Trazodone for Sleep Disorders in Alzheimer's Disease

B

Brasilia University Hospital

Status and phase

Completed
Phase 3

Conditions

Sleep Disorders
Alzheimer's Disease
Insomnia
Sleep

Treatments

Drug: Trazodone
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01142258
TZD-001

Details and patient eligibility

About

The purpose of this study is to determine whether trazodone is effective in the treatment of sleep disorders in Alzheimer's disease (AD).

Full 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.

Enrollment

40 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups, including a placebo group

Trazodone
Experimental group
Description:
Study group will receive trazodone 50mg
Treatment:
Drug: Trazodone
Placebo
Placebo Comparator group
Description:
Inert pill
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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