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Trazodone for Sleep Disorders in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT01142258
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : October 15, 2012
Sponsor:
Collaborator:
Universidade Federal do Paraná
Information provided by (Responsible Party):
Einstein Francisco de Camargos, Brasilia University Hospital

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : March 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change from Baseline in Nighttime Total Sleep Time [ Time Frame: Baseline, 14 days follow-up ]

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

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142258


Locations
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Brazil
Geriatric Medical Centre
Brasilia, Distrito Federal, Brazil
Sponsors and Collaborators
Brasilia University Hospital
Universidade Federal do Paraná
Investigators
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Principal Investigator: Einstein F Camargos, MD, MsC Brasilia University - Brasilia's University Hospital - Geriatric Medical Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Einstein Francisco de Camargos, MD, Brasilia University Hospital
ClinicalTrials.gov Identifier: NCT01142258    
Other Study ID Numbers: TZD-001
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012
Keywords provided by Einstein Francisco de Camargos, Brasilia University Hospital:
Sleep Disturbances
Alzheimer disease
Insomnia
Trazodone
Treatment
Additional relevant MeSH terms:
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Alzheimer Disease
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Parasomnias
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Neurologic Manifestations
 Trazodone
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
Antidepressive Agents, Second-Generation
Antidepressive Agents