Mirtazapine for Sleep Disorders in Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT01867775|
Recruitment Status : Unknown
Verified May 2013 by Einstein Francisco de Camargos, Brasilia University Hospital.
Recruitment status was: Recruiting
First Posted : June 4, 2013
Last Update Posted : June 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Sleep Disorders||Drug: Mirtazapine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Mirtazapine for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Double-blind, Placebo-controlled Study|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||May 2014|
U.S. FDA Resources
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
- 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] ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867775
|Brasilia, Distrito Federal, Brazil, 70840|
|Contact: Francisca M Scoralick email@example.com|
|Sub-Investigator: Francisca M Scoralick|
|Principal Investigator:||Francisca M Scoralick, MD||University of Brasilia|