NCT01142258
Completed
Phase 3
Trazodone for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomised, Double-blind, Placebo-controlled Study
Brasilia University Hospital1 site in 1 country40 target enrollmentMarch 2010
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Sleep
- Sponsor
- Brasilia University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Nighttime Total Sleep Time
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to determine whether trazodone is effective in the treatment of sleep disorders in Alzheimer's disease (AD).
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.
Investigators
Einstein Francisco de Camargos
MD
Brasilia University Hospital
Eligibility 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;
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;
Arms & Interventions
Placebo
Inert pill
Intervention: Placebo
Trazodone
Study group will receive trazodone 50mg
Intervention: Trazodone
Outcomes
Primary Outcomes
Change from Baseline in Nighttime Total Sleep Time
Time Frame: Baseline, 14 days follow-up
Secondary Outcomes
- Change from Baseline in Nighttime Wake After Sleep Onset(Baseline, 14 days follow-up)
- Change from Baseline in Nighttime Number Of Awakenings(Baseline, 14 days follow-up)
- Change from Baseline 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)
- Change in activities of daily living (The index of ADL - Katz)(Baseline, 14 days follow-up)
- Change of baseline in behavioral variables (BAHAVE-AD scale)(Baseline, 14 days follow-up)
- Proportion of subjects who gained at least 30 minutes in total nighttime sleep(Baseline, 14 days follow-up)
- Change from Baseline in Clinical Dementia Rating(Baseline, 14 days follow-up)
- Change from Baseline in cognitive function (Digit Symbol Substitution Test)(Baseline, 14 days follow-up)
Study Sites (1)
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