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



Status:Completed
Conditions:Insomnia Sleep Studies, Hematology
Therapuetic Areas:Hematology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:4/28/2018
Start Date:December 2013
End Date:July 2016

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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.

The purpose of this research study is to investigate whether or not increasing or decreasing
duration of sleep over one night will change the concentration of amyloid-beta in cerebral
spinal fluid (CSF).

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
We found this trial at
1
site
Saint Louis, Missouri 63110
Principal Investigator: Brendan Lucey, MD
Phone: 314-747-3819
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mi
from
Saint Louis, MO
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