Evaluation of Trazodone in OSA-MCI

The Chinese University of Hong Kong

Status and phase

Active, not recruiting

Phase 4

Conditions

Mild Cognitive Impairment

Obstructive Sleep Apnea

Treatments

Drug: Trazodone

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05209035

2021.038

Details and patient eligibility

About

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.

Enrollment

134 estimated patients

Sex

All

Ages

60 to 80 years old

Volunteers

Accepts Healthy Volunteers

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