Status:
COMPLETED
A Study to Evaluate Sleep Quality in Patients With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Janssen-Cilag, S.A.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60+ years
Brief Summary
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.
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 anticholines...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
925 Patients enrolled
Trial Details
Trial ID
NCT01478204
Start Date
June 1 2008
End Date
July 1 2009
Last Update
October 31 2012
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