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Zolpidem CR and Hospitalized Patients With Dementia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814502
First Posted: December 25, 2008
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Kaloyan Tanev, MD, Massachusetts General Hospital
December 18, 2008
December 25, 2008
February 2, 2017
May 22, 2017
May 22, 2017
December 2008
December 2013   (Final data collection date for primary outcome measure)
  • Sleep Efficiency [ Time Frame: 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.

  • Sleep Minutes [ Time Frame: 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.

Sleep efficiency and other actigraphy derived sleep parameters [ Time Frame: 48 hours pre-intervention; week 2-3 post intervention ]
Complete list of historical versions of study NCT00814502 on ClinicalTrials.gov Archive Site
Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms [ Time Frame: 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

Measures of aggression, psychosis, general clinical status, cognitive measures, mood symptoms, length of hospital stay, and percentage of patients who remain on Zolpidem CR at the end of the study. [ Time Frame: 48 hours pre-intervention; week 2-3 post-intervention ]
Not Provided
Not Provided
 
Zolpidem CR and Hospitalized Patients With Dementia
Does Zolpidem CR Treatment Change Clinical Outcomes in Elderly Hospitalized Patients With Dementia- A Pilot Study
The purpose of this research study is to compare the effectiveness of Zolpidem CR to that of placebo in improving sleep efficiency in people with dementia admitted to the hospital because of their symptoms. You can participate in this study if you have dementia of the Alzheimer's type or vascular dementia. This study involves placebo; a placebo is a tablet that looks exactly like Zolpidem CR, the study drug, but contains no active study drug. We will use placebos to see if the study results are due to the study drug or due to other reasons. Zolpidem CR is also called Ambien CR and is widely available by prescription. Zolpidem CR is approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of insomnia (trouble falling or staying asleep).
Sleep patterns normally change with age. Sleep/wake cycles appear to be compromised in people suffering from dementia. Most research involving sleep in dementia has involved community dwelling or nursing home residents. Relatively little is known about the sleep patterns of patients with dementia who develop acute behavioral and psychiatric symptoms and necessitate hospitalization. The relationship between sleep disturbances in these patients and behavioral/psychiatric symptoms is also insufficiently studied. The current study will examine these two sets of data (sleep/wake cycles and clinical symptoms) in a population of elderly subjects with Dementia of the Alzheimer's type (DAT) or vascular dementia (VD) during their hospitalization period. We will compare the sleep outcome measures (primarily sleep efficiency) and clinical outcome measures in subjects treated with Zolpidem CR or Placebo. We will utilize a double-blind, randomized, placebo-controlled design to test our hypothesis that targeting sleep disturbances in hospitalized elderly subjects with DAT or VD leads to improvement in sleep and clinical outcomes.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dementia
  • Alzheimer Disease
  • Dementia, Vascular
  • Sleep Disorders
  • Circadian Dysregulation
  • Drug: Zolpidem CR
    After a 48-hour period of baseline actigraphy and clinical measurements, study subjects were 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.
    Other Name: Ambien CR
  • Drug: Placebo
    After a 48-hour period of baseline actigraphy and clinical measurements, study subjects were 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.
  • Active Comparator: Zolpidem CR
    Subjects randomized to Zolpidem CR
    Intervention: Drug: Zolpidem CR
  • Placebo Comparator: Placebo
    Subjects randomized to Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 60-99 years
  • Clinical diagnosis of Dementia of the Alzheimer's type or Vascular Dementia
  • Only subjects with Mini Mental Status Examination scores of greater or equal to 10 will be enrolled.

Exclusion Criteria:

  1. Subjects who are too agitated to be able to wear the activity monitors;
  2. Subjects who are actively suicidal or homicidal or for whom the clinical treatment team considers participation in the study to be unsuitable;
  3. Subjects with untreated primary sleep disorders;
  4. Subjects who receive hypnotic medications during their participation in the study; Subjects who received hypnotic medications prior to enrollment may participate in the study if they agree to stop receiving hypnotic medications (with their attending physician's approval);
  5. Subjects who are receiving over the counter sleep aids;
  6. Subjects who can not commit to abstaining from alcohol use while in the study;
  7. Subjects with known anaphylactic reaction or angioedema with Zolpidem CR.
Sexes Eligible for Study: All
60 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00814502
2008-P-001434/1
Yes
Not Provided
Plan to Share IPD: No
Kaloyan Tanev, MD, Massachusetts General Hospital
Massachusetts General Hospital
Sanofi
Principal Investigator: Kaloyan S Tanev, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP