Zolpidem CR and Hospitalized Patients With Dementia

Phase

N/A

Condition

Dementia

Sleep Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00814502

2008-P-001434/1

Ages 60-99
All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age between 60-99 years
Clinical diagnosis of Dementia of the Alzheimer's type or Vascular Dementia
Only subjects with Mini Mental Status Examination scores of greater or equal to 10will be enrolled.

Exclusion

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 treatmentteam considers participation in the study to be unsuitable;
Subjects with untreated primary sleep disorders;
Subjects who receive hypnotic medications during their participation in the study;Subjects who received hypnotic medications prior to enrollment may participate in thestudy if they agree to stop receiving hypnotic medications (with their attendingphysician's approval);
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 known anaphylactic reaction or angioedema with Zolpidem CR.

Study Design

December 01, 2008

December 31, 2013

Study 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.

Connect with a study center

Massachusetts General Hospital
Boston, Massachusetts 02144
United States
Site Not Available

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