NCT06364228 Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
| NCT ID | NCT06364228 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Nebraska |
| Condition | Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-06-20 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2026-06-20 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
More than 15 million family caregivers provide support for individuals with Alzheimer's disease (AD) or related dementias. This number is expected to grow with the increasing population of persons with dementia (PWD). Stress in caregivers to older adults with chronic diseases is already a significant public health issue because it is associated with multiple negative physical and mental health outcomes for the caregiver (e.g., depression, cardiovascular disease) and can negatively impact the health of the PWD as well. Importantly, stress levels are even higher in female than male caregivers and in caregivers to PWD than other chronic conditions that affect older adults. There are numerous interventions to improve well-being in caregivers to PWD, but only two have been shown to moderately improve caregiver depression and quality of life in the PWD. However, both of the interventions are time and energy intensive. One promising candidate to reduce stress and improve quality of life is the endogenous neuropeptide oxytocin (OXT). Intranasal OXT interventions have been shown to successfully reduce stress and increase quality of life in other populations, including patients with borderline personality disorder, Post-traumatic Stress Disorder (PTSD), Anxiety Disorder, and Depressive Disorder. This study will assess the efficacy and safety of intranasal oxytocin (OXT) to improve the quality of life and reduce chronic stress levels in the caregivers to PWD. Participants will be randomly enrolled to one of three groups: 12 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo. The study drug will be administered daily for 21 days.
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
Contact & Investigator
Soonjo Hwang, MD
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT06364228 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06364228 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06364228 currently recruiting?
Yes, NCT06364228 is actively recruiting participants. Contact the research team at soonjo.hwang@unmc.edu for enrollment information.
Where is the NCT06364228 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT06364228 clinical trial?
NCT06364228 is sponsored by University of Nebraska. The principal investigator is Soonjo Hwang, MD at University of Nebraska. The trial plans to enroll 32 participants.