Evaluation of Trazodone in OSA-MCI

Phase 4

Active, not recruiting

• Conditions: Mild Cognitive Impairment; Obstructive Sleep Apnea

• Registration Number: NCT05209035
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-1-13
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Able to swallow trazodone capsules<br><br> - Stable pharmacological treatment of any other chronic conditions for at least 30<br> days prior to screening<br><br> - A diagnosis of mild cognitive impairment (MCI)<br><br> - A diagnosis of obstructive sleep apnea (OSA), and Apnea-Hypopnea Index > 5<br><br> - Neuroimaging obtained during screening consistent with a clinical diagnosis of<br> Alzheimer's disease (AD) and without findings of significant exclusionary<br> abnormalities<br><br> - Written informed consent to participate in the study provided by the patient<br><br>Exclusion Criteria:<br><br> - Diagnosis of dementia, neurodegenerative condition, seizure disorder or other<br> infectious, metabolic, or systemic disease affecting the central nervous system<br><br> - Vitamin B12 or folate deficiency<br><br> - Diagnosis of mental health disorders<br><br> - Nootropic drugs except for AD prescriptions stable for at least 30 days<br><br> - Suspected or known allergy to trazodone<br><br> - Intake of drugs or substances potentially involved in clinically significant<br> inhibition or induction of CYP34A or P-gp-medicate drug interactions with trazodone<br> within 4 weeks or 5 half-lives of the interacting drug prior to administration of<br> trazodone and throughout the course of the study<br><br> - Previous exposure to anti-Aß vaccines<br><br> - Concurrent treatment with antipsychotic agents, antiepileptics centrally active<br> antihypertensive drugs, sedatives, opioids, mood stabilizers, or benzodiazepines<br> within 4 weeks of screening visit<br><br> - Patients who are receiving non-benzodiazepine hypnotics<br><br> - Clinically significant, advanced, or unstable disease that might interfere with<br> outcome evaluations

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sST2;Clinical Dementia Rating Score