Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
62 participants
INTERVENTIONAL
2016-10-31
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Zolpidem
Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights
Zolpidem
Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights
Zoplicone
Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights
Zoplicone
Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights
Placebo
Study group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights
Placebo
Inactive or inert pill which will be used as a comparator
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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Brasilia University Hospital
OTHER
Responsible Party
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Einstein Francisco de Camargos
Principal Investigator
Principal Investigators
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Luciana L. Louzada, MD, MsC
Role: PRINCIPAL_INVESTIGATOR
Brasilia University - Brasilia's University Hospital - Geriatric Medical Center
Locations
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Geriatric Medical Centre
BrasÃlia, Federal District, Brazil
Countries
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References
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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.
Other Identifiers
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ZOLP-001
Identifier Type: -
Identifier Source: org_study_id