Zolpidem CR and Hospitalized Patients With Dementia
Condition: Dementia; Alzheimer Disease; Dementia, Vascular; Sleep Disorders; Circadian Dysregulation
MeSH terms: Alzheimer Disease; Dementia; Sleep Wake Disorders; Parasomnias; Dementia, Vascular; Chronobiology Disorders
Study type: Interventional

Summary: 
      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).
    

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.
    

Intervention name(s): Zolpidem CR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 intervention name(s): Ambien CR
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer disease; Dementia, vascular; Actigraphy; Circadian dysregulation; Sleep Disorders; Circadian rhythm