- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01867775
Mirtazapine for Sleep Disorders in Alzheimer's Disease
Mirtazapine for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Double-blind, Placebo-controlled Study
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Distrito Federal
-
Brasilia, Distrito Federal, Brazil, 70840
- Recruiting
- Brasilia University
-
Contact:
- Francisca M Scoralick
- Email: franciscascoralick@gmail.com
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Sub-Investigator:
- Francisca M Scoralick
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Sponsor
Investigators
- Principal Investigator: Francisca M Scoralick, MD, University of Brasilia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Disease
- Sleep Wake Disorders
- Parasomnias
- Alzheimer Disease
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Anti-Anxiety Agents
- Serotonin 5-HT3 Receptor Antagonists
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Mirtazapine
Other Study ID Numbers
- 052/2012
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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