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Zolpidem CR and Hospitalized Patients With Dementia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814502
First Posted: December 25, 2008
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Kaloyan Tanev, MD, Massachusetts General Hospital
Results First Submitted: February 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Dementia
Alzheimer Disease
Dementia, Vascular
Sleep Disorders
Circadian Dysregulation
Interventions: Drug: Zolpidem CR
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from among the patients admitted to the Massachusetts General Psychiatric inpatient service, Blake 11. Inclusion criteria included age between 60-99 years and a clinical diagnosis of Alzheimer's dementia and/or vascular dementia using DSM-IV criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 subjects signed informed consent (IC) but were never randomized, and are not included in the table below. One changed his mind prior to randomization; another had untreated sleep apnea, discovered the day after he signed IC; the IC of a third subject was not received from her health care proxy until after her discharge from the hospital.

Reporting Groups
  Description
Zolpidem CR

Subjects randomized to Zolpidem CR

Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Zolpidem CR received Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.

Placebo

Subjects randomized to Placebo

After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Placebo received Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay.


Participant Flow:   Overall Study
    Zolpidem CR   Placebo
STARTED   8   9 
COMPLETED   7   7 
NOT COMPLETED   1   2 
Adverse Event                1                0 
Withdrawal by Subject                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zolpidem CR

Subjects randomized to Zolpidem CR

Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be 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

Subjects randomized to Placebo

Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be 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.

Total Total of all reporting groups

Baseline Measures
   Zolpidem CR   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   9   17 
Age, Customized 
[Units: Participants]
Count of Participants
     
Age > = 60   8   9   17 
Age < 60   0   0   0 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      3  37.5%      4  44.4%      7  41.2% 
Male      5  62.5%      5  55.6%      10  58.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      4  50.0%      5  55.6%      9  52.9% 
Unknown or Not Reported      4  50.0%      4  44.4%      8  47.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1  11.1%      1   5.9% 
White      7  87.5%      8  88.9%      15  88.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1  12.5%      0   0.0%      1   5.9% 
Region of Enrollment 
[Units: Participants]
     
United States   8   9   17 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sleep Efficiency   [ Time Frame: Post-intervention, up to 3 weeks ]

2.  Primary:   Sleep Minutes   [ Time Frame: post-intervention, up to 3 weeks ]

3.  Secondary:   Measures of Aggression, Psychosis, General Clinical Status, Cognitive Measures, Mood Symptoms   [ Time Frame: post-intervention, up to 3 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size. We were unable to control for different treatments that our subjects received as inpatients.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kaloyan Tanev, M.D.
Organization: Massachusetts General Hospital
phone: 617-726-7511
e-mail: ktanev@partners.org



Responsible Party: Kaloyan Tanev, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00814502     History of Changes
Other Study ID Numbers: 2008-P-001434/1
First Submitted: December 18, 2008
First Posted: December 25, 2008
Results First Submitted: February 2, 2017
Results First Posted: May 22, 2017
Last Update Posted: May 22, 2017