SleepPhase 3NCT01142258
Trazodone for Sleep Disorders in Alzheimer's Disease
A Phase 3 study testing Trazodone 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 trazodone is effective 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?
- Trazodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Aug 2012
- 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
- Fifty-five years of age or older;
- Diagnosis of probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Disease and Related Disorders Association criteria;
- Hachinski Ischemia Scale score less than 5
- Mini-Mental State Examination score of O 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;
- For-week history of sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver using the Neuropsychiatric Inventory (NPI) Nighttime Behavior scale;
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- 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 infarct 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 principal 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 medications within 2 weeks of the screening visit;
- Patient unwilling to maintain caffeine abstinence after 2:00 PM for the duration of the protocol;
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- Patient unwilling to comply with the maximum limit of 2 alcoholic drinks per day, and only 1 alcoholic drink after 6:00 PM for the duration of the protocol;
- Prior use of trazodone for the treatment of sleep disturbances;
- Caregiver deemed too unreliable to supervise the wearing of the actigraph, to administer trazodone the proper time, to maintain tbe 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: Trazodone for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomised, Double-blind, Placebo-controlled Study
The purpose of this study is to determine whether trazodone is effective 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. Trazodone is commonly prescribed drugs for SD in AD patients. There are no controlled studies in this sample of patients for this purpose.
- Conditions
- Sleep, Sleep Disorders, Insomnia, Alzheimer's Disease
- Being tested
- Trazodone, Placebo
- Keywords
- Sleep Disturbances, Alzheimer disease, Insomnia, Trazodone, 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.
TrazodoneDrug
Trazodone tablets, 50 mg, 10pm (before bedtime) for 14 days.
PlaceboDrug
Inactive or inert pill which will be used as a comparator
| Study group | Role | What they receive |
|---|---|---|
| Trazodone | Experimental | Study group will receive trazodone 50mg Receives: Drug: Trazodone |
| Placebo | Placebo comparator | Inert pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Nighttime Total Sleep Time
Measured: Baseline, 14 days follow-up
Secondary outcomes (10)
Change from Baseline in Nighttime Wake After Sleep Onset
Measured: Baseline, 14 days follow-up
Change from Baseline in Nighttime Number Of Awakenings
Measured: Baseline, 14 days follow-up
Change from Baseline in Daytime Total Sleep Time
Measured: Baseline, 14 days follow-up
Change from Baseline in Number of Daytime Naps
Measured: Baseline, 14 days follow-up
change in cognitive function (as measured by the Mini-Mental State Examination)
Measured: Baseline, 14 days follow-up
Change in activities of daily living (The index of ADL - Katz)
Measured: Baseline, 14 days follow-up
Change of baseline in behavioral variables (BAHAVE-AD scale)
Measured: Baseline, 14 days follow-up
Proportion of subjects who gained at least 30 minutes in total nighttime sleep
Measured: Baseline, 14 days follow-up
Change from Baseline in Clinical Dementia Rating
Measured: Baseline, 14 days follow-up
Change from Baseline in cognitive function (Digit Symbol Substitution Test)
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 posted11 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Paraná
- Responsible party
- Principal investigator, Einstein Francisco de Camargos, Brasilia University Hospital
- Investigators
- Einstein F Camargos, MD, MsC, Principal investigator, Brasilia University - Brasilia's University Hospital - Geriatric Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142258
- Sponsor's protocol ID
- TZD-001
- Status last verified
- Oct 2012
- First submitted
- 9 Jun 2010
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
PubMed 33189083Camargos EF, Louzada LL, Quintas JL, Naves JO, Louzada FM, Nobrega OT. Trazodone improves sleep parameters in Alzheimer disease patients: a randomized, double-blind, and placebo-controlled study. Am J Geriatr Psychiatry. 2014 Dec;22(12):1565-74. doi: 10.1016/j.jagp.2013.12.174. Epub 2014 Jan 4.
PubMed 24495406
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trazodone for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomised, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01142258
- Acronym / sponsor ID
- TZD-001
- Conditions
- Sleep, Sleep Disorders, Insomnia, Alzheimer's Disease
- Keywords
- Sleep Disturbances, Alzheimer disease, Insomnia, Trazodone, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Collaborators
- Universidade Federal do Paraná
- Study start
- Mar 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Jun 2010 (estimated)
- 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 trazodone is effective 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. Trazodone is commonly prescribed drugs for SD in AD patients. There are no controlled studies in this sample of patients for this purpose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trazodone | Experimental | Drug: TrazodoneStudy group will receive trazodone 50mg |
| Placebo | Placebo comparator | Drug: PlaceboInert pill |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Fifty-five years of age or older;
- Diagnosis of probable Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke/the Alzheimer's Disease and Related Disorders Association criteria;
- Hachinski Ischemia Scale score less than 5
- Mini-Mental State Examination score of O 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 medications 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 |
|---|---|---|
| TrazodoneTrazodone tablets, 50 mg, 10pm (before bedtime) for 14 days. | Drug | Trazodone |
| PlaceboInactive or inert pill which will be used as a comparator | Drug | Placebo |
Primary outcome
Change from Baseline in Nighttime Total Sleep Time
Time frame: Baseline, 14 days follow-up
10 secondary outcomes
Change from Baseline in Nighttime Wake After Sleep Onset
Time frame: Baseline, 14 days follow-up
Change from Baseline in Nighttime Number Of Awakenings
Time frame: Baseline, 14 days follow-up
Change from Baseline in Daytime Total Sleep Time
Time frame: Baseline, 14 days follow-up
Change from Baseline in Number of Daytime Naps
Time frame: Baseline, 14 days follow-up
change in cognitive function (as measured by the Mini-Mental State Examination)
Time frame: Baseline, 14 days follow-up
Change in activities of daily living (The index of ADL - Katz)
Time frame: Baseline, 14 days follow-up
Change of baseline in behavioral variables (BAHAVE-AD scale)
Time frame: Baseline, 14 days follow-up
Proportion of subjects who gained at least 30 minutes in total nighttime sleep
Time frame: Baseline, 14 days follow-up
Change from Baseline in Clinical Dementia Rating
Time frame: Baseline, 14 days follow-up
Change from Baseline in cognitive function (Digit Symbol Substitution Test)
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 15 Oct 2012.
- Derived from this study: PubMed 33189083McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
- Derived from this study: PubMed 24495406Camargos EF, Louzada LL, Quintas JL, Naves JO, Louzada FM, Nobrega OT. Trazodone improves sleep parameters in Alzheimer disease patients: a randomized, double-blind, and placebo-controlled study. Am J Geriatr Psychiatry. 2014 Dec;22(12):1565-74. doi: 10.1016/j.jagp.2013.12.174. Epub 2014 Jan 4.
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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.
Einstein F Camargos, MD, MsC principal investigator
Brasilia University - Brasilia's University Hospital - Geriatric Medical Centre
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 Trazodone 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 15 Oct 2012. 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?
Change from Baseline in 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 NCT01142258, which also lists 2 linked publications.
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 15 Oct 2012.