An Observational Epidemiological Study on Evaluation of Sleep Quality in Patients With Mild to Moderate Alzheimer's Disease in Clinical Practice
Sponsor study identifier
Secondary identifiers
OTHER · Janssen-Cilag S.A., Spain
observational
925
0 countries
N/A
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2009
Actual (reported)Study Completion
July 2009
Actual (reported)The purpose of this study is to evaluate sleep quality in patients with mild to moderate Alzheimer's disease treated with anticholinesterase drugs in clinical practice.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
June 2009
Actual (reported)July 2009
Actual (reported)November 21, 2011
Actual (reported)November 23, 2011
Actual (reported)Sleep disturbances measures by Scores on the Pittsburgh Sleep Quality Index (PSQI) Scale
The PSQI consists of 19 self-rated questions which assesses sleep quality and disturbances over 1-month time interval. The 19 questions assess a wide variety of factors relating to sleep quality, including estimates of sleep duration and the frequency and severity of specific sleep-related problems. These 19 items are grouped into seven components scores, each weighted equally on a 0-3 scale. The seven components scores are then summed to yield a global PSQI score, which has a range of 0-21; higher scores indicate worse sleep quality.
Up to 3 months
The Level of Daytime Sleepiness determined by the Scores on the Epworth Sleepiness Scale
Up to 3 months
Patients attending the neurology clinic of participating centers throughout Spain who meet eligibility criteria.
Janssen-Cilag S.A., Spain Clinical Trial
Janssen-Cilag, S.A.
925 participants (actual enrollment reported by the registry).
First Submitted
November 21, 2011
First Posted
November 23, 2011
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2009
Actual (reported)Study Completion
July 2009
Actual (reported)Last Updated
October 31, 2012
Record last verified: 2012-10
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Source: ClinicalTrials.gov.
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