Status:
COMPLETED
Zolpidem CR and Hospitalized Patients With Dementia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Sanofi
Conditions:
Dementia
Alzheimer Disease
Eligibility:
All Genders
60-99 years
Phase:
NA
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 sym...
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 nurs...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00814502
Start Date
December 1 2008
End Date
December 1 2013
Last Update
May 22 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02144