Clinical trial NCT00814502: Zolpidem CR and Hospitalized Patients With Dementia
Official title: Does Zolpidem CR Treatment Change Clinical Outcomes in Elderly Hospitalized Patients With Dementia- A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Dementia, Vascular
Sleep Disorders
Circadian Dysregulation
Keywords: Alzheimer disease
Dementia, vascular
Actigraphy
Circadian dysregulation
Sleep Disorders
Circadian rhythm
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2008-12-25
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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 criteria: 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 10 will be enrolled.

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 hypnotic medications during their participation in the study; Subjects who received hypnotic medications prior to enrollment may participate in the study if they agree to stop receiving hypnotic medications (with their attending physician's approval);
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 known anaphylactic reaction or angioedema with Zolpidem CR.

Primary outcomes:
measure: Sleep Efficiency
timeFrame: Post-intervention, up to 3 weeks
measure: Sleep Minutes
timeFrame: post-intervention, up to 3 weeks
Secondary outcomes:
measure: Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms
timeFrame: post-intervention, up to 3 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kaloyan S Tanev, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.