Mirtazapine for Sleep Disorders in Alzheimer's Disease
Information source: Brasilia University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease; Sleep Disorders
Intervention: Mirtazapine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Brasilia University Hospital Official(s) and/or principal investigator(s): Francisca M Scoralick, MD, Principal Investigator, Affiliation: University of Brasilia
Summary
The purpose of this study is to determine whether mirtazapine is effective in the treatment
of sleep disorders in Alzheimers disease.
Clinical Details
Official title: Mirtazapine for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Double-blind, Placebo-controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Nighttime Total Sleep Time
Secondary outcome: Change From Baseline in Nighttime Number Of AwakeningsChange From Baseline in Nighttime Wake After Sleep Onset Change From Baseline in in Daytime Total Sleep Time Change From Baseline in Number of Daytime Naps Change in Cognitive Function (as Measured by the Mini-Mental State Examination) Change in Activities of Daily Living (The Index of ADL - Katz) Change of Baseline in Behavioral Variables (BAHAVE-AD Scale) Change From Baseline in Cognitive Function (Digit Symbol Substitution Test)
Detailed 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.
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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;
Locations and Contacts
Brasilia University, Brasilia, Distrito Federal 70840, Brazil; Recruiting Francisca M Scoralick, Email: franciscascoralick@gmail.com Francisca M Scoralick, Sub-Investigator
Additional Information
Starting date: May 2012
Last updated: June 3, 2013
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