Z-Drugs for Sleep Disorders in Alzheimer's Disease

November 8, 2020 updated by: Einstein Francisco de Camargos, Brasilia University Hospital

Z-Drugs for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Triple-blind, Placebo-controlled Study

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil
        • Geriatric Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Zolpidem
Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights
Drug: Zolpidem
Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights
Experimental: Zoplicone
Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights
Drug: Zoplicone
Zoplicone tablets, 7.5mg, 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
Drug: Placebo
Inactive or inert pill which will be used as a comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 14 days follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 14 days follow-up
Ratio of daytime to nighttime sleep
Time Frame: Baseline, 14 days follow-up
Daytime Total Sleep Time / Nighttime Total Sleep Time
Baseline, 14 days follow-up
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
Baseline, 14 days follow-up
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
Baseline, 14 days follow-up
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
Baseline, 14 days follow-up
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
Baseline, 14 days follow-up
Nighttime Number of Awakenings
Time Frame: Baseline, 14 days follow-up
Change in scores of nighttime number of awakenings from baseline to intervention weeks
Baseline, 14 days follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brasilia University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luciana L. Louzada, MD, MsC, Brasilia University - Brasilia's University Hospital - Geriatric Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZOLP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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