View Clinical Trial (Medical Research Study)
Does Zolpidem CR Treatment Change Clinical Outcomes in Elderly Hospitalized Patients With Dementia- A Pilot Study
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02144 |
| Conditions: |
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Dementia - Alzheimer Disease - Dementia, Vascular - Sleep Disorders - Circadian Dysregulation |
| Purpose: |
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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).
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00814502 |
| Primary Contact: |
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Principal Investigator
Kaloyan S Tanev, MD
Massachusetts General Hospital
Kaloyan S Tanev, MD
Phone: 617-726-7511
Email: ktanev@partners.org
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| Backup Contact: |
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Email: cdubois2@partners.org
Christina Dubois
Phone: 617-724-9142
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| Location Contact: |
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Boston, Massachusetts 02144
United States
Kaloyan S Tanev, MD
Phone: 617-726-7511
Email: ktanev@partners.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
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