Official Title: “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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2010

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(s) in this Clinical Trial

• Drug: 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.
• Drug: 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Zolpidem CR
  • Subjects randomized to Zolpidem CR
• Placebo Comparator: Placebo
  • Subjects randomized to Placebo

Primary Measures

• Sleep efficiency and other actigraphy derived sleep parameters
  • Time Frame: 48 hours pre-intervention; week 2-3 post intervention
    Safety Issue?: Yes

Secondary Measures

• 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
    Safety Issue?: Yes

Inclusion Criteria:

• Age between 60-99 years
• Clinical diagnosis of Dementia of the Alzheimer's type or Vascular Dementia

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 any hypnotic medications during their participation in the study; Subjects who received hypnotic medications in normal doses prior to Partners

Human Subjects Research Application Form Filename: Protocol Summary Version Date:

• June 1, 2005 5 enrollment may participate in the study if they agree to stop receiving hypnotic medications (see above).
• 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 any liver disease.
• 8. Subjects with known anaphylactic reaction or angioedema with Zolpidem CR.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Massachusetts General Hospital

Overall Clinical Trial Officials and Contacts

Kaloyan S Tanev, MD Principal Investigator Massachusetts General Hospital  

Overall Contact: Kaloyan S Tanev, MD 617-726-7511 ktanev@partners.org

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00814502

Study ID Number: 2008-P-001434/1

ClinicalTrials.gov Identifier: NCT00814502

Health Authority: United States: Institutional Review Board