Amyloid-beta
Conditions
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).
Interventions
DRUGSuvorexant
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.
DRUGPlacebo
Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Poor Sleep Group Control Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. | 13 |
| Poor Sleep Group Treatment 1 10mg Suvorexant tablet h.s. for two consecutive nights
Suvorexant: 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. | 13 |
| Poor Sleep Group Treatment 2 20mg Suvorexant tablet h.s. for two consecutive nights
Suvorexant: 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. | 12 |
| Good Sleep Group Participant will receive placebo for two consecutive nights and sleep as normal under the same controlled conditions in a clinical research unit.
Placebo: Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit. | 5 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 |
| Overall Study | Unable to place lumbar catheter | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Poor Sleep Group Treatment 1 | Poor Sleep Group Treatment 2 | Good Sleep Group | Poor Sleep Group Control | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 12 Participants | 5 Participants | 13 Participants | 43 Participants |
| Age, Continuous | 56.95 years STANDARD_DEVIATION 4.35 | 54.30 years STANDARD_DEVIATION 5.66 | 59.18 years STANDARD_DEVIATION 7.24 | 55.94 years STANDARD_DEVIATION 6.1 | 56.23 years STANDARD_DEVIATION 5.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 1 Participants | 0 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 11 Participants | 5 Participants | 10 Participants | 35 Participants |
| Region of Enrollment United States | 13 Participants | 12 Participants | 5 Participants | 13 Participants | 43 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 5 Participants | 8 Participants | 31 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 0 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 | 0 / 12 | 0 / 6 |
| other Total, other adverse events | 10 / 13 | 10 / 13 | 10 / 12 | 4 / 6 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 | 0 / 12 | 0 / 6 |
Outcome results
Primary
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)
Time frame: 36 hours of CSF collection
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 10 (ng/ml) | 0.602 ng/ml | Standard Deviation 0.173 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 20 (ng/ml) | 0.680 ng/ml | Standard Deviation 0.195 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 6 (ng/ml) | 0.573 ng/ml | Standard Deviation 0.155 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 22 (ng/ml) | 0.674 ng/ml | Standard Deviation 0.203 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 12 (ng/ml) | 0.635 ng/ml | Standard Deviation 0.205 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 24 (ng/ml) | 0.691 ng/ml | Standard Deviation 0.177 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 4 (ng/ml) | 0.583 ng/ml | Standard Deviation 0.18 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 26 (ng/ml) | 0.674 ng/ml | Standard Deviation 0.198 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 14 (ng/ml) | 0.645 ng/ml | Standard Deviation 0.203 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 28 (ng/ml) | 0.692 ng/ml | Standard Deviation 0.191 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 8 (ng/ml) | 0.598 ng/ml | Standard Deviation 0.189 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 30 (ng/ml) | 0.660 ng/ml | Standard Deviation 0.183 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 16 (ng/ml) | 0.661 ng/ml | Standard Deviation 0.196 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 32 (ng/ml) | 0.652 ng/ml | Standard Deviation 0.194 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 2 (ng/ml) | 0.600 ng/ml | Standard Deviation 0.232 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 34 (ng/ml) | 0.682 ng/ml | Standard Deviation 0.201 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 18 (ng/ml) | 0.659 ng/ml | Standard Deviation 0.184 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 36 (ng/ml) | 0.743 ng/ml | Standard Deviation 0.183 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 0 (ng/ml) | 0.573 ng/ml | Standard Deviation 0.206 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 36 (ng/ml) | 0.625 ng/ml | Standard Deviation 0.143 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 0 (ng/ml) | 0.623 ng/ml | Standard Deviation 0.189 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 2 (ng/ml) | 0.520 ng/ml | Standard Deviation 0.168 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 4 (ng/ml) | 0.528 ng/ml | Standard Deviation 0.171 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 6 (ng/ml) | 0.542 ng/ml | Standard Deviation 0.174 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 8 (ng/ml) | 0.548 ng/ml | Standard Deviation 0.155 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 10 (ng/ml) | 0.537 ng/ml | Standard Deviation 0.149 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 12 (ng/ml) | 0.536 ng/ml | Standard Deviation 0.129 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 14 (ng/ml) | 0.556 ng/ml | Standard Deviation 0.126 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 16 (ng/ml) | 0.578 ng/ml | Standard Deviation 0.139 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 18 (ng/ml) | 0.579 ng/ml | Standard Deviation 0.131 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 20 (ng/ml) | 0.568 ng/ml | Standard Deviation 0.123 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 22 (ng/ml) | 0.584 ng/ml | Standard Deviation 0.137 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 24 (ng/ml) | 0.618 ng/ml | Standard Deviation 0.148 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 26 (ng/ml) | 0.592 ng/ml | Standard Deviation 0.123 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 28 (ng/ml) | 0.658 ng/ml | Standard Deviation 0.155 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 30 (ng/ml) | 0.680 ng/ml | Standard Deviation 0.099 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 32 (ng/ml) | 0.621 ng/ml | Standard Deviation 0.162 |
| Good Sleep Group | 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 | Amyloid-beta-42 concentration at hour 34 (ng/ml) | 0.620 ng/ml | Standard Deviation 0.146 |
p-value: 0.0595% CI: [-0.017, 0.256]Mixed Models Analysis
Primary
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)
Time frame: 36 hours of CSF collection
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 26 (ng/ml) | 0.674 ng/ml | Standard Deviation 0.198 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 12 (ng/ml) | 0.635 ng/ml | Standard Deviation 0.205 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 4 (ng/ml) | 0.583 ng/ml | Standard Deviation 0.18 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 24 (ng/ml) | 0.691 ng/ml | Standard Deviation 0.177 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 14 (ng/ml) | 0.645 ng/ml | Standard Deviation 0.203 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 36 (ng/ml) | 0.743 ng/ml | Standard Deviation 0.183 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 22 (ng/ml) | 0.674 ng/ml | Standard Deviation 0.203 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 16 (ng/ml) | 0.661 ng/ml | Standard Deviation 0.196 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 32 (ng/ml) | 0.652 ng/ml | Standard Deviation 0.194 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 20 (ng/ml) | 0.680 ng/ml | Standard Deviation 0.195 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 18 (ng/ml) | 0.659 ng/ml | Standard Deviation 0.184 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 6 (ng/ml) | 0.573 ng/ml | Standard Deviation 0.155 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 2 (ng/ml) | 0.600 ng/ml | Standard Deviation 0.232 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 28 (ng/ml) | 0.692 ng/ml | Standard Deviation 0.191 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 8 (ng/ml) | 0.598 ng/ml | Standard Deviation 0.189 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 0 (ng/ml) | 0.573 ng/ml | Standard Deviation 0.206 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 30 (ng/ml) | 0.660 ng/ml | Standard Deviation 0.183 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 10 (ng/ml) | 0.602 ng/ml | Standard Deviation 0.173 |
| Poor Sleep Group Control | 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 | Amyloid-beta-42 concentration at hour 34 (ng/ml) | 0.682 ng/ml | Standard Deviation 0.201 |
| 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 | Amyloid-beta-42 concentration at hour 26 (ng/ml) | 0.653 ng/ml | Standard Deviation 0.193 |
| 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 | Amyloid-beta-42 concentration at hour 30 (ng/ml) | 0.631 ng/ml | Standard Deviation 0.189 |
| 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 | Amyloid-beta-42 concentration at hour 0 (ng/ml) | 0.519 ng/ml | Standard Deviation 0.171 |
