A Study to Evaluate Sleep Quality in Patients With Mild to Moderate Alzheimer's Disease

NCT01478204 | Completed

• 2 other identifiers: CR017509GALALZ4037
• Study Type: observational
• Target: 925
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; Sleep quality; Anticholinesterase drugs

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The Level of Daytime Sleepiness determined by the Scores on the Epworth Sleepiness Scale

  Up to 3 months

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the neurology clinic of participating centers throughout Spain who meet eligibility criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

MeSH Terms

Conditions

Alzheimer Disease; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Janssen-Cilag S.A., Spain Clinical Trial

  Janssen-Cilag, S.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 23, 2011
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: October 31, 2012

Record last verified: 2012-10