Zolpidem CR and Hospitalized Patients With Dementia
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dementia; Alzheimer Disease; Dementia, Vascular; Sleep Disorders; Circadian Dysregulation
Intervention: Zolpidem CR (Drug); Zolpidem CR placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Kaloyan S Tanev, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
Overall contact:
Kaloyan S Tanev, MD, Phone: 617-726-7511, Email: ktanev@partners.org
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).
Clinical Details
Official title: Does Zolpidem CR Treatment Change Clinical Outcomes in Elderly Hospitalized Patients With Dementia- A Pilot Study
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sleep efficiency and other actigraphy derived sleep parameters
Secondary outcome: 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.
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
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Kaloyan S Tanev, MD, Phone: 617-726-7511, Email: ktanev@partners.org
Massachusetts General Hospital, Boston, Massachusetts 02144, United States; Recruiting
Kaloyan S Tanev, MD, Phone: 617-726-7511, Email: ktanev@partners.org
Rita Seabrook, Phone: 617-624-9142, Email: rseabrook@partners.org
Kaloyan S Tanev, MD, Principal Investigator
Additional Information
Starting date: December 2008
Ending date: December 2010
Last updated: September 25, 2009
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