Amyloid-betaNCT03077620

Sleep Quality and Amyloid-Beta Kinetics

A study testing Suvorexant 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) by modification of sleep efficiency. Read more about this study

Who is it for?: Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Amyloid-beta
What is being tested?: Suvorexant
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Nov 2016to 30 Mar 2021
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 45 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 45-65 years
Any sex
Any race/ethnicity
Mini-Mental Status Examination score (MMSE) >=27
Sleep efficiency measured by actigraphy to determine good sleeper or poor sleeper

Who cannot join

Cognitive impairment as determined by history of MMSE < 27
Inability to speak or understand English
BMI >35
Any sleep disorders other than insomnia
history of sleep-disordered breathing
STOP-Bang score > 3

Show all 27Show fewer

History or reported symptoms suggestive of restless legs syndrome, narcolepsy or other sleep disorders
Sleep schedule outside the range of bedtime 8PM-12AM and wake time 4AM-9AM
Contraindication to lumbar catheter (anticoagulants; bleeding disorder; allergy to lidocaine or disinfectant; prior central nervous system or lower back surgery)
Cardiovascular disease requiring medication except for controlled hypertension (PI discretion)
Stroke
Hepatic or renal impairment
Pulmonary disease (PI discretion)
Type 1 diabetes
HIV or AIDS
Neurologic or psychiatric disorder requiring medication (PI discretion)
Alcohol or tobacco use (PI discretion)
Use of sedating medications
Inability to get out of bed independently
Abnormal movement of the non-dominant arm (would affect actigraphy data in unpredictable ways)
Abnormal physical examination
Current pregnancy
History of migraine headaches (PI discretion)
History of drug abuse in the past 6 months
Urinary or fecal incontinence
Difficulty sleeping in an unfamiliar environment (good sleep quality group only)
History or presence of any clinically significant medication condition, behavioral or psychiatric condition (including suicidal ideation), or surgical history based on medical record or patient report that could affect the safety of the subject or interfere with study assessments or in the judgment of the PI is not a good candidate

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63144

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) by modification of sleep efficiency.

Read the detailed description

The purpose of the study is to investigate whether or not increasing sleep efficiency will change the concentration of amyloid-beta in cerebrospinal fluid (CSF).

Conditions: Amyloid-beta
Being tested: Suvorexant, Placebo
Medical subject headings: Plaque, Amyloid

What participants receive

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

SuvorexantDrug
Also called Belsomra
Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.
PlaceboDrug
Also called sugar pill
Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.

Study groups in NCT03077620
Study group	Role	What they receive
Poor sleep group treatment 1	Experimental	10mg Suvorexant tablet h.s. for two consecutive nights Receives: Drug: Suvorexant
Poor sleep group control	Placebo comparator	Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Receives: Drug: Placebo
Good sleep group	Placebo comparator	Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit. Receives: Drug: Placebo
Poor sleep group treatment 2	Experimental	20mg Suvorexant tablet h.s. for two consecutive nights Receives: Drug: Suvorexant

What is being measured

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

Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml
Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency (Poor sleep group control) compared to those with good sleep efficiency (Good sleep group)
Measured: 36 hours of CSF collection
Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Treated With Placebo, Suvorexant 10 mg, or Suvorexant 20 mg as Measured by ng/ml
Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency who were treated with placebo (Poor sleep group control), Suvorexant 10 mg (Poor sleep group treatment 1), and Suvorexant 20 mg (Poor sleep group treatment 2)
Measured: 36 hours of CSF collection

Timeline

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

Nov 201630 Mar 2021

First posted13 Mar 2017
Study startNov 2016
Primary completion28 Mar 2021
Study completion30 Mar 2021

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: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03077620
Sponsor's protocol ID: 201602165
Status last verified: May 2022
First submitted: 17 Oct 2016
Last updated: 17 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep Quality and Amyloid-Beta Kinetics
ClinicalTrials.gov ID: NCT03077620
Acronym / sponsor ID: 201602165
Conditions: Amyloid-beta
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: Nov 2016 (actual)
Primary completion: 28 Mar 2021 (actual)
Study completion: 30 Mar 2021 (actual)
First posted: 13 Mar 2017 (actual)
Results: Posted 17 May 2022

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) by modification of sleep efficiency.

Detailed description

The purpose of the study is to investigate whether or not increasing sleep efficiency will change the concentration of amyloid-beta in cerebrospinal fluid (CSF).

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
Poor sleep group treatment 1	Experimental	Drug: Suvorexant10mg Suvorexant tablet h.s. for two consecutive nights
Poor sleep group control	Placebo comparator	Drug: PlaceboParticipant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
Good sleep group	Placebo comparator	Drug: PlaceboParticipant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
Poor sleep group treatment 2	Experimental	Drug: Suvorexant20mg Suvorexant tablet h.s. for two consecutive nights

Who may qualify

Ages: 45 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age 45-65 years
Any sex
Any race/ethnicity
Mini-Mental Status Examination score (MMSE) >=27
Sleep efficiency measured by actigraphy to determine good sleeper or poor sleeper

Key exclusion criteria (27 listed)

Cognitive impairment as determined by history of MMSE < 27
Inability to speak or understand English
BMI >35
Any sleep disorders other than insomnia
history of sleep-disordered breathing

