Trazodone for Sleep Disorders in Alzheimer's Disease

Phase 3

Completed

• Conditions: Sleep; Sleep Disorders; Insomnia; Alzheimer's Disease
• Interventions: Drug: Trazodone; Drug: Placebo

• Registration Number: NCT01142258
• Lead Sponsor: Brasilia University Hospital

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2012-04
• Study Completion: 2012-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-12
• Last Update Posted: 2012-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trazodone	Trazodone	Study group will receive trazodone 50mg
Placebo	Placebo	Inert pill

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Nighttime Total Sleep Time	Baseline, 14 days follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Geriatric Medical Centre; 🇧🇷 Brasilia, Distrito Federal, Brazil