Status:
ACTIVE_NOT_RECRUITING
Evaluation of Trazodone in OSA-MCI
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Hong Kong University of Science and Technology
Conditions:
Mild Cognitive Impairment
Obstructive Sleep Apnea
Eligibility:
All Genders
60-80 years
Phase:
PHASE4
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT05209035
Start Date
May 10 2022
End Date
February 28 2026
Last Update
January 6 2026
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong