Mirtazapine for Sleep Disorders in Alzheimer's Disease

• ClinicalTrials.gov Identifier: NCT01867775
• Recruitment Status: Unknown
• First Posted: June 4, 2013
• Last Update Posted: June 4, 2013
• Sponsor: Brasilia University Hospital
• Information provided by (Responsible Party): Einstein Francisco de Camargos, Brasilia University Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease; Sleep Disorders	Drug: Mirtazapine	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Mirtazapine; Mirtazapine, 15 mg once a day, at night for 14 days	Drug: Mirtazapine; 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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.
3. Change From Baseline in in Daytime Total Sleep Time [ Time Frame: Baseline, 14 days follow-up ]
4. Change From Baseline in Number of Daytime Naps [ Time Frame: Baseline, 14 days follow-up] ]
5. Change in Cognitive Function (as Measured by the Mini-Mental State Examination) [ Time Frame: Baseline, 14 days follow-up] ]
6. Change in Activities of Daily Living (The Index of ADL - Katz) [ Time Frame: Baseline, 14 days follow-up] ]
7. Change of Baseline in Behavioral Variables (BAHAVE-AD Scale) [ Time Frame: Baseline, 14 days follow-up] ]
8. Change From Baseline in Cognitive Function (Digit Symbol Substitution Test) [ Time Frame: Baseline, 14 days follow-up] ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Locations

Brazil

Brasilia University; Recruiting

Brasilia, Distrito Federal, Brazil, 70840

Contact: Francisca M Scoralick franciscascoralick@gmail.com

Sub-Investigator: Francisca M Scoralick

Sponsors and Collaborators

Brasilia University Hospital

Investigators

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

More Information

• Responsible Party: Einstein Francisco de Camargos, Medical Doctor, Brasilia University Hospital
• ClinicalTrials.gov Identifier: NCT01867775
• Other Study ID Numbers: 052/2012
• First Posted: June 4, 2013
• Last Update Posted: June 4, 2013
• Last Verified: May 2013

Keywords provided by Einstein Francisco de Camargos, Brasilia University Hospital:

Alzheimer's disease; Sleep disorders; Mirtazapine; Treatment; Intervention; insomnia

Additional relevant MeSH terms:

Alzheimer Disease; Sleep Wake Disorders; Parasomnias; Disease; Pathologic Processes; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Mirtazapine; Antidepressive Agents; Psychotropic Drugs; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Adrenergic alpha-2 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists