Clinical trial NCT03075241: Z-Drugs for Sleep Disorders in Alzheimer's Disease
Official title: Z-Drugs for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Triple-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sleep
Sleep Disorders
Insomnia
Alzheimer's Disease
Keywords: Sleep Disturbances
Alzheimer Disease
Insomnia
Z-Drugs
Treatment
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 62
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Nighttime Total Sleep Time
timeFrame: Baseline, 14 days follow-up
Secondary outcomes:
measure: Daytime Total Sleep Time
timeFrame: Baseline, 14 days follow-up
measure: Ratio of daytime to nighttime sleep
timeFrame: Baseline, 14 days follow-up
measure: Nighttime Wake after Sleep Onset
timeFrame: Baseline, 14 days follow-up
measure: Proportion of sleep time at nighttime
timeFrame: Baseline, 14 days follow-up
measure: Proportion of patients with gain of at least 30 minutes in Total Sleep Time
timeFrame: Baseline, 14 days follow-up
measure: Differences between sleep efficiency between the two treatments.
timeFrame: Baseline, 14 days follow-up
measure: Nighttime Number of Awakenings
timeFrame: Baseline, 14 days follow-up
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Geriatric Medical Centre
state: Distrito Federal
Study officials:
affiliation: Brasilia University - Brasilia's University Hospital - Geriatric Medical Center
name: Luciana L. Louzada, MD, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Louzada LL, Machado FV, Quintas JL, Ribeiro GA, Silva MV, Mendonca-Silva DL, Goncalves BSB, Nobrega OT, Camargos EF. The efficacy and safety of zolpidem and zopiclone to treat insomnia in Alzheimer's disease: a randomized, triple-blind, placebo-controlled trial. Neuropsychopharmacology. 2022 Jan;47(2):570-579. doi: 10.1038/s41386-021-01191-3. Epub 2021 Oct 11.