Z-Drugs for Sleep Disorders in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075241
• Other study ID #: ZOLP-001
• Status: Completed
• Phase: Phase 3
• Start date: October 2016
• Est. completion date: April 2020

Study information

• Verified date: November 2020
• Source: Brasilia University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Insomnia
• Parasomnias
• Sleep
• Sleep Disorders
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Drug:
• Zolpidem
Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights
• Zoplicone
Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights
• Placebo
Inactive or inert pill which will be used as a comparator

Locations

Country	Name	City	State
Brazil	Geriatric Medical Centre	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Ratio of daytime to nighttime sleep	Daytime Total Sleep Time / Nighttime Total Sleep Time	Baseline, 14 days follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Nighttime Number of Awakenings	Change in scores of nighttime number of awakenings from baseline to intervention weeks	Baseline, 14 days follow-up