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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 November 2012 |
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Main ID: |
NCT01478204 |
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Date of registration:
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21/11/2011 |
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Primary sponsor: |
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Public title:
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A Study to Evaluate Sleep Quality in Patients With Mild to Moderate Alzheimer's Disease
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Scientific title:
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An Observational Epidemiological Study on Evaluation of Sleep Quality in Patients With Mild to Moderate Alzheimer's Disease in Clinical Practice |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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925 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01478204 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Contacts
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Name:
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Janssen-Cilag S.A., Spain Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen-Cilag, S.A. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
60 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Primary Outcome(s)
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Sleep disturbances measures by Scores on the Pittsburgh Sleep Quality Index (PSQI) Scale
[Time Frame: Up to 3 months]
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Secondary Outcome(s)
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The Level of Daytime Sleepiness determined by the Scores on the Epworth Sleepiness Scale
[Time Frame: Up to 3 months]
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Secondary ID(s)
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CR017509
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GALALZ4037
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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