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

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 Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea; Mild Cognitive Impairment
• Intervention / Treatment: Drug: Trazodone; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Starch 50mg
Active Comparator: Trazodone	Drug: Trazodone; Trazodone 50mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sST2	The change of plasma sST2 levels	Baseline, Week 4, 13, 26 and 52
Clinical Dementia Rating Score	The change in Clinical Dementia Rating global score	Baseline, Week 26 and 52

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Hong Kong University of Science and Technology
• Investigators: Principal Investigator: Susanna Ng, Chinese University of Hong Kong; Principal Investigator: Timothy CY Kwok, Chinese University of Hong Kong; Principal Investigator: Nancy Ip, The Hong Kong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): May 2, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Estimated): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Respiratory Tract Diseases; Neurocognitive Disorders; Respiration Disorders; Cognition Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Cognitive Dysfunction; Sleep Apnea, Obstructive; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Pyridones; Trazodone
• Other Study ID Numbers: 2021.038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No