Mild Cognitive ImpairmentPhase 4NCT05209035
Evaluation of Trazodone in OSA-MCI
A Phase 4 study testing Trazodone in people with Mild Cognitive Impairment and Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Alzheimer's disease (AD) is a progressive and multifactorial neurodegenerative disease. Before progressing to AD, individuals may experience mild cognitive impairment (MCI). While these individuals with MCI have an increased risk of progressing to AD, emerging studies reveal that obstructive sleep apnea (OSA) is a… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Obstructive Sleep Apnea
- What is being tested?
- Trazodone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 May 2022to 28 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to swallow trazodone capsules
- Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening
- A diagnosis of mild cognitive impairment (MCI)
- A diagnosis of obstructive sleep apnea (OSA), and Apnea-Hypopnea Index > 5
- Neuroimaging obtained during screening consistent with a clinical diagnosis of Alzheimer's disease (AD) and without findings of significant exclusionary abnormalities
- Written informed consent to participate in the study provided by the patient
Who cannot join
- Diagnosis of dementia, neurodegenerative condition, seizure disorder or other infectious, metabolic, or systemic disease affecting the central nervous system
- Vitamin B12 or folate deficiency
- Diagnosis of mental health disorders
- Nootropic drugs except for AD prescriptions stable for at least 30 days
- Suspected or known allergy to trazodone
- Intake of drugs or substances potentially involved in clinically significant inhibition or induction of CYP34A or P-gp-medicate drug interactions with trazodone within 4 weeks or 5 half-lives of the interacting drug prior to administration of trazodone and throughout the course of the study
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- Previous exposure to anti-Aβ vaccines
- Concurrent treatment with antipsychotic agents, antiepileptics centrally active antihypertensive drugs, sedatives, opioids, mood stabilizers, or benzodiazepines within 4 weeks of screening visit
- Patients who are receiving non-benzodiazepine hypnotics
- Clinically significant, advanced, or unstable disease that might interfere with outcome evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized-Controlled Trial of Trazodone on Reducing Plasma sST2 Level and Neurodegeneration Progression in Patients With Amnestic Mild Cognitive Impairment and Obstructive Sleep Apnea
Alzheimer's disease (AD) is a progressive and multifactorial neurodegenerative disease. Before progressing to AD, individuals may experience mild cognitive impairment (MCI). While these individuals with MCI have an increased risk of progressing to AD, emerging studies reveal that obstructive sleep apnea (OSA) is a risk factor for both MCI an well as AD. Thus, it is worthwhile to identify clinical management or interventions that retard the conversion of subjects with comorbid MCI and OSA and AD.
A randomized, double-blind, placebo-controlled study proposed herein aims to examine the effect of trazodone on reducing level sST2 and protein markers that are associated with neurodegeneration in the plasma of subjects with comorbid OSA and MCI. In this 1-year study, 124 study participants will undergo a series of neurocognitive assessments.
- Conditions
- Mild Cognitive Impairment, Obstructive Sleep Apnea
- Being tested
- Trazodone, Placebo
- Medical subject headings
- Cognitive Dysfunction, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrazodoneDrug
Trazodone 50mg daily
PlaceboOther
Starch 50mg
| Study group | Role | What they receive |
|---|---|---|
| Trazodone | Active comparator | Not described Receives: Drug: Trazodone |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sST2
The change of plasma sST2 levels
Measured: Baseline, Week 4, 13, 26 and 52
Clinical Dementia Rating Score
The change in Clinical Dementia Rating global score
Measured: Baseline, Week 26 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start10 May 2022
- Primary completion2 May 2025
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong University of Science and Technology
- Responsible party
- Principal investigator, Timothy Kwok, Chinese University of Hong Kong
- Investigators
- Timothy CY Kwok, Principal investigator, Chinese University of Hong KongSusanna Ng, Principal investigator, Chinese University of Hong KongNancy Ip, Principal investigator, The Hong Kong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209035
- Sponsor's protocol ID
- 2021.038
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-Controlled Trial of Trazodone on Reducing Plasma sST2 Level and Neurodegeneration Progression in Patients With Amnestic Mild Cognitive Impairment and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05209035
- Acronym / sponsor ID
- 2021.038
- Conditions
- Mild Cognitive Impairment, Obstructive Sleep Apnea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong University of Science and Technology
- Study start
- 10 May 2022 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 26 Jan 2022 (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.
Alzheimer's disease (AD) is a progressive and multifactorial neurodegenerative disease. Before progressing to AD, individuals may experience mild cognitive impairment (MCI). While these individuals with MCI have an increased risk of progressing to AD, emerging studies reveal that obstructive sleep apnea (OSA) is a risk factor for both MCI an well as AD. Thus, it is worthwhile to identify clinical management or interventions that retard the conversion of subjects with comorbid MCI and OSA and AD.
A randomized, double-blind, placebo-controlled study proposed herein aims to examine the effect of trazodone on reducing level sST2 and protein markers that are associated with neurodegeneration in the plasma of subjects with comorbid OSA and MCI. In this 1-year study, 124 study participants will undergo a series of neurocognitive assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trazodone | Active comparator | Drug: Trazodone |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to swallow trazodone capsules
- Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening
- A diagnosis of mild cognitive impairment (MCI)
- A diagnosis of obstructive sleep apnea (OSA), and Apnea-Hypopnea Index > 5
- Neuroimaging obtained during screening consistent with a clinical diagnosis of Alzheimer's disease (AD) and without findings of significant exclusionary abnormalities
Key exclusion criteria (10 listed)
- Diagnosis of dementia, neurodegenerative condition, seizure disorder or other infectious, metabolic, or systemic disease affecting the central nervous system
- Vitamin B12 or folate deficiency
- Diagnosis of mental health disorders
- Nootropic drugs except for AD prescriptions stable for at least 30 days
- Suspected or known allergy to trazodone
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 50mg daily | Drug | Trazodone |
| PlaceboStarch 50mg | Other | Placebo |
Primary outcome
sST2
Time frame: Baseline, Week 4, 13, 26 and 52
The change of plasma sST2 levels
Clinical Dementia Rating Score
Time frame: Baseline, Week 26 and 52
The change in Clinical Dementia Rating global score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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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.
Timothy CY Kwok principal investigator
Chinese University of Hong Kong
Susanna Ng principal investigator
Chinese University of Hong Kong
Nancy Ip principal investigator
The Hong Kong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trazodone in people with Mild Cognitive Impairment and Obstructive Sleep Apnea, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. 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 Hong Kong. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
sST2 (time frame: Baseline, Week 4, 13, 26 and 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.