Trial · NCT00814502

Zolpidem CR and Hospitalized Patients With Dementia

NCT00814502, Not applicable, Completed, Massachusetts General Hospital; results first posted 2017-05-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Zolpidem CR and Hospitalized Patients With Dementia. Trials, record NCT00814502. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00814502

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Zolpidem CR and Hospitalized Patients With Dementia
NCT number: NCT00814502
Status: Completed
Phases: Not applicable
Enrollment: 20 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Dementia, Alzheimer Disease, Dementia, Vascular, Sleep Disorders, Circadian Dysregulation
Interventions: Zolpidem CR, Placebo
First posted: 2008-12-25
Last updated: 2017-05-22
Results first posted: 2017-05-22
Limitations and caveats: Small sample size. We were unable to control for different treatments that our subjects received as inpatients.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Sleep Efficiency	Post-intervention, up to 3 weeks	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.
Primary	Sleep Minutes	post-intervention, up to 3 weeks	Total 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.
Secondary	Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms	post-intervention, up to 3 weeks	Rating 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

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Sleep Efficiency	Post-intervention, up to 3 weeks	percentage of sleep (see above)	LEAST_SQUARES_MEAN
PRIMARY	Sleep Minutes	post-intervention, up to 3 weeks	sleep minutes	LEAST_SQUARES_MEAN
SECONDARY	Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms	post-intervention, up to 3 weeks	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Sleep Efficiency	Zolpidem CR		75.93	Standard Error 3.24	percentage of sleep (see above)
Sleep Efficiency	Placebo		75.30	Standard Error 3.14	percentage of sleep (see above)
Sleep Minutes	Zolpidem CR		443.71	Standard Error 30.11	sleep minutes
Sleep Minutes	Placebo		422.49	Standard Error 29.27	sleep minutes
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms	Zolpidem CR	NPI Total Score	18.00	Standard Error 5.72	units on a scale
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms	Placebo	NPI Total Score	18.64	Standard Error 5.36	units on a scale
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms	Zolpidem CR	RAGE Total Score	1.40	Standard Error 1.31	units on a scale
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms	Placebo	RAGE Total Score	5.82	Standard Error 2.07	units on a scale
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms	Zolpidem CR	DBRS Total Score	22.64	Standard Error 0.56	units on a scale
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms	Placebo	DBRS Total Score	22.47	Standard Error 0.58	units on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Zolpidem CR	8
Overall Study	STARTED	Placebo	9
Overall Study	COMPLETED	Zolpidem CR	7
Overall Study	COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	Zolpidem CR	1
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dizziness	Nervous system disorders	Zolpidem CR	2	8
other	Dizziness	Nervous system disorders	Placebo	1	9
other	Confusion	Nervous system disorders	Zolpidem CR	0	8
other	Confusion	Nervous system disorders	Placebo	2	9
other	Feeling foggy or tired	Nervous system disorders	Zolpidem CR	1	8	1
other	Feeling foggy or tired	Nervous system disorders	Placebo	0	9	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zolpidem CR	0	8
Total, all-cause mortality	Placebo	0	9
Total, other adverse events	Zolpidem CR	3	8
Total, other adverse events	Placebo	2	9
Total, serious adverse events	Zolpidem CR	0	8
Total, serious adverse events	Placebo	0	9

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33189083	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Zolpidem CR vs Placebo: deaths from any cause	Trial comparisons
Zolpidem CR vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00814502

GET https://conductscience.org/api/trials/v1/NCT00814502/registered

API reference For AI assistants