Trazodone for Sleep Disorders in Alzheimer's Disease

Condition(s) targeted: Sleep; Sleep Disorders; Insomnia; Alzheimer's Disease

Intervention: Trazodone (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Brasilia University Hospital

Official(s) and/or principal investigator(s):
Einstein F Camargos, MD, MsC, Principal Investigator, Affiliation: Brasilia University - Brasilia's University Hospital - Geriatric Medical Centre

The purpose of this study is to determine whether trazodone is effective in the treatment of sleep disorders in Alzheimer's disease (AD).

Official title: Trazodone for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomised, Double-blind, Placebo-controlled Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change from Baseline in Nighttime Total Sleep Time

Secondary outcome:

Change from Baseline in Nighttime Wake After Sleep Onset

Change from Baseline in Nighttime Number Of Awakenings

Change from Baseline in Daytime Total Sleep Time

Change from Baseline in Number of Daytime Naps

change in cognitive function (as measured by the Mini-Mental State Examination)

Change in activities of daily living (The index of ADL - Katz)

Change of baseline in behavioral variables (BAHAVE-AD scale)

Proportion of subjects who gained at least 30 minutes in total nighttime sleep

Change from Baseline in Clinical Dementia Rating

Change from Baseline in cognitive function (Digit Symbol Substitution Test)

Detailed description: Sleep disorders (SD) affects 35 to 50 percent of patients with AD. These disorders often make caring for patients at home very difficult. Trazodone is commonly prescribed drugs for SD in AD patients. There are no controlled studies in this sample of patients for this purpose.

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

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 trazodone 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;

Geriatric Medical Centre, Brasilia, Distrito Federal, Brazil

Starting date: March 2010
Last updated: October 12, 2012