Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT05209035
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT05209035
Study Brief:
Protocol Section:
NCT05209035