Evaluation of Trazodone in OSA-MCI

NCT05209035 | Active Not Recruiting Phase 4

• 1 other identifier: 2021.038
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Trazodone

ACTIVE COMPARATOR

Drug: Trazodone

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Trazodone DRUG

Trazodone 50mg daily

Trazodone

Placebo OTHER

Starch 50mg

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Written informed consent to participate in the study provided by the patient

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Hong Kong University of Science and Technology: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Sleep Apnea, Obstructive

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Officials

• Timothy CY Kwok

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Susanna Ng

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Nancy Ip

  The Hong Kong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 26, 2022
• Study Start: May 10, 2022
• Primary Completion: May 2, 2025
• Study Completion: February 28, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

HK (1)