Mirtazapine for Sleep Disorders in Alzheimer's Disease

NCT01867775 | Unknown Phase 3

• 1 other identifier: 052/2012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease; Sleep Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Change From Baseline in Nighttime Number Of Awakenings

  Baseline, 14 days follow-up

• Change From Baseline in Nighttime Wake After Sleep Onset

  Baseline, 14 days follow-up

• Change From Baseline in in Daytime Total Sleep Time

  Baseline, 14 days follow-up

• Change From Baseline in Number of Daytime Naps

  Baseline, 14 days follow-up]

• Change in Cognitive Function (as Measured by the Mini-Mental State Examination)

  Baseline, 14 days follow-up]

Study Arms (2)

Mirtazapine

ACTIVE COMPARATOR

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

Drug: Mirtazapine

Placebo

PLACEBO COMPARATOR

Placebo 15 mg, once a day at night for 14 days

Interventions

Mirtazapine DRUG

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

Also known as: Remeron

Mirtazapine

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Brasilia University Hospital: lead

Study Sites (1)

Brasilia University

Brasília, Federal District, 70840, Brazil

RECRUITING

Related Publications (1)

• McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.

  PMID: 33189083 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Francisca M Scoralick, MD

  University of Brasilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 4, 2013
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: June 4, 2013

Record last verified: 2013-05

Locations

BR (1)