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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT06364228
Eligibility Criteria:
Inclusion Criteria:
* Females 50 years of age or older
* Currently an unpaid family caregiver to an older adult (50 years and older) with dementia for at least five hours a week for at least six months
* Normal or corrected to normal vision and hearing
* Mobility to travel to University of Nebraska Medical Center (UNMC) for study procedures including brain imaging
* Right-handed
* Capacity to read and write English
Exclusion Criteria:
* Major medical illness that contraindicates oxytocin (OXT) administration (e.g., severe liver disease, seizure disorder, metabolic disorder)
* History of allergic reaction to oxytocin (OXT) and its nasal spray product
* History of central nervous system (CNS) disease, including history of seizure, epilepsy, CNS tumor, CNS hemorrhage, or serious CNS infection including meningitis or encephalitis
* Currently pregnant or planning to become pregnant during the course of the study
* Metal in the body (i.e., hearing aid, cardiac pacemaker, bone plates, braces, non-removable piercing/implants, etc.), claustrophobia, or any other condition that would preclude magnetic resonance imaging (MRI) scanning
* Mini-mental status exam score of 25 or lower which suggests possible cognitive issues
* History of or current neurological disease (e.g., stroke, traumatic brain injury, brain tumor, dementia)
* History of or current severe psychiatric disease (e.g., schizophrenia, bipolar disorder, autism, severe post-traumatic stress disorder)
* History of, or current drug or alcohol abuse
* Currently breastfeeding
* Current coronavirus disease-19 (COVID-19) illness
* Left-handed due to brain structural difference between right and left-handed individuals
* Currently taking antipsychotic medications, selective serotonin reuptake inhibitors (SSRIs) or corticosteroid creams/pills
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT06364228
Study Brief:
Protocol Section:
NCT06364228