Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

Launched by UNIVERSITY OF NEBRASKA · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a nasal spray containing oxytocin, a hormone often called the "love hormone," can help female caregivers who take care of older adults with dementia. The researchers want to see if this treatment can improve the caregivers' quality of life and lower their stress levels. The study will involve women aged 50 and older who have been caring for someone with dementia for at least five hours a week for the past six months. Participants will receive either the oxytocin spray or a placebo (a non-active treatment) once a day for three weeks.

To join the study, eligible women must be right-handed, able to travel to a medical center for tests, and able to read and write in English. Certain health conditions, like severe medical issues or a history of specific neurological or psychiatric disorders, may prevent someone from participating. It's important to note that the trial is not yet recruiting participants, so those interested will need to wait for it to begin. Overall, this research aims to provide valuable insights into supporting caregivers who often face high levels of stress while caring for loved ones with dementia.

Gender

FEMALE

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