Z-Drugs for Sleep Disorders in Alzheimer’s Disease

Overview

The purpose of this study is to determine whether Zolpidem and Zoplicone are efective in the treatment of sleep disorders in Alzheimer's disease (AD)

Full Title of Study: “Z-Drugs for the Treatment of Sleep Disorders in Alzheimer’s Disease: a Randomized, Triple-blind, Placebo-controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: April 2020

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. Zolpidem and Zoplicone are prescribed drugs for sleep disorder in AD patients.

Interventions

  • Drug: Zolpidem
    • Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights
  • Drug: Zoplicone
    • Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights
  • Drug: Placebo
    • Inactive or inert pill which will be used as a comparator

Arms, Groups and Cohorts

  • Experimental: Zolpidem
    • Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights
  • Experimental: Zoplicone
    • Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights
  • Placebo Comparator: Placebo
    • Study group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights

Clinical Trial Outcome Measures

Primary Measures

  • Nighttime Total Sleep Time
    • Time Frame: Baseline, 14 days follow-up
    • Mean Total Sleep Time (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment

Secondary Measures

  • Daytime Total Sleep Time
    • Time Frame: Baseline, 14 days follow-up
    • Daytime Total Sleep Time (in minutes) during the 12h daytime period (8:00am-8:00pm) after 2 weeks under treatment
  • Ratio of daytime to nighttime sleep
    • Time Frame: Baseline, 14 days follow-up
    • Daytime Total Sleep Time / Nighttime Total Sleep Time
  • Nighttime Wake after Sleep Onset
    • Time Frame: Baseline, 14 days follow-up
    • Nighttime Wake after Sleep Onset (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
  • Proportion of sleep time at nighttime
    • Time Frame: Baseline, 14 days follow-up
    • Proportion of sleep time (%) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
  • Proportion of patients with gain of at least 30 minutes in Total Sleep Time
    • Time Frame: Baseline, 14 days follow-up
    • Proportion of patients with gain of at least 30 minutes in Total Sleep Time after 2 weeks under treatment
  • Differences between sleep efficiency between the two treatments.
    • Time Frame: Baseline, 14 days follow-up
    • Analyze possible differences between sleep efficiency between the two treatments after 2 weeks under treatment
  • Nighttime Number of Awakenings
    • Time Frame: Baseline, 14 days follow-up
    • Change in scores of nighttime number of awakenings from baseline to intervention weeks

Participating in This Clinical Trial

Inclusion Criteria

  • 55 years of age or older – Diagnosis of probable Alzheimer's disease (AD) by National Institute of Neurological and Communicative Disorders and Stroke / the Alzheimer's Disease and Related Disorders Association Criteria – Hachinski Ischemia Scale less than 5 – Mini-Mental State Examination score of 0 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 – Four-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 infract 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 principle 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 medication within 2 weeks of the screening visit – Patient unwilling to maintain caffeine abstinence after 2:00pm 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 6:00pm for the duration of the protocolo – Prior use of zolpidem/zoplicone for the treatment os sleep disturbances – Caregiver deemed to be unreliable to supervise the wearing of the actigraph, to administer study capsules at the proper time, to maintain the sleep diary, or to bring the patient to the scheduled visits

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brasilia University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Einstein Francisco de Camargos, Principal Investigator – Brasilia University Hospital
  • Overall Official(s)
    • Luciana L. Louzada, MD, MsC, Principal Investigator, Brasilia University – Brasilia’s University Hospital – Geriatric Medical Center

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