Trazodone for Sleep Disorders in Alzheimer's Disease
Information source: Brasilia University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep; Sleep Disorders; Insomnia; Alzheimer's Disease
Intervention: Trazodone (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Brasilia University Hospital Official(s) and/or principal investigator(s): Einstein F Camargos, MD, MsC, Principal Investigator, Affiliation: Brasilia University - Brasilia's University Hospital - Geriatric Medical Centre
Summary
The purpose of this study is to determine whether trazodone is effective in the treatment of
sleep disorders in Alzheimer's disease (AD).
Clinical Details
Official title: Trazodone for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomised, Double-blind, Placebo-controlled Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change from Baseline in Nighttime Total Sleep Time
Secondary outcome: Change from Baseline in Nighttime Wake After Sleep OnsetChange from Baseline in Nighttime Number Of Awakenings Change from Baseline in Daytime Total Sleep Time Change from Baseline in Number of Daytime Naps change in cognitive function (as measured by the Mini-Mental State Examination) Change in activities of daily living (The index of ADL - Katz) Change of baseline in behavioral variables (BAHAVE-AD scale) Proportion of subjects who gained at least 30 minutes in total nighttime sleep Change from Baseline in Clinical Dementia Rating Change from Baseline in cognitive function (Digit Symbol Substitution Test)
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
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
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;
Locations and Contacts
Geriatric Medical Centre, Brasilia, Distrito Federal, Brazil
Additional Information
Starting date: March 2010
Last updated: October 12, 2012
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