Z-Drugs for Sleep Disorders in Alzheimer's Disease

Sponsor

Brasilia University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03075241

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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)

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 Design

Study Type:

Interventional

Actual Enrollment :

62 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 Randomized, Triple-blind, Placebo-controlled Study

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Apr 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Nighttime Total Sleep Time [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

Daytime Total Sleep Time [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 [Baseline, 14 days follow-up]
Daytime Total Sleep Time / Nighttime Total Sleep Time
Nighttime Wake after Sleep Onset [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 [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 [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. [Baseline, 14 days follow-up]
Analyze possible differences between sleep efficiency between the two treatments after 2 weeks under treatment
Nighttime Number of Awakenings [Baseline, 14 days follow-up]
Change in scores of nighttime number of awakenings from baseline to intervention weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts 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