Mirtazapine for Sleep Disorders in Alzheimer's Disease

June 3, 2013 updated by: Einstein Francisco de Camargos, Brasilia University Hospital

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

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

Study Overview

Status

Unknown

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Remeron
Placebo Comparator: Placebo
Placebo 15 mg, once a day at night for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 14 days follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 14 days follow-up
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.
Baseline, 14 days follow-up
Change From Baseline in in Daytime Total Sleep Time
Time Frame: Baseline, 14 days follow-up
Baseline, 14 days follow-up
Change From Baseline in Number of Daytime Naps
Time Frame: Baseline, 14 days follow-up]
Baseline, 14 days follow-up]
Change in Cognitive Function (as Measured by the Mini-Mental State Examination)
Time Frame: Baseline, 14 days follow-up]
Baseline, 14 days follow-up]
Change in Activities of Daily Living (The Index of ADL - Katz)
Time Frame: Baseline, 14 days follow-up]
Baseline, 14 days follow-up]
Change of Baseline in Behavioral Variables (BAHAVE-AD Scale)
Time Frame: Baseline, 14 days follow-up]
Baseline, 14 days follow-up]
Change From Baseline in Cognitive Function (Digit Symbol Substitution Test)
Time Frame: Baseline, 14 days follow-up]
Baseline, 14 days follow-up]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Francisca M Scoralick, MD, University of Brasilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 4, 2013

Study Record Updates

Last Update Posted (Estimate)

June 4, 2013

Last Update Submitted That Met QC Criteria

June 3, 2013

Last Verified

May 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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