Evaluation of Trazodone in OSA-MCI

Phase 4

Active, not recruiting

• Conditions: Obstructive Sleep Apnea; Mild Cognitive Impairment
• Interventions: Other: Placebo; Drug: Trazodone

• Registration Number: NCT05209035
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-26
• Study Start: 2022-05-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-05-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Trazodone	Trazodone	-

Primary Outcome Measures

Name	Time	Method
sST2	Baseline, Week 4, 13, 26 and 52	The change of plasma sST2 levels
Clinical Dementia Rating Score	Baseline, Week 26 and 52	The change in Clinical Dementia Rating global score

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong