- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01478204
A Study to Evaluate Sleep Quality in Patients With Mild to Moderate Alzheimer's Disease
October 30, 2012 updated by: Janssen-Cilag, S.A.
An Observational Epidemiological Study on Evaluation of Sleep Quality in Patients With Mild to Moderate Alzheimer's Disease in Clinical Practice
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.
Study Overview
Status
Completed
Conditions
Detailed Description
This is an epidemiological (the study of health-related states or events in specific populations) study of patients with mild to moderate Alzheimer's who have been treated previously with anticholinesterase drugs (class of drugs that act in the central nervous system) up to a maximum of fifteen days.
The data for each patient will be recorded on two occasions; first at a baseline visit and then at a follow-up visit at 3 months.
At the baseline visit, after the patient or his/her legal representative has given written informed consent, each participating neurologist will use the study questionnaire to collect patient sociodemographic characteristics (characteristics such as age, years of education, race, sex, religion, birthplace, income, occupation, geographic location, among others), medical history and diagnosis of Alzheimer's disease.
The neurologist will also record treatment for Alzheimer's disease and concomitant hypnotic medications (simultaneous use of medications that induce sleep) and evaluate the patient using two scales: the Pittsburgh Sleep Quality Index (PSQI) to record sleep disturbances and the Epworth Sleepiness Scale to determine the level of daytime sleepiness.
Alzheimer treatment and concomitant hypnotic medications will be recorded again at the follow-up visit.
Patient sleep quality using the PSQI and daytime sleepiness using the Epworth scale will also be evaluated again at this visit.
Study Type
Observational
Enrollment (Actual)
925
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients attending the neurology clinic of participating centers throughout Spain who meet eligibility criteria.
Description
Inclusion Criteria:
- Patients with a recent diagnosis of possible or probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA criteria) within a maximum of 60 days before the baseline visit.
- Patients with mild or moderate Alzheimer's disease, defined by a Mini-Mental State Exam (MMSE) score between 11 and 25.
- Patients whose caregivers are sufficiently informed of the patients' state and if possible live with the patient.
- Patients who are capable of attending a second clinic visit with their accompanying person 3 months later, based on the clinical practice of the investigator.
- Patients and/or legal representatives who have given and signed written informed consent.
Exclusion Criteria:
- Patients who have psychotic manifestations.
- Patients who have clinically significant sleep disorder (sleep apnea syndrome, restless leg syndrome).
- Patients treated with memantine.
- Patients and/or legal representatives who refuse to give written informed consent to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep disturbances measures by Scores on the Pittsburgh Sleep Quality Index (PSQI) Scale
Time Frame: Up to 3 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Level of Daytime Sleepiness determined by the Scores on the Epworth Sleepiness Scale
Time Frame: Up to 3 months
|
The Epworth Sleepiness Scale measures how likely, from 0 (would never take a nap) to 3 (high change of dozing), the patient is to doze off or fall asleep in common everyday situations.
The scores for a total of eight questions are added together to obtain a single number.
A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought.
|
Up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Janssen-Cilag S.A., Spain Clinical Trial, Janssen-Cilag, S.A.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
November 21, 2011
First Submitted That Met QC Criteria
November 21, 2011
First Posted (Estimate)
November 23, 2011
Study Record Updates
Last Update Posted (Estimate)
October 31, 2012
Last Update Submitted That Met QC Criteria
October 30, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR017509
- GALALZ4037 (Other Identifier: Janssen-Cilag S.A., Spain)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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