Clinical trial NCT05209035: Evaluation of Trazodone in OSA-MCI
Official title: Randomized-Controlled Trial of Trazodone on Reducing Plasma sST2 Level and Neurodegeneration Progression in Patients With Amnestic Mild Cognitive Impairment and Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Mild Cognitive Impairment
Obstructive Sleep Apnea
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong University of Science and Technology
First posted: 2022-01-26
Enrollment: 134
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: sST2
timeFrame: Baseline, Week 4, 13, 26 and 52
measure: Clinical Dementia Rating Score
timeFrame: Baseline, Week 26 and 52
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Timothy CY Kwok
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Susanna Ng
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hong Kong University of Science and Technology
name: Nancy Ip
role: PRINCIPAL_INVESTIGATOR
References: