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Protocol Details

Characterization of Brain Amyloid-beta (A-beta) Retention During Wakefulness And Following Emergence From Sleep In Healthy Subjects

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-AA-0059

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

18 F florbetaben;
Sleep Deprivation;
rested wakefulness;
glymphatic system

Recruitment Keyword(s)

None

Condition(s)

Normal Physiology

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Radiation: [18F]florbetaben
Radiation: [18F]florbetaben

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

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.

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Eligibility

INCLUSION CRITERIA:

1. Male or females.

2. Young group (18-40 years of age)

3. Older group (>40 years of age)

4. Ability to provide written informed consent

EXCLUSION CRITERIA:

1. 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.

2. 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.

3. Head trauma with loss of consciousness for more than 30 minutes as determined by self-report and/or medical history.

4. Subjects with problematic insomnia as determined by self-report (reports having trouble sleeping on most days).

5. 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.

6. 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.

7. Current DSM 5 diagnosis of affective disorder, addiction (other than nicotine of caffeine), PTSD, or schizophrenia.

8.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.

9. Severe medical problems that can permanently impact brain function (e.g., problems of the CNS; cardiovascular; metabolic, autoimmune, endocrine) as determined by history and clinical exam.

10. Individuals with a medical history of a neurodegenerative disease.

11. Heavy alcohol users. Heavy alcohol users are those individuals who consume more than 5 drinks in one seating (if males) or more than 4 drinks in one seating (if females) more than twice a week will be excluded.

12. Uncontrolled hypertension.

13. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces as determined by the self-report checklist.

14. Fear of enclosed spaces (claustrophobia) as determined by self-report and medical history.

15. Cannot lie comfortably flat on the back for up to 2 hours in the MRI scanner as determined by self-report.

16. Body weight > 250 kg. This is the upper limit that the bed of the MR scanner can accommodate (clinical exam).

17. Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.

18. Study investigators and staff, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Gene-Jack Wang, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
BG 10 RM B2L124
10 CENTER DR
BETHESDA MD 20814
(301) 496-5012
gene-jack.wang@nih.gov

Gene-Jack Wang, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
BG 10 RM B2L124
10 CENTER DR
BETHESDA MD 20814
(301) 496-5012
gene-jack.wang@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02669225

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