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Zolpidem CR and Hospitalized Patients With Dementia

NCT00814502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-05-22

Study results available
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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

Interventions

DRUG

Zolpidem CR

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Kaloyan S Tanev, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00814502 on ClinicalTrials.gov