Sleep Quality and Amyloid-Beta Kinetics

NCT03077620 | Completed Results DMC

• 1 other identifier: 201602165
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to change the concentration of amyloid-beta in human cerebrospinal fluid (CSF) by modification of sleep efficiency.

Conditions

Amyloid-beta

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  36 hours of CSF collection

Study Arms (4)

Poor sleep group treatment 1

EXPERIMENTAL

10mg Suvorexant tablet h.s. for two consecutive nights

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.

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.

Drug: Placebo

Poor sleep group treatment 2

EXPERIMENTAL

20mg Suvorexant tablet h.s. for two consecutive nights

Drug: Suvorexant

Interventions

Suvorexant DRUG

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.

Also known as: Belsomra

Poor sleep group treatment 1; Poor sleep group treatment 2

Placebo DRUG

Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.

Also known as: sugar pill

Good sleep group; Poor sleep group control

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63144, United States

Location

MeSH Terms

Conditions

Plaque, Amyloid

Interventions

suvorexant; Sugars

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Dr. Brendan Lucey
• Organization: Washington University in St Louis School of Medicine

luceyb@wustl.edu

314-747-3805

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: October 17, 2016
• First Posted: March 13, 2017
• Study Start: November 1, 2016
• Primary Completion: March 28, 2021
• Study Completion: March 30, 2021
• Last Updated: May 17, 2022
• Results First Posted: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)