Zolpidem CR and Hospitalized Patients With Dementia - Full Text View

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00814502

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
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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Sleep Disorders

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Sleep efficiency and other actigraphy derived sleep parameters [ Time Frame: 48 hours pre-intervention; week 2-3 post intervention ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Zolpidem CR Subjects randomized to Zolpidem CR	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
Placebo Comparator: Placebo Subjects randomized to Placebo	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.

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814502

Contacts

Contact: Kaloyan S Tanev, MD	617-726-7511	ktanev@partners.org
Contact: Rita Seabrook	617-724-9142	rseabrook@partners.org

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Kaloyan S Tanev, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Kaloyan Tanev, M.D., Massachusetts General Hospital, the General Hospital Corporation
ClinicalTrials.gov Identifier:	NCT00814502 History of Changes
Other Study ID Numbers:	2008-P-001434/1
Study First Received:	December 18, 2008
Last Updated:	July 22, 2011
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 February 09, 2012