Sleep Quality and Amyloid-Beta Kinetics

Not Applicable

Completed

Conditions: Amyloid-beta

Interventions: Drug: Suvorexant
Drug: Placebo

Registration Number: NCT03077620

Lead Sponsor: Washington University School of Medicine

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.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

Inclusion Criteria

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

Exclusion Criteria

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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Poor sleep group treatment 1	Suvorexant	10mg Suvorexant tablet h.s. for two consecutive nights
Good sleep group	Placebo	Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
Poor sleep group control	Placebo	Participant 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	Suvorexant	20mg Suvorexant tablet h.s. for two consecutive nights

Primary Outcome Measures

Name	Time	Method
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	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	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)

Secondary Outcome Measures