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Evaluation of Trazodone in OSA-MCI | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE4

Evaluation of Trazodone in OSA-MCI

Randomized-Controlled Trial of Trazodone on Reducing Plasma sST2 Level and Neurodegeneration Progression in Patients With Amnestic Mild Cognitive Impairment and Obstructive Sleep Apnea

NCT05209035•Chinese University of Hong Kong

View on ClinicalTrials.gov

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 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.

Eligibility

Age

60 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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
•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

Locations (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Key Dates

Start Date

May 10, 2022

Primary Completion Date

May 2, 2025

Completion Date

February 28, 2026

Last Updated

January 6, 2026

Enrollment

134

ESTIMATED participants

Conditions

Mild Cognitive ImpairmentObstructive Sleep Apnea

Interventions

Trazodone

DRUG

Placebo

OTHER

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NCT06430957

Obstructive Sleep Apnea Risk ManagementPostoperative Complications+2 more

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RECRUITINGPHASE1/PHASE2

Sense4Safety Intervention

NCT07220668

Mild Cognitive Impairment

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Trazodone in OSA-MCI

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Sense4Safety Intervention

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