Trial Outcomes & Findings for Sleep Quality and Amyloid-Beta Kinetics (NCT NCT03077620)
NCT ID: NCT03077620
Last Updated: 2022-05-17
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
36 hours of CSF collection
Results posted on
2022-05-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
6
|
|
Overall Study
COMPLETED
|
13
|
13
|
12
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Unable to place lumbar catheter
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Sleep Quality and Amyloid-Beta Kinetics
Baseline characteristics by cohort
| Measure |
Poor Sleep Group Control
n=13 Participants
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.
|
Poor Sleep Group Treatment 1
n=13 Participants
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.
|
Poor Sleep Group Treatment 2
n=12 Participants
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.
|
Good Sleep Group
n=5 Participants
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.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
55.94 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
56.95 years
STANDARD_DEVIATION 4.35 • n=7 Participants
|
54.30 years
STANDARD_DEVIATION 5.66 • n=5 Participants
|
59.18 years
STANDARD_DEVIATION 7.24 • n=4 Participants
|
56.23 years
STANDARD_DEVIATION 5.69 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 36 hours of CSF collectionMean 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)
Outcome measures
| Measure |
Poor Sleep Group Control
n=13 Participants
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.
|
Good Sleep Group
n=5 Participants
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.
|
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.
|
|---|---|---|---|
|
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
|
0.542 ng/ml
Standard Deviation 0.174
|
—
|
|
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
|
0.578 ng/ml
Standard Deviation 0.139
|
—
|
|
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
|
0.658 ng/ml
Standard Deviation 0.155
|
—
|
|
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
|
0.623 ng/ml
Standard Deviation 0.189
|
—
|
|
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
|
0.520 ng/ml
Standard Deviation 0.168
|
—
|
|
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 0.180
|
0.528 ng/ml
Standard Deviation 0.171
|
—
|
|
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
|
0.548 ng/ml
Standard Deviation 0.155
|
—
|
|
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
|
0.537 ng/ml
Standard Deviation 0.149
|
—
|
|
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
|
0.536 ng/ml
Standard Deviation 0.129
|
—
|
|
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
|
0.556 ng/ml
Standard Deviation 0.126
|
—
|
|
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
|
0.579 ng/ml
Standard Deviation 0.131
|
—
|
|
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
|
0.568 ng/ml
Standard Deviation 0.123
|
—
|
|
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
|
0.584 ng/ml
Standard Deviation 0.137
|
—
|
|
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
|
0.618 ng/ml
Standard Deviation 0.148
|
—
|
|
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
|
0.592 ng/ml
Standard Deviation 0.123
|
—
|
|
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
|
0.680 ng/ml
Standard Deviation 0.099
|
—
|
|
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
|
0.621 ng/ml
Standard Deviation 0.162
|
—
|
|
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
|
0.620 ng/ml
Standard Deviation 0.146
|
—
|
|
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
|
0.625 ng/ml
Standard Deviation 0.143
|
—
|
PRIMARY outcome
Timeframe: 36 hours of CSF collectionMean 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)
Outcome measures
| Measure |
Poor Sleep Group Control
n=13 Participants
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.
|
Good Sleep Group
n=13 Participants
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.
|
Poor Sleep Group Treatment 2
n=12 Participants
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.
