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Trazodone for Sleep Disorders in Alzheimer's Disease

This study has been completed.
Universidade Federal do Paraná
Information provided by (Responsible Party):
Einstein Francisco de Camargos, Brasilia University Hospital Identifier:
First received: June 9, 2010
Last updated: October 12, 2012
Last verified: October 2012
The purpose of this study is to determine whether trazodone is effective in the treatment of sleep disorders in Alzheimer's disease (AD).

Condition Intervention Phase
Sleep Disorders
Alzheimer's Disease
Drug: Trazodone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Brasilia University Hospital:

Primary Outcome Measures:
  • Change from Baseline in Nighttime Total Sleep Time [ Time Frame: Baseline, 14 days follow-up ]

Secondary Outcome Measures:
  • Change from Baseline in Nighttime Wake After Sleep Onset [ Time Frame: Baseline, 14 days follow-up ]
  • Change from Baseline in Nighttime Number Of Awakenings [ Time Frame: Baseline, 14 days follow-up ]
  • Change from Baseline in Daytime Total Sleep Time [ Time Frame: Baseline, 14 days follow-up ]
  • Change from Baseline in Number of Daytime Naps [ Time Frame: Baseline, 14 days follow-up ]
  • change in cognitive function (as measured by the Mini-Mental State Examination) [ Time Frame: Baseline, 14 days follow-up ]
  • Change in activities of daily living (The index of ADL - Katz) [ Time Frame: Baseline, 14 days follow-up ]
  • Change of baseline in behavioral variables (BAHAVE-AD scale) [ Time Frame: Baseline, 14 days follow-up ]
  • Proportion of subjects who gained at least 30 minutes in total nighttime sleep [ Time Frame: Baseline, 14 days follow-up ]
  • Change from Baseline in Clinical Dementia Rating [ Time Frame: Baseline, 14 days follow-up ]
  • Change from Baseline in cognitive function (Digit Symbol Substitution Test) [ Time Frame: Baseline, 14 days follow-up ]

Enrollment: 40
Study Start Date: March 2010
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
  Contacts and Locations
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Please refer to this study by its identifier: NCT01142258

Geriatric Medical Centre
Brasilia, Distrito Federal, Brazil
Sponsors and Collaborators
Brasilia University Hospital
Universidade Federal do Paraná
Principal Investigator: Einstein F Camargos, MD, MsC Brasilia University - Brasilia's University Hospital - Geriatric Medical Centre
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Einstein Francisco de Camargos, MD, Brasilia University Hospital Identifier: NCT01142258     History of Changes
Other Study ID Numbers: TZD-001
Study First Received: June 9, 2010
Last Updated: October 12, 2012

Keywords provided by Brasilia University Hospital:
Sleep Disturbances
Alzheimer disease

Additional relevant MeSH terms:
Alzheimer Disease
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Neurologic Manifestations
Signs and Symptoms
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents processed this record on April 25, 2017