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
SuvorexantAlso: BelsomraParticipants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.	Drug	Poor sleep group treatment 1, Poor sleep group treatment 2
PlaceboAlso: sugar pillParticipants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.	Drug	Good sleep group, Poor sleep group control

Primary outcome

Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml
Time frame: 36 hours of CSF collection
Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency (Poor sleep group control) compared to those with good sleep efficiency (Good sleep group)
Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Treated With Placebo, Suvorexant 10 mg, or Suvorexant 20 mg as Measured by ng/ml
Time frame: 36 hours of CSF collection
Mean difference in amyloid-beta-42 concentration between individuals with poor sleep efficiency who were treated with placebo (Poor sleep group control), Suvorexant 10 mg (Poor sleep group treatment 1), and Suvorexant 20 mg (Poor sleep group treatment 2)

Results and safety

Results posted to the registry on 17 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Poor Sleep Group Control	14	13
Poor Sleep Group Treatment 1	14	13
Poor Sleep Group Treatment 2	14	12
Good Sleep Group	6	6

Primary outcome: Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml

Time frame: 36 hours of CSF collection. Mean (Standard Deviation). Unit: ng/ml

Measure	Poor Sleep Group Control n = 13	Good Sleep Group n = 5
Amyloid-beta-42 concentration at hour 0 (ng/ml)	0.573 (0.206)	0.623 (0.189)
Amyloid-beta-42 concentration at hour 2 (ng/ml)	0.600 (0.232)	0.520 (0.168)
Amyloid-beta-42 concentration at hour 4 (ng/ml)	0.583 (0.180)	0.528 (0.171)
Amyloid-beta-42 concentration at hour 6 (ng/ml)	0.573 (0.155)	0.542 (0.174)
Amyloid-beta-42 concentration at hour 8 (ng/ml)	0.598 (0.189)	0.548 (0.155)
Amyloid-beta-42 concentration at hour 10 (ng/ml)	0.602 (0.173)	0.537 (0.149)
Amyloid-beta-42 concentration at hour 12 (ng/ml)	0.635 (0.205)	0.536 (0.129)
Amyloid-beta-42 concentration at hour 14 (ng/ml)	0.645 (0.203)	0.556 (0.126)

Poor Sleep Group Control vs Good Sleep Group: Mean Difference (Final Values): 0.119 (95% CI -0.017 to 0.256), p = 0.05, Mixed Models Analysis

Primary outcome: Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Treated With Placebo, Suvorexant 10 mg, or Suvorexant 20 mg as Measured by ng/ml

Time frame: 36 hours of CSF collection. Mean (Standard Deviation). Unit: ng/ml

Measure	Poor Sleep Group Control n = 13	Poor Sleep Group Treatment 1 n = 13	Poor Sleep Group Treatment 2 n = 12
Amyloid-beta-42 concentration at hour 0 (ng/ml)	0.573 (0.206)	0.519 (0.171)	0.648 (0.146)
Amyloid-beta-42 concentration at hour 2 (ng/ml)	0.600 (0.232)	0.520 (0.182)	0.648 (0.129)
Amyloid-beta-42 concentration at hour 4 (ng/ml)	0.583 (0.180)	0.536 (0.205)	0.679 (0.129)
Amyloid-beta-42 concentration at hour 6 (ng/ml)	0.573 (0.155)	0.544 (0.207)	0.678 (0.139)
Amyloid-beta-42 concentration at hour 8 (ng/ml)	0.598 (0.189)	0.546 (0.217)	0.670 (0.122)
Amyloid-beta-42 concentration at hour 10 (ng/ml)	0.602 (0.173)	0.544 (0.222)	0.679 (0.124)
Amyloid-beta-42 concentration at hour 12 (ng/ml)	0.635 (0.205)	0.558 (0.222)	0.660 (0.121)
Amyloid-beta-42 concentration at hour 14 (ng/ml)	0.645 (0.203)	0.583 (0.223)	0.679 (0.111)

Poor Sleep Group Control vs Poor Sleep Group Treatment 1: Mean Difference (Final Values): 0.004 (95% CI -0.078 to 0.087), p = 0.05, Mixed Models Analysis
Poor Sleep Group Control vs Poor Sleep Group Treatment 2: Mean Difference (Final Values): 0.033 (95% CI -0.051 to 0.117), p = 0.05, Mixed Models Analysis

Adverse events

Time frame: Adverse event data was collected from when the participants were consented into the study until 48 hours after the lumbar catheter was removed (~3 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Poor Sleep Group Control	0 of 13 (0%)	10 of 13 (76.9%)	0 of 13
Poor Sleep Group Treatment 1	0 of 13 (0%)	10 of 13 (76.9%)	0 of 13
Poor Sleep Group Treatment 2	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Good Sleep Group	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 Suvorexant 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 5 inclusion and 27 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 17 May 2022. 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. Some participants in this study may receive a placebo. 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 17 May 2022). 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?

Difference in Amyloid-beta (Abeta) Concentration in the CSF (Cerebral Spinal Fluid) of Individuals With Poor Sleep Efficiency Compared to Those With Good Sleep Efficiency as Measured by ng/ml (time frame: 36 hours of CSF collection). The study lists 2 primary outcomes in all. 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 NCT03077620.

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 17 May 2022.