Evaluation of Trazodone in OSA-MCI

Study Overview
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Brief Summary
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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.

Official Title
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Randomized-Controlled Trial of Trazodone on Reducing Plasma sST2 Level and Neurodegeneration Progression in Patients With Amnestic Mild Cognitive Impairment and Obstructive Sleep Apnea

Conditions
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Mild Cognitive Impairment, Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Trazodone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trazodone<br> | Drug: Trazodone<br>* Trazodone 50mg daily<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Starch 50mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |