Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2010-03-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Trazodone
Study group will receive trazodone 50mg
Trazodone
Trazodone tablets, 50 mg, 10pm (before bedtime) for 14 days.
Placebo
Inert pill
Placebo
Inactive or inert pill which will be used as a comparator
Interventions
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Trazodone
Trazodone tablets, 50 mg, 10pm (before bedtime) for 14 days.
Placebo
Inactive or inert pill which will be used as a comparator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
55 Years
ALL
No
Sponsors
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Universidade Federal do Paraná
OTHER
Brasilia University Hospital
OTHER
Responsible Party
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Einstein Francisco de Camargos
MD
Principal Investigators
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Einstein F Camargos, MD, MsC
Role: PRINCIPAL_INVESTIGATOR
Brasilia University - Brasilia's University Hospital - Geriatric Medical Centre
Locations
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Geriatric Medical Centre
BrasÃlia, Federal District, Brazil
Countries
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References
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McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
Camargos EF, Louzada LL, Quintas JL, Naves JO, Louzada FM, Nobrega OT. Trazodone improves sleep parameters in Alzheimer disease patients: a randomized, double-blind, and placebo-controlled study. Am J Geriatr Psychiatry. 2014 Dec;22(12):1565-74. doi: 10.1016/j.jagp.2013.12.174. Epub 2014 Jan 4.
Other Identifiers
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TZD-001
Identifier Type: -
Identifier Source: org_study_id