NCT02063217

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

April 26, 2018

Completed
Last Updated

April 26, 2018

Status Verified

March 1, 2018

Enrollment Period

2.6 years

First QC Date

January 29, 2014

Results QC Date

July 26, 2017

Last Update Submit

March 26, 2018

Conditions

Amyloid-beta

Outcome Measures

Primary Outcomes (1)

  • Percent Increase From Mean Baseline (07:00 to 19:00) of Cerebrospinal Fluid (CSF) Amyloid Beta During Sleep Induction and Sleep Deprivation Between 01:00 and 11:00 From Baseline

    Overnight (01:00 to 11:00) differences in CSF amyloid beta from baseline (07:00 to 19:00) between 1) sleep-deprived and control participants and 2) sleep-induced and control participants.

    Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00

Study Arms (3)

Sleep Induction

EXPERIMENTAL

7.5 grams of sodium oxybate

Drug: Sodium Oxybate

Sleep Deprivation

EXPERIMENTAL

Sleep deprivation for up to 36 hours with no naps or other sleep periods

Behavioral: Sleep deprivation

Control

NO INTERVENTION

Participant will sleep as normal under the same controlled conditions in a clinical research unit

Interventions

Sodium OxybateDRUG

Sodium oxybate h.s.

Also known as: Xyrem
Sleep Induction
Sleep deprivationBEHAVIORAL

36hr sleep deprivation

Sleep Deprivation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University Medical School

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Plaque, Amyloid

Interventions

Sodium Oxybate

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxybutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy Acids

Results Point of Contact

Title
Dr. Brendan Lucey
Organization
Washington University School of Medicine
luceyb@wustl.edu
314-362-4342

Study Officials

  • Brendan Lucey, MD

    Washington University Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2014

First Posted

February 14, 2014

Study Start

December 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 26, 2018

Results First Posted

April 26, 2018

Record last verified: 2018-03

Locations

US(1)