Zolpidem CR and Hospitalized Patients With Dementia
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Purpose
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).
| Condition | Intervention |
|---|---|
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Dementia Alzheimer Disease Dementia, Vascular Sleep Disorders Circadian Dysregulation |
Drug: Zolpidem CR Drug: Zolpidem CR placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Does Zolpidem CR Treatment Change Clinical Outcomes in Elderly Hospitalized Patients With Dementia- A Pilot Study |
- Sleep efficiency and other actigraphy derived sleep parameters [ Time Frame: 48 hours pre-intervention; week 2-3 post intervention ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 24 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Zolpidem CR
Subjects randomized to Zolpidem CR
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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.
Other Name: Ambien CR
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|
Placebo Comparator: Placebo
Subjects randomized to Placebo
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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.
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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| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age between 60-99 years
- Clinical diagnosis of Dementia of the Alzheimer's type or Vascular Dementia
Exclusion Criteria:
- Subjects who are too agitated to be able to wear the activity monitors;
- Subjects who are actively suicidal or homicidal or for whom the clinical treatment team considers participation in the study to be unsuitable;
- Subjects with untreated primary sleep disorders
- 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).
- Subjects who are receiving over the counter sleep aids.
- Subjects who can not commit to abstaining from alcohol use while in the study.
- Subjects with any liver disease.
- Subjects with known anaphylactic reaction or angioedema with Zolpidem CR.
Contacts and Locations| Contact: Kaloyan S Tanev, MD | 617-726-7511 | ktanev@partners.org |
| Contact: Christina Dubois | 617-724-9142 | cdubois2@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02144 | |
| Contact: Kaloyan S Tanev, MD 617-726-7511 ktanev@partners.org | |
| Contact: Christina Dubois 617-624-9142 cdubois2@partners.org | |
| Principal Investigator: Kaloyan S Tanev, MD | |
| Principal Investigator: | Kaloyan S Tanev, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Kaloyan Tanev, MD, Neuropsychiatrist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00814502 History of Changes |
| Other Study ID Numbers: | 2008-P-001434/1 |
| Study First Received: | December 18, 2008 |
| Last Updated: | November 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Alzheimer disease Dementia, vascular Actigraphy |
Circadian dysregulation Sleep Disorders Circadian rhythm |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Dementia, Vascular Sleep Disorders Parasomnias Chronobiology Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Cerebrovascular Disorders Intracranial Arteriosclerosis |
Intracranial Arterial Diseases Leukoencephalopathies Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Neurologic Manifestations Signs and Symptoms Zolpidem Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013