Z-Drugs for Sleep Disorders in Alzheimer's Disease

NCT03075241 | Completed Phase 3

• 1 other identifier: ZOLP-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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)

Conditions

Sleep; Sleep Disorders; Insomnia; Alzheimer's Disease

Keywords

Sleep Disturbances; Alzheimer Disease; Insomnia; Z-Drugs; Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Daytime Total Sleep Time

  Baseline, 14 days follow-up

• Ratio of daytime to nighttime sleep

  Baseline, 14 days follow-up

• Nighttime Wake after Sleep Onset

  Baseline, 14 days follow-up

• Proportion of sleep time at nighttime

  Baseline, 14 days follow-up

• Proportion of patients with gain of at least 30 minutes in Total Sleep Time

  Baseline, 14 days follow-up

Study Arms (3)

Zolpidem

EXPERIMENTAL

Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights

Drug: Zolpidem

Zoplicone

EXPERIMENTAL

Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights

Drug: Zoplicone

Placebo

PLACEBO COMPARATOR

Study group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights

Drug: Placebo

Interventions

Zolpidem DRUG

Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights

Zolpidem

Zoplicone DRUG

Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights

Zoplicone

Placebo DRUG

Inactive or inert pill which will be used as a comparator

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brasilia University Hospital: lead

Study Sites (1)

Geriatric Medical Centre

Brasília, Federal District, Brazil

Location

Related Publications (1)

• 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.

  PMID: 34635802 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Alzheimer Disease; Parasomnias

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Luciana L. Louzada, MD, MsC

  Brasilia University - Brasilia's University Hospital - Geriatric Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 5, 2017
• First Posted: March 9, 2017
• Study Start: October 1, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)