Mirtazapine for Sleep Disorders in Alzheimer's Disease
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Mirtazapine for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Double-blind, Placebo-controlled Study|
- Change From Baseline in Nighttime Total Sleep Time [ Time Frame: Baseline, 14 days follow-up ]Mean of Nighttime Total Sleep Time (in minutes) during the 12-h nocturnal epoch 8:00 PM - 08:00 AM after 2 weeks under treatment
- Change From Baseline in Nighttime Number Of Awakenings [ Time Frame: Baseline, 14 days follow-up ]Change in scores from baseline to intervention week was analyzed using an analysis of covariance (ANCOVA) with the change score as the dependent variable and the treatment condition and baseline score as independent variables.
- Change From Baseline in Nighttime Wake After Sleep Onset [ Time Frame: Baseline, 14 days follow-up ]Nighttime Wake After Sleep Onset (in minutes) after sleep onset until the final awakening during the 12-h nocturnal epoch 8:00 PM - 08:00 AM. After 2 weeks under treatment.
- Change From Baseline in in Daytime Total Sleep Time [ Time Frame: Baseline, 14 days follow-up ]
- Change From Baseline in Number of Daytime Naps [ Time Frame: Baseline, 14 days follow-up] ]
- Change in Cognitive Function (as Measured by the Mini-Mental State Examination) [ Time Frame: Baseline, 14 days follow-up] ]
- Change in Activities of Daily Living (The Index of ADL - Katz) [ Time Frame: Baseline, 14 days follow-up] ]
- Change of Baseline in Behavioral Variables (BAHAVE-AD Scale) [ Time Frame: Baseline, 14 days follow-up] ]
- Change From Baseline in Cognitive Function (Digit Symbol Substitution Test) [ Time Frame: Baseline, 14 days follow-up] ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Mirtazapine
Mirtazapine, 15 mg once a day, at night for 14 days
Mirtazapine 15 mg, at night, once a day for 14 days
Other Name: Remeron
Placebo Comparator: Placebo
Placebo 15 mg, once a day at night for 14 days
Mirtazapine has been used for depressed elderly with sleep disorders with good tolerability and efficacy. The study hypothesis is that mirtazapine could also be used in demented with sleep disorders.
Sleep disorders (SD) affects 35 to 50 percent of patients with Alzheimer Disease (AD). These disorders often make caring for patients at home very difficult and It's also associated with higher risk of institutionalization and increases health care costs. Treatment of SD in people with dementia may benefit both patients and their caregivers. However, little is known about the efficacy of pharmacological treatments for treating sleep disturbances in AD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01867775
|Brasilia, Distrito Federal, Brazil, 70840|
|Contact: Francisca M Scoralick firstname.lastname@example.org|
|Sub-Investigator: Francisca M Scoralick|
|Principal Investigator:||Francisca M Scoralick, MD||University of Brasilia|