my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
(1) To assess if there are differences in [18F] florbetaben binding(reflecting A load) in subjects after SD compared to RW when measured in the morning.
Timeframe: end of study
2
(2) To assess if there are differences in brain A accumulation during RW and SD and to assess if there are differences in brain Aclearance (comparisons of RW versus SD) between young and older participants.
Timeframe: end of study
Trial details
NCT IDNCT02669225
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
. Head trauma with loss of consciousness for more than 30 minutes as determined by self-report and/or medical history.
. Subjects with problematic insomnia as determined by self-report (reports having trouble sleeping on most days).
. Subjects with any of the following: narcolepsy, obstructive sleep apnea (OSA) and/or abnormal sleeping patterns (including but not limited to those who use a CPAP machine, sleeping during the day, using medication to fall asleep, sleeps less than 5 hours per night, night shift workers) as determined by self-report and/or medical history.
. Use, in the past two weeks, of psychoactive medications (four weeks for fluoxetine) or medications that may affect brain function (including but not limited to opioid analgesics, antidepressants, antipsychotics, benzodiazepines and barbiturates, stimulants) as determined by self-report and/or medical history.
. Current DSM 5 diagnosis of affective disorder, addiction (other than nicotine of caffeine), PTSD, or schizophrenia.
. Individuals with cognitive impairment as identified with a score of lower than 24 in the MMSE will be excluded. Further, individuals with impairment sufficient to affect consent capacity even if MMSE is less than 24 will be excluded. We will consult the Ability to Consent Assessment Team (ACAT) in those whose capacity to consent may be questionable.