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Zolpidem CR and Hospitalized Patients With Dementia

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Kaloyan Tanev, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00814502
First received: December 18, 2008
Last updated: April 12, 2017
Last verified: April 2017
  Purpose
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).

Condition Intervention
Dementia Alzheimer Disease Dementia, Vascular Sleep Disorders Circadian Dysregulation Drug: Zolpidem CR Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Does Zolpidem CR Treatment Change Clinical Outcomes in Elderly Hospitalized Patients With Dementia- A Pilot Study

Resource links provided by NLM:


Further study details as provided by Kaloyan Tanev, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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



Enrollment: 20
Study Start Date: December 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zolpidem CR
Subjects randomized to Zolpidem CR
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
Placebo Comparator: Placebo
Subjects randomized to Placebo
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.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   60 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814502

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02144
Sponsors and Collaborators
Massachusetts General Hospital
Sanofi
Investigators
Principal Investigator: Kaloyan S Tanev, MD Massachusetts General Hospital
  More Information

Responsible Party: Kaloyan Tanev, MD, Neuropsychiatrist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00814502     History of Changes
Other Study ID Numbers: 2008-P-001434/1
Study First Received: December 18, 2008
Results First Received: February 2, 2017
Last Updated: April 12, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kaloyan Tanev, MD, Massachusetts General Hospital:
Alzheimer disease
Dementia, vascular
Actigraphy
Circadian dysregulation
Sleep Disorders
Circadian rhythm

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Sleep Wake Disorders
Parasomnias
Dementia, Vascular
Chronobiology Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents

ClinicalTrials.gov processed this record on July 21, 2017