Trazodone for Sleep Disorders in Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Universidade Federal do Paraná
Information provided by (Responsible Party):
Einstein Francisco de Camargos, Brasilia University Hospital
ClinicalTrials.gov Identifier:
NCT01142258
First received: June 9, 2010
Last updated: October 12, 2012
Last verified: October 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Nighttime Wake After Sleep Onset [ Time Frame: Baseline, 14 days follow-up ] [ Designated as safety issue: No ]
  • Change from Baseline in Nighttime Number Of Awakenings [ Time Frame: Baseline, 14 days follow-up ] [ Designated as safety issue: No ]
  • Change from Baseline in Daytime Total Sleep Time [ Time Frame: Baseline, 14 days follow-up ] [ Designated as safety issue: No ]
  • Change from Baseline in Number of Daytime Naps [ Time Frame: Baseline, 14 days follow-up ] [ Designated as safety issue: No ]
  • change in cognitive function (as measured by the Mini-Mental State Examination) [ Time Frame: Baseline, 14 days follow-up ] [ Designated as safety issue: Yes ]
  • Change in activities of daily living (The index of ADL - Katz) [ Time Frame: Baseline, 14 days follow-up ] [ Designated as safety issue: Yes ]
  • Change of baseline in behavioral variables (BAHAVE-AD scale) [ Time Frame: Baseline, 14 days follow-up ] [ Designated as safety issue: Yes ]
  • Proportion of subjects who gained at least 30 minutes in total nighttime sleep [ Time Frame: Baseline, 14 days follow-up ] [ Designated as safety issue: No ]
  • Change from Baseline in Clinical Dementia Rating [ Time Frame: Baseline, 14 days follow-up ] [ Designated as safety issue: Yes ]
  • Change from Baseline in cognitive function (Digit Symbol Substitution Test) [ Time Frame: Baseline, 14 days follow-up ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142258

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

No publications provided

Responsible Party: Einstein Francisco de Camargos, MD, Brasilia University Hospital
ClinicalTrials.gov Identifier: NCT01142258     History of Changes
Other Study ID Numbers: TZD-001
Study First Received: June 9, 2010
Last Updated: October 12, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Brasilia University Hospital:
Sleep Disturbances
Alzheimer disease
Insomnia
Trazodone
Treatment

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Alzheimer Disease
Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on October 19, 2014