Mirtazapine for Sleep Disorders in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

Mirtazapine for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01867775
• Other study ID #: 052/2012
• Status: Recruiting
• Phase: Phase 3
• First received: May 30, 2013
• Last updated: June 3, 2013
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2013
• Source: Brasilia University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether mirtazapine is effective in the treatment of sleep disorders in Alzheimers disease.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

Fifty-five years of age or older; Diagnosis of probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Disease and Related Disorders Association criteria; Hachinski Ischemia Scale score less than 5 Mini-Mental State Examination score of O to 26 Actigraph evidence of a mean time immobile of less than 7 hours per night based on at least 7 nights of complete actigraph data collected over a single week; For-week history of sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver using the Neuropsychiatric Inventory (NPI) Nighttime Behavior scale; Sleep disturbance observed was not present before the diagnosis of AD; Other co-morbidities, especially delirium, depression, chronic pain and medication use may be present, but do not cooperate in the primary symptoms; Computed tomography or magnetic resonance imaging since the onset of memory problems showing no more than 1 lacunar infarct in a nonstrategic area and no clinical events suggestive of stroke or other intracranial disease or normal; Stable medications for 4 weeks prior to the screening visit; Having a mobile upper extremity to which to attach an actigraph; Residing with a responsible spouse, family member, or professional caregiver who is present during the night and would agree to assume the role of the principal caregiver for the 3-week protocol; Ability to ingest oral medication and participate in all scheduled evaluations

Exclusion Criteria:

Sleep disturbance associated with an acute illness, delirium or psychiatric disease; Clinically significant movement disorder, such as akinesia, that would affect actigraphic differentiation of sleep and wakefulness Severe agitation; Unstable medical condition; Discontinuation of psychotropic or sleep medications within 2 weeks of the screening visit; Patient unwilling to maintain caffeine abstinence after 2:00 PM for the duration of the protocol; Patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, and only 1 alcoholic drink after 6:00 PM for the duration of the protocol; Prior use of mirtazapine for the treatment of sleep disturbances; Caregiver deemed too unreliable to supervise the wearing of the actigraph, to administer trazodone the proper time, to maintain tbe sleep diary, or to bring the patient to the scheduled visits;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Parasomnias
• Sleep Disorders

Intervention

Drug:
• Mirtazapine
Mirtazapine 15 mg, at night, once a day for 14 days

Locations

Country	Name	City	State
Brazil	Brasilia University	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Nighttime Total Sleep Time	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	Baseline, 14 days follow-up	No
Secondary	Change From Baseline in Nighttime Number Of Awakenings	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.	Baseline, 14 days follow-up	No
Secondary	Change From Baseline in Nighttime Wake After Sleep Onset	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.	Baseline, 14 days follow-up	No
Secondary	Change From Baseline in in Daytime Total Sleep Time		Baseline, 14 days follow-up	No
Secondary	Change From Baseline in Number of Daytime Naps		Baseline, 14 days follow-up]	No
Secondary	Change in Cognitive Function (as Measured by the Mini-Mental State Examination)		Baseline, 14 days follow-up]	No
Secondary	Change in Activities of Daily Living (The Index of ADL - Katz)		Baseline, 14 days follow-up]	No
Secondary	Change of Baseline in Behavioral Variables (BAHAVE-AD Scale)		Baseline, 14 days follow-up]	No
Secondary	Change From Baseline in Cognitive Function (Digit Symbol Substitution Test)		Baseline, 14 days follow-up]	No