Trazodone for Sleep Disorders in Alzheimer's Disease

NCT01142258 | Completed Phase 3

• 1 other identifier: TZD-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep; Sleep Disorders; Insomnia; Alzheimer's Disease

Keywords

Sleep Disturbances; Alzheimer disease; Insomnia; Trazodone; Treatment

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Nighttime Total Sleep Time

  Baseline, 14 days follow-up

Secondary Outcomes (10)

• Change from Baseline in Nighttime Wake After Sleep Onset

  Baseline, 14 days follow-up

• Change from Baseline in Nighttime Number Of Awakenings

  Baseline, 14 days follow-up

• Change from Baseline in Daytime Total Sleep Time

  Baseline, 14 days follow-up

• Change from Baseline in Number of Daytime Naps

  Baseline, 14 days follow-up

• change in cognitive function (as measured by the Mini-Mental State Examination)

  Baseline, 14 days follow-up

Study Arms (2)

Trazodone

EXPERIMENTAL

Study group will receive trazodone 50mg

Drug: Trazodone

Placebo

PLACEBO COMPARATOR

Inert pill

Drug: Placebo

Interventions

Trazodone DRUG

Trazodone tablets, 50 mg, 10pm (before bedtime) for 14 days.

Trazodone

Placebo DRUG

Inactive or inert pill which will be used as a comparator

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Brasilia University Hospital: lead
• Universidade Federal do Paraná: collaborator

Study Sites (1)

Geriatric Medical Centre

Brasília, Federal District, Brazil

Location

Related Publications (2)

• McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.

  PMID: 33189083 DERIVED

• Camargos EF, Louzada LL, Quintas JL, Naves JO, Louzada FM, Nobrega OT. Trazodone improves sleep parameters in Alzheimer disease patients: a randomized, double-blind, and placebo-controlled study. Am J Geriatr Psychiatry. 2014 Dec;22(12):1565-74. doi: 10.1016/j.jagp.2013.12.174. Epub 2014 Jan 4.

  PMID: 24495406 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Alzheimer Disease; Parasomnias

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Officials

• Einstein F Camargos, MD, MsC

  Brasilia University - Brasilia's University Hospital - Geriatric Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 11, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

BR (1)