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Z-Drugs for Sleep Disorders in Alzheimer's Disease

Primary Purpose

Sleep, Sleep Disorders, Insomnia

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Zolpidem
Zoplicone
Placebo
Sponsored by
Brasilia University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep focused on measuring Sleep Disturbances, Alzheimer Disease, Insomnia, Z-Drugs, Treatment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geriatric Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Zolpidem

Zoplicone

Placebo

Arm Description

Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights

Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights

Study group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights

Outcomes

Primary Outcome Measures

Nighttime Total Sleep Time
Mean Total Sleep Time (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment

Secondary Outcome Measures

Daytime Total Sleep Time
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
Daytime Total Sleep Time / Nighttime Total Sleep Time
Nighttime Wake after Sleep Onset
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
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
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.
Analyze possible differences between sleep efficiency between the two treatments after 2 weeks under treatment
Nighttime Number of Awakenings
Change in scores of nighttime number of awakenings from baseline to intervention weeks

Full Information

First Posted
March 5, 2017
Last Updated
November 8, 2020
Sponsor
Brasilia University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03075241
Brief Title
Z-Drugs for Sleep Disorders in Alzheimer's Disease
Official Title
Z-Drugs for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Triple-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brasilia University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Sleep Disorders, Insomnia, Alzheimer's Disease
Keywords
Sleep Disturbances, Alzheimer Disease, Insomnia, Z-Drugs, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zolpidem
Arm Type
Experimental
Arm Description
Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights
Arm Title
Zoplicone
Arm Type
Experimental
Arm Description
Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights
Intervention Type
Drug
Intervention Name(s)
Zolpidem
Intervention Description
Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights
Intervention Type
Drug
Intervention Name(s)
Zoplicone
Intervention Description
Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inactive or inert pill which will be used as a comparator
Primary Outcome Measure Information:
Title
Nighttime Total Sleep Time
Description
Mean Total Sleep Time (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
Time Frame
Baseline, 14 days follow-up
Secondary Outcome Measure Information:
Title
Daytime Total Sleep Time
Description
Daytime Total Sleep Time (in minutes) during the 12h daytime period (8:00am-8:00pm) after 2 weeks under treatment
Time Frame
Baseline, 14 days follow-up
Title
Ratio of daytime to nighttime sleep
Description
Daytime Total Sleep Time / Nighttime Total Sleep Time
Time Frame
Baseline, 14 days follow-up
Title
Nighttime Wake after Sleep Onset
Description
Nighttime Wake after Sleep Onset (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
Time Frame
Baseline, 14 days follow-up
Title
Proportion of sleep time at nighttime
Description
Proportion of sleep time (%) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
Time Frame
Baseline, 14 days follow-up
Title
Proportion of patients with gain of at least 30 minutes in Total Sleep Time
Description
Proportion of patients with gain of at least 30 minutes in Total Sleep Time after 2 weeks under treatment
Time Frame
Baseline, 14 days follow-up
Title
Differences between sleep efficiency between the two treatments.
Description
Analyze possible differences between sleep efficiency between the two treatments after 2 weeks under treatment
Time Frame
Baseline, 14 days follow-up
Title
Nighttime Number of Awakenings
Description
Change in scores of nighttime number of awakenings from baseline to intervention weeks
Time Frame
Baseline, 14 days follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciana L. Louzada, MD, MsC
Organizational Affiliation
Brasilia University - Brasilia's University Hospital - Geriatric Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric Medical Centre
City
Brasilia
State/Province
Distrito Federal
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34635802
Citation
Louzada LL, Machado FV, Quintas JL, Ribeiro GA, Silva MV, Mendonca-Silva DL, Goncalves BSB, Nobrega OT, Camargos EF. The efficacy and safety of zolpidem and zopiclone to treat insomnia in Alzheimer's disease: a randomized, triple-blind, placebo-controlled trial. Neuropsychopharmacology. 2022 Jan;47(2):570-579. doi: 10.1038/s41386-021-01191-3. Epub 2021 Oct 11.
Results Reference
derived

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Z-Drugs for Sleep Disorders in Alzheimer's Disease

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