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Evaluation of Trazodone in OSA-MCI

The Chinese University of Hong Kong logo

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

134 participants in 2 patient groups, including a placebo group

Trazodone
Active Comparator group
Treatment:
Drug: Trazodone
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Timothy Kwok; Hazel Mok

Data sourced from clinicaltrials.gov

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