Trazodone for Sleep Disorders in Alzheimer's Disease

Sponsor

Brasilia University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01142258

Collaborator

Universidade Federal do Paraná (Other)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sleep Sleep Disorders Insomnia Alzheimer's Disease	Drug: Trazodone Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trazodone Study group will receive trazodone 50mg	Drug: Trazodone Trazodone tablets, 50 mg, 10pm (before bedtime) for 14 days.
Placebo Comparator: Placebo Inert pill	Drug: Placebo Inactive or inert pill which will be used as a comparator

Arm

Intervention/Treatment

Experimental: Trazodone

Study group will receive trazodone 50mg

Drug: Trazodone

Trazodone tablets, 50 mg, 10pm (before bedtime) for 14 days.

Placebo Comparator: Placebo

Inert pill

Drug: Placebo

Inactive or inert pill which will be used as a comparator

Outcome Measures

Primary Outcome Measures

Change from Baseline in Nighttime Total Sleep Time [Baseline, 14 days follow-up]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;