Z-Drugs for Sleep Disorders in Alzheimer's Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep, Sleep Disorders, Insomnia, Alzheimer's Disease

Intervention / Treatment
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* Drug: Zolpidem
* Drug: Zoplicone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zolpidem<br>Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights | Drug: Zolpidem<br>* Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights<br>|
| Experimental: Zoplicone<br>Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights | Drug: Zoplicone<br>* Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights<br>|
| Placebo Comparator: Placebo<br>Study group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights | Drug: Placebo<br>* Inactive or inert pill which will be used as a comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nighttime Total Sleep Time | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime Total Sleep Time | 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 | Daytime Total Sleep Time / Nighttime Total Sleep Time | Baseline, 14 days follow-up | 
| 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 | Baseline, 14 days follow-up | 
| Proportion of sleep time at nighttime | 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 | 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. | Analyze possible differences between sleep efficiency between the two treatments after 2 weeks under treatment | Baseline, 14 days follow-up | 
| Nighttime Number of Awakenings | Change in scores of nighttime number of awakenings from baseline to intervention weeks | Baseline, 14 days follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Disturbances, Alzheimer Disease, Insomnia, Z-Drugs, Treatment