Mirtazapine for Sleep Disorders in Alzheimer's Disease

Inclusion Criteria: Fifty-five years of age or older; Diagnosis of probable Alzheimer's disease by NationalInstitute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Diseaseand Related Disorders Association criteria; Hachinski Ischemia Scale score less than 5Mini-Mental State Examination score of O to 26 Actigraph evidence of a mean time immobileof less than 7 hours per night based on at least 7 nights of complete actigraph datacollected over a single week; For-week history of sleep disorder behaviors, occurring atleast once weekly, as reported by the caregiver using the Neuropsychiatric Inventory (NPI)Nighttime Behavior scale; Sleep disturbance observed was not present before the diagnosisof AD; Other co-morbidities, especially delirium, depression, chronic pain and medicationuse may be present, but do not cooperate in the primary symptoms; Computed tomography ormagnetic resonance imaging since the onset of memory problems showing no more than 1lacunar infarct in a nonstrategic area and no clinical events suggestive of stroke or otherintracranial disease or normal; Stable medications for 4 weeks prior to the screeningvisit; Having a mobile upper extremity to which to attach an actigraph; Residing with aresponsible spouse, family member, or professional caregiver who is present during thenight and would agree to assume the role of the principal caregiver for the 3-weekprotocol; 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 actigraphicdifferentiation 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 theprotocol; 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 ofmirtazapine for the treatment of sleep disturbances; Caregiver deemed too unreliable tosupervise the wearing of the actigraph, to administer trazodone the proper time, tomaintain tbe sleep diary, or to bring the patient to the scheduled visits;