Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) through modulation of the sleep-wake cycle.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborators: National Institute on Aging (NIA); National Institutes of Health (NIH)
• Treatments: Sodium Oxybate

Criteria

Inclusion Criteria:

• cognitively normal or CDR 0

• negative for amyloid deposition by PET Pittsburgh Compound-B (PIB) imaging or CSF amyloid-beta-42 concentration

• Age 18-60

• Average reported sleep time 6-10hrs

Exclusion Criteria:

• diagnosis of a sleep disorder such as sleep apnea, narcolepsy, or restless leg syndrome

• positive ambulatory sleep study for obstructive sleep apnea (AHI > 5 respiratory events per hour) that will be performed as part of initial screening prior to enrollment

• Clinical Dementia Rating (CDR) > 0

• tremor or other neurologic injury in the non-dominant upper extremity (such as stroke or tremor) that would prevent the use of actigraphy

• current sleep walking or other sleep parasomnia

• diagnosis and treatment of stroke, myocardial infarction or heart attack,

• coronary artery disease, atrial fibrillation, or congestive heart failure

• diagnosis and treatment of asthma or Chronic Obstructive Pulmonary Disease (COPD)

• diagnosis and treatment of bipolar disorder, major depression, or Schizophrenia

• current urinary or fecal incontinence

• currently on a low salt diet

• diagnosis and treatment of a neurologic disorder such as Parkinson's disease, epilepsy, multiple sclerosis

• currently taking any blood thinner medications such as warfarin, Plavix, or Aspirin

• kidney disease resulting in renal impairment

• liver disease resulting in hepatic dysfunction

• Pregnancy

• currently taking sedating medications such as benzodiazepines

• alcohol use at bedtime

• tobacco use

• BMI >40

• contraindication to lumbar puncture

• diabetes

• sleep schedule outside the range of bedtime: 8pm-12am and waketime 4am-8am

• self reported difficulty sleeping in an unfamiliar environment

• use of sedative-hypnotic medications

• inability to get in and out of bed

• history or presence of any clinically significant medical condition, behavioral or psychiatric disorder, or surgical history based on medical record or patient report

• history of drug abuse within the past 6 months

• positive score on 2 or more categories on the Berlin questionnaire

• participation in another investigational medicinal product or investigational device within the last 30 days