Zolpidem CR and Hospitalized Patients With Dementia

Alzheimer Disease Clinical Trial

Official title:

Does Zolpidem CR Treatment Change Clinical Outcomes in Elderly Hospitalized Patients With Dementia- A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814502
• Other study ID #: 2008-P-001434/1
• Status: Completed
• Phase: N/A
• First received: December 18, 2008
• Last updated: December 19, 2013
• Start date: December 2008
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Chronobiology Disorders
• Circadian Dysregulation
• Dementia
• Dementia, Vascular
• Parasomnias
• Sleep Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency and other actigraphy derived sleep parameters		48 hours pre-intervention; week 2-3 post intervention	Yes
Secondary	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.		48 hours pre-intervention; week 2-3 post-intervention	Yes