RecruitingPhase 2NCT06364228

Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia


Sponsor

University of Nebraska

Enrollment

32 participants

Start Date

Jun 20, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Functional MRI, a drug called Oxytocin Intranasal Spray 12 International Unit (12IU), and others for people with stress. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

Placebo intranasal spray liquid with no oxytocin will be delivered in 2 puffs to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).

DRUGOxytocin Intranasal Spray 12 International Unit (12IU)

Participants weighing less than 40 kg (88 pounds) will receive 12 IU of oxytocin delivered as 1 puff (6 IU) to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).

DRUGOxytocin Intranasal Spray 24 International Unit (24IU)

Participants weighing more than 40 kg (880 pounds) will receive 24 IU of oxytocin delivered as 2 puffs (12 IU) to each nostril daily for 21 days. The first single dose will be administered at the clinic (Visit 1).

PROCEDUREFunctional MRI

Functional MRI (fMRI) scan with affective Stroop and Empathy and Theory of Mind task (EmpaTom task will administered pre- and post-administration of oxytocin.


Locations(1)

University of Nebraska Medical Center, Department of Psychiatry

Omaha, Nebraska, United States

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NCT06364228


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