Trazodone for Sleep Disorders in Alzheimer's Disease

Inclusion Criteria:

• Fifty-five years of age or older;

• Diagnosis of probable Alzheimer's disease by National Institute of Neurological andCommunicative Disorders and Stroke/the Alzheimer's Disease and Related DisordersAssociation 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 atleast 7 nights of complete actigraph data collected over a single week;

• For-week history of sleep disorder behaviors, occurring at least once weekly, asreported by the caregiver using the Neuropsychiatric Inventory (NPI) NighttimeBehavior scale;

• Sleep disturbance observed was not present before the diagnosis of AD;

• Other co-morbidities, especially delirium, depression, chronic pain and medication usemay be present, but do not cooperate in the primary symptoms;

• Computed tomography or magnetic resonance imaging since the onset of memory problemsshowing no more than 1 lacunar infarct in a nonstrategic area and no clinical eventssuggestive 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 ispresent during the night and would agree to assume the role of the principal caregiverfor 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 affectactigraphic differentiation of sleep and wakefulness

• Severe agitation;

• Unstable medical condition;

• Discontinuation of psychotropic or sleep medications within 2 weeks of the screeningvisit;

• Patient unwilling to maintain caffeine abstinence after 2:00 PM for the duration ofthe protocol;

• Patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, andonly 1 alcoholic drink after 6:00 PM for the duration of the protocol;

• Prior use of trazodone for the treatment of sleep disturbances;

• Caregiver deemed too unreliable to supervise the wearing of the actigraph, toadminister trazodone the proper time, to maintain tbe sleep diary, or to bring thepatient to the scheduled visits;