Back to resultsEvaluation of Trazodone in OSA-MCI
Primary Purpose
Mild Cognitive Impairment, Obstructive Sleep Apnea
Status
Recruiting
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Trazodone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
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
Sites / Locations
- The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Trazodone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
sST2
The change of plasma sST2 levels
Clinical Dementia Rating Score
The change in Clinical Dementia Rating global score
Secondary Outcome Measures
Full Information
NCT ID
NCT05209035
First Posted
January 13, 2022
Last Updated
July 18, 2022
Sponsor
Chinese University of Hong Kong
Collaborators
Hong Kong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05209035
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Hong Kong University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trazodone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Trazodone
Intervention Description
Trazodone 50mg daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Starch 50mg
Primary Outcome Measure Information:
Title
sST2
Description
The change of plasma sST2 levels
Time Frame
Baseline, Week 4, 13, 26 and 52
Title
Clinical Dementia Rating Score
Description
The change in Clinical Dementia Rating global score
Time Frame
Baseline, Week 26 and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Kwok
Phone
+852 3505 3173
Email
tkwok@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Hazel Mok
Phone
+852 3505 3990
Email
hazelmok@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy CY Kwok
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susanna Ng
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Ip
Organizational Affiliation
The Hong Kong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Kwok, MD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Trazodone in OSA-MCI
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