Amyloid-betaNCT02063217

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

A study testing Sodium Oxybate and Sleep deprivation in people with Amyloid-beta, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Amyloid-beta
What is being tested?: Sodium Oxybate and Sleep deprivation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Dec 2013to Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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,

Show all 30Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University Medical School
St Louis, Missouri, 63108

Other trials in United States

About this study

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.

Read the detailed description

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).

Conditions: Amyloid-beta
Being tested: Sodium Oxybate, Sleep deprivation
Medical subject headings: Plaque, Amyloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium OxybateDrug
Also called Xyrem
Sodium oxybate h.s.
Sleep deprivationBehavioural
36hr sleep deprivation

Study groups in NCT02063217
Study group	Role	What they receive
Sleep Induction	Experimental	7.5 grams of sodium oxybate Receives: Drug: Sodium Oxybate
Sleep Deprivation	Experimental	Sleep deprivation for up to 36 hours with no naps or other sleep periods Receives: Behavioral: Sleep deprivation
Control	No intervention	Participant will sleep as normal under the same controlled conditions in a clinical research unit

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Jul 2016

First posted14 Feb 2014 (estimated)
Study startDec 2013
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Amyloid-betaStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02063217
Sponsor's protocol ID: 201304030
Other IDs: P50AG005681-30
Status last verified: Mar 2018
First submitted: 29 Jan 2014
Last updated: 26 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amyloid-beta trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modulation of CSF Amyloid-beta Concentrations Via Behavioral Sleep Deprivation and Pharmacological Sleep Induction
ClinicalTrials.gov ID: NCT02063217
Acronym / sponsor ID: 201304030
Conditions: Amyloid-beta
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Aging (NIA)
Study start: Dec 2013
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 14 Feb 2014 (estimated)
Results: Posted 26 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Sleep Induction	Experimental	Drug: Sodium Oxybate7.5 grams of sodium oxybate
Sleep Deprivation	Experimental	Behavioral: Sleep deprivationSleep deprivation for up to 36 hours with no naps or other sleep periods
Control	No intervention	–Participant will sleep as normal under the same controlled conditions in a clinical research unit

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (30 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium OxybateAlso: XyremSodium oxybate h.s.	Drug	Sleep Induction
Sleep deprivation36hr sleep deprivation	Behavioural	Sleep Deprivation

Primary outcome

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

Results and safety

Results posted to the registry on 26 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sleep Induction	12	11
Sleep Deprivation	12	12
Control	12	12

Primary outcome: 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

Time frame: Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00. Mean (Standard Error). Unit: percent increase from mean baseline

Measure	Sleep Induction n = 11	Sleep Deprivation n = 12	Control n = 12
Value	113 (5.7)	123 (6.6)	106 (5.6)

Sleep Deprivation vs Control: Mean Difference (Net): 17, p = 0.07, Mixed Models Analysis
Sleep Induction vs Control: Mean Difference (Net): 7, p = 1.0, Mixed Models Analysis

Population analysed: Participants in good general health who had CSF collected every 2 hours for 36 hours while undergoing with sleep deprivation, sleep induction with drug, or control conditions.

Adverse events

Time frame: Adverse events were recorded from the start of the participant confinement visits to the Clinical Research Unit when the lumbar catheter was placed and cerebrospinal fluid collected. Adverse event recording continued through a 48 hour telephone follow-up period. Total reporting period was 6 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sleep Induction	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
Sleep Deprivation	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Control	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brendan Lucey, MD principal investigator

Washington University Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sodium Oxybate and Sleep deprivation in people with Amyloid-beta, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02063217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.