Zolpidem CR and Hospitalized Patients With Dementia

NCT00814502 | Completed Results DMC

• 1 other identifier: 2008-P-001434/1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular; Sleep Disorders; Circadian Dysregulation

Keywords

Alzheimer disease; Dementia, vascular; Actigraphy; Circadian dysregulation; Sleep Disorders; Circadian rhythm

Outcome Measures

Primary Outcomes (2)

• Sleep Efficiency

  Sleep efficiency during the down interval. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. Sleep efficiency is calculated as (100\*sleep minutes)/\[time interval from sleep onset (as defined by the sleep latency) to sleep offset (the end of the last sleep episode in the Down interval)\]. The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data.

  Post-intervention, up to 3 weeks

• Sleep Minutes

  Total sleep minutes during the down period. The down interval signifies the period of time (in minutes) at night when subjects are in bed and trying to sleep. The time period was different for each patient, it was their duration of hospitalization. The first 48 hours patients were not on the study drug, so the reported least squares mean is an estimate of the mean for the subsequent time period where the patients received different therapies. These means are corrected for differences that might have existed during the first 48 hours. The results would be similar to the results attained from considering the mean during the first 48 hours as a baseline covariate in an Analysis of Covariance, but would be more robust to missing data.

  post-intervention, up to 3 weeks

Secondary Outcomes (1)

• Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms

  post-intervention, up to 3 weeks

Study Arms (2)

Zolpidem CR

ACTIVE COMPARATOR

Subjects randomized to Zolpidem CR

Drug: Zolpidem CR

Placebo

PLACEBO COMPARATOR

Subjects randomized to Placebo

Drug: Placebo

Interventions

Zolpidem CR DRUG

After a 48-hour period of baseline actigraphy and clinical measurements, study subjects were 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.

Also known as: Ambien CR

Zolpidem CR

Placebo DRUG

After a 48-hour period of baseline actigraphy and clinical measurements, study subjects were 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.

Placebo

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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);
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Sanofi: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02144, United States

Location

Related Publications (1)

• 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.

  PMID: 33189083 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular; Sleep Wake Disorders; Chronobiology Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Small sample size. We were unable to control for different treatments that our subjects received as inpatients.

Results Point of Contact

• Title: Kaloyan Tanev, M.D.
• Organization: Massachusetts General Hospital

ktanev@partners.org

617-726-7511

Study Officials

• Kaloyan S Tanev, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuropsychiatrist

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 25, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 22, 2017
• Results First Posted: May 22, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)