Evaluation of Trazodone in OSA-MCI

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