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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 : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Einstein Francisco de Camargos, Brasilia University Hospital

Tracking Information
First Submitted Date  ICMJE March 5, 2017
First Posted Date  ICMJE March 9, 2017
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03075241 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2017)
  • Nighttime Number of Awakenings [ Time Frame: Baseline, 14 days follow-up ]
    Change in scores from baseline to intervention week
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Z-Drugs for Sleep Disorders in Alzheimer's Disease
Official Title  ICMJE Z-Drugs for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomised, Double-blind, Placebo-controlled Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep
  • Sleep Disorders
  • Insomnia
  • Alzheimer's Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Zolpidem
    Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights
    Intervention: Drug: Zolpidem
  • Experimental: Zoplicone
    Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights
    Intervention: Drug: Zoplicone
  • Placebo Comparator: Placebo
    Study group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Flávio Vieira, MD, MsC 55 61 996304041 flaviovum@yahoo.com.br
Contact: Einstein F. Camargos, MD, MsC 55 61 99798345 einsteinfc@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03075241
Other Study ID Numbers  ICMJE ZOLP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Einstein Francisco de Camargos, Brasilia University Hospital
Study Sponsor  ICMJE Brasilia University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luciana L. Louzada, MD, MsC Brasilia University - Brasilia's University Hospital - Geriatric Medical Center
PRS Account Brasilia University Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP