Trial Outcomes & Findings for Zolpidem CR and Hospitalized Patients With Dementia (NCT NCT00814502)
NCT ID: NCT00814502
Last Updated: 2017-05-22
Results Overview
Sleep efficiency during the down interval. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. Sleep efficiency is calculated as (100\*sleep minutes)/\[time interval from sleep onset (as defined by the sleep latency) to sleep offset (the end of the last sleep episode in the Down interval)\]. The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data.
COMPLETED
NA
20 participants
Post-intervention, up to 3 weeks
2017-05-22
Participant Flow
Subjects were recruited from among the patients admitted to the Massachusetts General Psychiatric inpatient service, Blake 11. Inclusion criteria included age between 60-99 years and a clinical diagnosis of Alzheimer's dementia and/or vascular dementia using DSM-IV criteria.
3 subjects signed informed consent (IC) but were never randomized, and are not included in the table below. One changed his mind prior to randomization; another had untreated sleep apnea, discovered the day after he signed IC; the IC of a third subject was not received from her health care proxy until after her discharge from the hospital.
Participant milestones
| Measure |
Zolpidem CR
Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Zolpidem CR received Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
Placebo
Subjects randomized to Placebo
After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Placebo received Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Zolpidem CR
Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Zolpidem CR received Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
Placebo
Subjects randomized to Placebo
After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Placebo received Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Zolpidem CR and Hospitalized Patients With Dementia
Baseline characteristics by cohort
| Measure |
Zolpidem CR
n=8 Participants
Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
Placebo
n=9 Participants
Subjects randomized to Placebo
Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age > = 60
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Customized
Age < 60
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-intervention, up to 3 weeksSleep efficiency during the down interval. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. Sleep efficiency is calculated as (100\*sleep minutes)/\[time interval from sleep onset (as defined by the sleep latency) to sleep offset (the end of the last sleep episode in the Down interval)\]. The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data.
Outcome measures
| Measure |
Zolpidem CR
n=8 Participants
Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
Placebo
n=9 Participants
Subjects randomized to Placebo
After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
|---|---|---|
|
Sleep Efficiency
|
75.93 percentage of sleep (see above)
Standard Error 3.24
|
75.30 percentage of sleep (see above)
Standard Error 3.14
|
PRIMARY outcome
Timeframe: post-intervention, up to 3 weeksTotal sleep minutes during the down period. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data.
Outcome measures
| Measure |
Zolpidem CR
n=8 Participants
Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
Placebo
n=9 Participants
Subjects randomized to Placebo
After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
|---|---|---|
|
Sleep Minutes
|
443.71 sleep minutes
Standard Error 30.11
|
422.49 sleep minutes
Standard Error 29.27
|
SECONDARY outcome
Timeframe: post-intervention, up to 3 weeksRating Scale for Aggressive Behavior in the Elderly (RAGE, 0-61); higher is worse. Disruptive Behavior Rating Scales (DBRS, 0-105); higher is worse. Neuropsychiatric Inventory (NPI, 0-144) - measures 12 different domains of neuropsychiatric symptoms such as delusions, hallucinations, anxiety, depression, apathy, etc.; higher is worse. Montgomery-Asberg Depression Rating Scale (MADRS, 0-90); higher is worse. Mini-mental state examination (MMSE, 0-30); higher is better. The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the firs
Outcome measures
| Measure |
Zolpidem CR
n=8 Participants
Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
Placebo
n=9 Participants
Subjects randomized to Placebo
After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
|---|---|---|
|
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms
NPI Total Score
|
18.00 units on a scale
Standard Error 5.72
|
18.64 units on a scale
Standard Error 5.36
|
|
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms
RAGE Total Score
|
1.40 units on a scale
Standard Error 1.31
|
5.82 units on a scale
Standard Error 2.07
|
|
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms
DBRS Total Score
|
22.64 units on a scale
Standard Error 0.56
|
22.47 units on a scale
Standard Error 0.58
|
|
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms
MMSE Total Score
|
24.45 units on a scale
Standard Error 2.05
|
21.57 units on a scale
Standard Error 1.93
|
|
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms
MADRS Total Score
|
22.96 units on a scale
Standard Error 4.75
|
22.56 units on a scale
Standard Error 4.80
|
Adverse Events
Zolpidem CR
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zolpidem CR
n=8 participants at risk
Subjects randomized to Zolpidem CR
Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
Placebo
n=9 participants at risk
Subjects randomized to Placebo
Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Overall time frame of adverse events collection - 4 years, 2 months. Per subject time frame of adverse events collection - duration of study participation - variable length, up to 21 days.
Adverse events were collected by regular investigator assessment, and by medical inpatient chart review of subjects participating in the study.
|
11.1%
1/9 • Overall time frame of adverse events collection - 4 years, 2 months. Per subject time frame of adverse events collection - duration of study participation - variable length, up to 21 days.
Adverse events were collected by regular investigator assessment, and by medical inpatient chart review of subjects participating in the study.
|
|
Nervous system disorders
Confusion
|
0.00%
0/8 • Overall time frame of adverse events collection - 4 years, 2 months. Per subject time frame of adverse events collection - duration of study participation - variable length, up to 21 days.
Adverse events were collected by regular investigator assessment, and by medical inpatient chart review of subjects participating in the study.
|
22.2%
2/9 • Overall time frame of adverse events collection - 4 years, 2 months. Per subject time frame of adverse events collection - duration of study participation - variable length, up to 21 days.
Adverse events were collected by regular investigator assessment, and by medical inpatient chart review of subjects participating in the study.
|
|
Nervous system disorders
Feeling "foggy" or tired
|
12.5%
1/8 • Number of events 1 • Overall time frame of adverse events collection - 4 years, 2 months. Per subject time frame of adverse events collection - duration of study participation - variable length, up to 21 days.
Adverse events were collected by regular investigator assessment, and by medical inpatient chart review of subjects participating in the study.
|
0.00%
0/9 • Overall time frame of adverse events collection - 4 years, 2 months. Per subject time frame of adverse events collection - duration of study participation - variable length, up to 21 days.
Adverse events were collected by regular investigator assessment, and by medical inpatient chart review of subjects participating in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60