NCT05209035

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mild Cognitive Impairment
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Trazodone	Trazodone 50mg daily
OTHER	Placebo	Starch 50mg

Timeline

• Start date: 2022-05-10
• Primary completion: 2025-05-02
• Completion: 2026-02-28
• First posted: 2022-01-26
• Last updated: 2026-01-06

Locations

1 site across 1 country: Hong Kong