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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zolpidem | Experimental | Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights |
|
| Zoplicone | Experimental | Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights |
|
| Placebo | Placebo Comparator | Study group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolpidem | Drug | Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luciana L. Louzada, MD, MsC | Brasilia University - Brasilia's University Hospital - Geriatric Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric Medical Centre | BrasÃlia | Federal District | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34635802 | Derived | 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. |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000544 | Alzheimer Disease |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Zoplicone |
| Drug |
Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights |
|
| Placebo | Drug | Inactive or inert pill which will be used as a comparator |
|
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 |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |