Evaluation of Trazodone in OSA-MCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2026-02-28

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.

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Detailed Description

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Conditions

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Mild Cognitive Impairment Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Trazodone

Group Type ACTIVE_COMPARATOR

Trazodone

Intervention Type DRUG

Trazodone 50mg daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Starch 50mg

Interventions

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Trazodone

Trazodone 50mg daily

Intervention Type DRUG

Placebo

Starch 50mg

Intervention Type OTHER

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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes