SleepPhase 3NCT03075241
Z-Drugs for Sleep Disorders in Alzheimer's Disease
A Phase 3 study testing Zolpidem and Zoplicone in people with Sleep and Sleep Disorders, run by Brasilia University Hospital at 1 site in Brazil.
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) Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Sleep, Sleep Disorders, Insomnia
- What is being tested?
- Zolpidem and Zoplicone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2016to Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Z-Drugs for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Triple-blind, Placebo-controlled Study
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)
Read the 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.
- Conditions
- Sleep, Sleep Disorders, Insomnia, Alzheimer's Disease
- Being tested
- Zolpidem, Zoplicone, Placebo
- Keywords
- Sleep Disturbances, Alzheimer Disease, Insomnia, Z-Drugs, Treatment
- Medical subject headings
- Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders, Alzheimer Disease, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights
ZopliconeDrug
Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights
PlaceboDrug
Inactive or inert pill which will be used as a comparator
| Study group | Role | What they receive |
|---|---|---|
| Zolpidem | Experimental | Study group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights Receives: Drug: Zolpidem |
| Zoplicone | Experimental | Study group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nighttime Total Sleep Time
Mean Total Sleep Time (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
Measured: Baseline, 14 days follow-up
Secondary outcomes (7)
Daytime Total Sleep Time
Daytime Total Sleep Time (in minutes) during the 12h daytime period (8:00am-8:00pm) after 2 weeks under treatment
Measured: Baseline, 14 days follow-up
Ratio of daytime to nighttime sleep
Daytime Total Sleep Time / Nighttime Total Sleep Time
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 14 days follow-up
Nighttime Number of Awakenings
Change in scores of nighttime number of awakenings from baseline to intervention weeks
Measured: Baseline, 14 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startOct 2016
- Primary completionApr 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Einstein Francisco de Camargos, Brasilia University Hospital
- Investigators
- Luciana L. Louzada, MD, MsC, Principal investigator, Brasilia University - Brasilia's University Hospital - Geriatric Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075241
- Sponsor's protocol ID
- ZOLP-001
- Status last verified
- Nov 2020
- First submitted
- 5 Mar 2017
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34635802
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z-Drugs for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Triple-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03075241
- Acronym / sponsor ID
- ZOLP-001
- Conditions
- Sleep, Sleep Disorders, Insomnia, Alzheimer's Disease
- Keywords
- Sleep Disturbances, Alzheimer Disease, Insomnia, Z-Drugs, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zolpidem | Experimental | Drug: ZolpidemStudy group will receive zolpidem 10mg capsules, 10pm (before bedtime) for 14 nights |
| Zoplicone | Experimental | Drug: ZopliconeStudy group will receive zoplicone 7.5mg capsules, 10pm (before bedtime) for 14 nights |
| Placebo | Placebo comparator | Drug: PlaceboStudy group will receive inactive or inert capsules, which will be used as a comparator, 10pm (before bedtime) for 14 nights |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZolpidemZolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights | Drug | Zolpidem |
| ZopliconeZoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights | Drug | Zoplicone |
| PlaceboInactive or inert pill which will be used as a comparator | Drug | Placebo |
Primary outcome
Nighttime Total Sleep Time
Time frame: Baseline, 14 days follow-up
Mean Total Sleep Time (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment
7 secondary outcomes
Daytime Total Sleep Time
Time frame: Baseline, 14 days follow-up
Ratio of daytime to nighttime sleep
Time frame: Baseline, 14 days follow-up
Nighttime Wake after Sleep Onset
Time frame: Baseline, 14 days follow-up
Proportion of sleep time at nighttime
Time frame: Baseline, 14 days follow-up
Proportion of patients with gain of at least 30 minutes in Total Sleep Time
Time frame: Baseline, 14 days follow-up
Differences between sleep efficiency between the two treatments.
Time frame: Baseline, 14 days follow-up
Nighttime Number of Awakenings
Time frame: Baseline, 14 days follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 34635802Louzada 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.
- Individual participant dataSharing planned: No
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana L. Louzada, MD, MsC principal investigator
Brasilia University - Brasilia's University Hospital - Geriatric Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zolpidem and Zoplicone in people with Sleep and Sleep Disorders, run by Brasilia University Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nighttime Total Sleep Time (time frame: Baseline, 14 days follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.