|
|---|---|---|---|
|
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
|
0.520 ng/ml
Standard Deviation 0.182
|
0.648 ng/ml
Standard Deviation 0.129
|
|
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
|
0.619 ng/ml
Standard Deviation 0.233
|
0.685 ng/ml
Standard Deviation 0.120
|
|
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
|
0.653 ng/ml
Standard Deviation 0.193
|
0.737 ng/ml
Standard Deviation 0.169
|
|
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
|
0.519 ng/ml
Standard Deviation 0.171
|
0.648 ng/ml
Standard Deviation 0.146
|
|
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 0.180
|
0.536 ng/ml
Standard Deviation 0.205
|
0.679 ng/ml
Standard Deviation 0.129
|
|
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
|
0.544 ng/ml
Standard Deviation 0.207
|
0.678 ng/ml
Standard Deviation 0.139
|
|
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
|
0.546 ng/ml
Standard Deviation 0.217
|
0.670 ng/ml
Standard Deviation 0.122
|
|
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
|
0.544 ng/ml
Standard Deviation 0.222
|
0.679 ng/ml
Standard Deviation 0.124
|
|
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
|
0.558 ng/ml
Standard Deviation 0.222
|
0.660 ng/ml
Standard Deviation 0.121
|
|
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
|
0.583 ng/ml
Standard Deviation 0.223
|
0.679 ng/ml
Standard Deviation 0.111
|
|
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
|
0.614 ng/ml
Standard Deviation 0.205
|
0.697 ng/ml
Standard Deviation 0.140
|
|
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
|
0.615 ng/ml
Standard Deviation 0.197
|
0.707 ng/ml
Standard Deviation 0.139
|
|
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
|
0.631 ng/ml
Standard Deviation 0.199
|
0.776 ng/ml
Standard Deviation 0.161
|
|
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
|
0.646 ng/ml
Standard Deviation 0.198
|
0.738 ng/ml
Standard Deviation 0.158
|
|
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
|
0.652 ng/ml
Standard Deviation 0.191
|
0.759 ng/ml
Standard Deviation 0.166
|
|
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
|
0.631 ng/ml
Standard Deviation 0.189
|
0.707 ng/ml
Standard Deviation 0.125
|
|
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
|
0.627 ng/ml
Standard Deviation 0.215
|
0.726 ng/ml
Standard Deviation 0.16
|
|
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
|
0.627 ng/ml
Standard Deviation 0.226
|
0.714 ng/ml
Standard Deviation 0.159
|
|
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
|
0.624 ng/ml
Standard Deviation 0.217
|
0.724 ng/ml
Standard Deviation 0.126
|
Adverse Events
Poor Sleep Group Control
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Poor Sleep Group Treatment 1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Poor Sleep Group Treatment 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Good Sleep Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Poor Sleep Group Control
n=13 participants at risk
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.
|
Poor Sleep Group Treatment 1
n=13 participants at risk
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.
|
Poor Sleep Group Treatment 2
n=12 participants at risk
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.
|
Good Sleep Group
n=6 participants at risk
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.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
76.9%
10/13 • Number of events 10 • 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).
|
53.8%
7/13 • Number of events 7 • 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).
|
75.0%
9/12 • Number of events 9 • 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).
|
33.3%
2/6 • Number of events 2 • 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).
|
|
Nervous system disorders
Headache requiring blood patch
|
15.4%
2/13 • Number of events 2 • 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).
|
38.5%
5/13 • Number of events 5 • 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).
|
16.7%
2/12 • Number of events 2 • 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).
|
0.00%
0/6 • 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).
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Number of events 3 • 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).
|
30.8%
4/13 • Number of events 4 • 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).
|
16.7%
2/12 • Number of events 2 • 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).
|
16.7%
1/6 • Number of events 1 • 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).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • 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).
|
23.1%
3/13 • Number of events 3 • 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).
|
16.7%
2/12 • Number of events 2 • 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).
|
0.00%
0/6 • 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).
|
|
Cardiac disorders
Presyncope with lumbar catheter placement
|
15.4%
2/13 • Number of events 2 • 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).
|
7.7%
1/13 • Number of events 1 • 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).
|
0.00%
0/12 • 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).
|
0.00%
0/6 • 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).
|
|
Musculoskeletal and connective tissue disorders
Back/neck pain
|
30.8%
4/13 • Number of events 4 • 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).
|
46.2%
6/13 • Number of events 6 • 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).
|
58.3%
7/12 • Number of events 7 • 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).
|
33.3%
2/6 • Number of events 2 • 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).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/13 • 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).
|
7.7%
1/13 • Number of events 1 • 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).
|
0.00%
0/12 • 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).
|
0.00%
0/6 • 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).
|
|
Skin and subcutaneous tissue disorders
Rash, swelling, or bruising at lumbar catheter site
|
15.4%
2/13 • Number of events 2 • 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).
|
0.00%
0/13 • 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).
|
8.3%
1/12 • Number of events 1 • 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).
|
33.3%
2/6 • Number of events 2 • 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).
|
|
Ear and labyrinth disorders
Ringing in ears
|
0.00%
0/13 • 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).
|
7.7%
1/13 • Number of events 1 • 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).
|
16.7%
2/12 • Number of events 2 • 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).
|
0.00%
0/6 • 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).
|
Additional Information
Dr. Brendan Lucey
Washington University in St Louis School of Medicine
Phone: 314-747-3805
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place