| 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 | Amyloid-beta-42 concentration at hour 2 (ng/ml) | 0.520 ng/ml | Standard Deviation 0.182 |
| 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 | Amyloid-beta-42 concentration at hour 4 (ng/ml) | 0.536 ng/ml | Standard Deviation 0.205 |
| 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 | Amyloid-beta-42 concentration at hour 6 (ng/ml) | 0.544 ng/ml | Standard Deviation 0.207 |
| 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 | Amyloid-beta-42 concentration at hour 8 (ng/ml) | 0.546 ng/ml | Standard Deviation 0.217 |
| 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 | Amyloid-beta-42 concentration at hour 10 (ng/ml) | 0.544 ng/ml | Standard Deviation 0.222 |
| 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 | Amyloid-beta-42 concentration at hour 12 (ng/ml) | 0.558 ng/ml | Standard Deviation 0.222 |
| 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 | Amyloid-beta-42 concentration at hour 14 (ng/ml) | 0.583 ng/ml | Standard Deviation 0.223 |
| 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 | Amyloid-beta-42 concentration at hour 16 (ng/ml) | 0.619 ng/ml | Standard Deviation 0.233 |
| 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 | Amyloid-beta-42 concentration at hour 18 (ng/ml) | 0.614 ng/ml | Standard Deviation 0.205 |
| 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 | Amyloid-beta-42 concentration at hour 20 (ng/ml) | 0.615 ng/ml | Standard Deviation 0.197 |
| 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 | Amyloid-beta-42 concentration at hour 22 (ng/ml) | 0.631 ng/ml | Standard Deviation 0.199 |
| 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 | Amyloid-beta-42 concentration at hour 24 (ng/ml) | 0.646 ng/ml | Standard Deviation 0.198 |
| 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 | Amyloid-beta-42 concentration at hour 28 (ng/ml) | 0.652 ng/ml | Standard Deviation 0.191 |
| 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 | Amyloid-beta-42 concentration at hour 32 (ng/ml) | 0.627 ng/ml | Standard Deviation 0.215 |
| 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 | Amyloid-beta-42 concentration at hour 34 (ng/ml) | 0.627 ng/ml | Standard Deviation 0.226 |
| 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 | Amyloid-beta-42 concentration at hour 36 (ng/ml) | 0.624 ng/ml | Standard Deviation 0.217 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 12 (ng/ml) | 0.660 ng/ml | Standard Deviation 0.121 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 36 (ng/ml) | 0.724 ng/ml | Standard Deviation 0.126 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 24 (ng/ml) | 0.738 ng/ml | Standard Deviation 0.158 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 10 (ng/ml) | 0.679 ng/ml | Standard Deviation 0.124 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 8 (ng/ml) | 0.670 ng/ml | Standard Deviation 0.122 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 26 (ng/ml) | 0.737 ng/ml | Standard Deviation 0.169 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 6 (ng/ml) | 0.678 ng/ml | Standard Deviation 0.139 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 34 (ng/ml) | 0.714 ng/ml | Standard Deviation 0.159 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 28 (ng/ml) | 0.759 ng/ml | Standard Deviation 0.166 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 30 (ng/ml) | 0.707 ng/ml | Standard Deviation 0.125 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 4 (ng/ml) | 0.679 ng/ml | Standard Deviation 0.129 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 0 (ng/ml) | 0.648 ng/ml | Standard Deviation 0.146 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 18 (ng/ml) | 0.697 ng/ml | Standard Deviation 0.14 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 16 (ng/ml) | 0.685 ng/ml | Standard Deviation 0.12 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 32 (ng/ml) | 0.726 ng/ml | Standard Deviation 0.16 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 20 (ng/ml) | 0.707 ng/ml | Standard Deviation 0.139 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 14 (ng/ml) | 0.679 ng/ml | Standard Deviation 0.111 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 2 (ng/ml) | 0.648 ng/ml | Standard Deviation 0.129 |
| Poor Sleep Group Treatment 2 | 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 | Amyloid-beta-42 concentration at hour 22 (ng/ml) | 0.776 ng/ml | Standard Deviation 0.161 |
p-value: 0.0595% CI: [-0.078, 0.087]Mixed Models Analysis
p-value: 0.0595% CI: [-0.051, 0.117]Mixed Models Analysis