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Z-Drugs for Sleep Disorders in Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03075241
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Einstein Francisco de Camargos, Brasilia University Hospital

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)

Condition or disease Intervention/treatment Phase
Sleep Sleep Disorders Insomnia Alzheimer's Disease Drug: Zolpidem Drug: Zoplicone Drug: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Z-Drugs for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomised, Double-blind, Placebo-controlled Study
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. Ratio of daytime to nighttime sleep [ Time Frame: Baseline, 14 days follow-up ]
    Daytime Total Sleep Time / Nighttime Total Sleep Time

  3. 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

  4. 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

  5. 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

  6. 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

  7. Nighttime Number of Awakenings [ Time Frame: Baseline, 14 days follow-up ]
    Change in scores of nighttime number of awakenings from baseline to intervention weeks



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075241


Contacts
Contact: Flávio Vieira, MD, MsC 55 61 996304041 flaviovum@yahoo.com.br
Contact: Einstein F. Camargos, MD, MsC 55 61 99798345 einsteinfc@gmail.com

Locations
Brazil
Geriatric Medical Centre Recruiting
Brasilia, Distrito Federal, Brazil
Contact: Luciana L Louzada, MD, MsC    55 61 991197587    lucianaelouzada@gmail.com   
Sponsors and Collaborators
Brasilia University Hospital
Investigators
Principal Investigator: Luciana L. Louzada, MD, MsC Brasilia University - Brasilia's University Hospital - Geriatric Medical Center

Responsible Party: Einstein Francisco de Camargos, Principal Investigator, Brasilia University Hospital
ClinicalTrials.gov Identifier: NCT03075241     History of Changes
Other Study ID Numbers: ZOLP-001
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Einstein Francisco de Camargos, Brasilia University Hospital:
Sleep Disturbances
Alzheimer Disease
Insomnia
Z-Drugs
Treatment

Additional relevant MeSH terms:
Zolpidem
Hypnotics and Sedatives
Disease
Alzheimer Disease
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action