Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

April 30, 2026 updated by: University of Nebraska

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 a PWD than other chronic conditions that affect older adults. 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. However, currently there is no comprehensive study examining its role in the caregivers to chronic medical/psychiatric illnesses including dementia for potential beneficial impact as well as reducing chronic stress levels.

Eligible females who are family caregivers to a PWD for a least five hours a week for six consecutive months 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. Surveys and questionnaires that evaluate mental and emotional health and functional magnetic resonance imaging (fMRI) will be administered before and after the study treatment to see if oxytocin will help improve quality of life better and lower stress levels in caregivers to people who have dementia. Additionally, the study will find out if the brain responds to oxytocin.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Minjoo Kang, MEd
  • Phone Number: 402-552-6239
  • Email: mkang@unmc.edu

Study Contact Backup

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 61898-5581
        • Recruiting
        • University of Nebraska Medical Center, Department of Psychiatry
        • Principal Investigator:
          • Soonjo Hwang, MD
        • Sub-Investigator:
          • Janelle N Beadle, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Intranasal Spray Placebo
Nasal spray of placebo liquid solution is administered as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan will be done pre- and post-administration.
Drug: Placebo
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).
Procedure: Functional 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.
Other Names:
  • fMRI
Active Comparator: Oxytocin Intranasal Spray 12 International Units
Nasal spray of Oxytocin 12 International Units (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration.
Procedure: Functional 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.
Other Names:
  • fMRI
Drug: Oxytocin 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).
Other Names:
  • Oxytocin 12IU
Active Comparator: Oxytocin Intranasal Spray 24 International Units
Nasal spray of Oxytocin 24 International Units (24IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. Functional magnetic resonance imaging (fMRI) scan pre- and post-administration.
Procedure: Functional 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.
Other Names:
  • fMRI
Drug: Oxytocin 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).
Other Names:
  • Oxytocin 24IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Stress Level in the Past Thirty Days
Time Frame: Baseline (Visit 1) and Post-intervention (Visit 2)
Participant's chronic ctress levels in the past thirty Days will be assessed by the Perceived Stress Scale (PSS) which asks ten questions about participant stress within the last 30 days. The questions are scored from 0 ("never") to 4 ("very often) with specific items needing to be reverse scored. Higher scores indicate higher levels of perceived stress (a worse outcome). The instrument takes about 5 minutes to complete.
Baseline (Visit 1) and Post-intervention (Visit 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Quality of Life
Time Frame: Baseline (Visit 1) and Post-intervention (Visit 2)
Participant quality of life will be assessed by the Health Organization Quality of Life- Short version (WHO-QOL-BREF) survey which measures general perceptions about quality of life in four aspects: physical health, psychological health, social relationships, and environment. The aspects are scored from 1 ('very poor') to 5 ('very good'). Aspect scores are totaled with higher scores indicating a better outcome. The instrument takes about 15 minutes to complete.
Baseline (Visit 1) and Post-intervention (Visit 2)
Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and Empathy and Theory of Mind(EmpaToM) task
Time Frame: Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 60 minutes to complete at each time point.
Neural level changes will be measured by Functional Magnetic Resonance Imaging (fMRI).
Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 60 minutes to complete at each time point.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Orientation Screening
Time Frame: Visit 1 (Baseline visit). It will take about 10 minutes.
Participants will complete a brief cognitive orientation screening tool, called the Mini-Mental Status Exam. This will be administered by the research assistant. If the participant scores below 26 on this measure, they will be excluded from the study, as it may indicate potential cognitive issues. The scale ranges from 0 to 30, with higher scores indicating better cognitive performance (better outcomes).
Visit 1 (Baseline visit). It will take about 10 minutes.
Geriatric Anxiety Scale (GAS-10)
Time Frame: Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 5 minutes to complete at each time point.
Geriatric Anxiety Scale (GAS-10) will assess 10 Items. The rating scale ranges from 0 to 30 points. Higher scores indicate more severe anxiety (worse outcomes).
Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 5 minutes to complete at each time point.
Geriatric Depression Scale Short Form (GDS-SF)
Time Frame: Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 7 minutes to complete at each time point.
Geriatric Depression Scale Short Form (GDS-SF) is a rating scale from 0 to 15 points. Higher scores indicate more likelihood of depression symptoms and need for further assessment of depression (worse outcomes).
Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 7 minutes to complete at each time point.
Alcohol Use Disorders Identification Test
Time Frame: Baseline (Visit 1) and Post-intervention (Visit 2)
The Alcohol Use Disorders Identification Test (AUDIT Alcohol Screening Tool) assesses 10 items about alcohol consumption, drinking behaviors, and alcohol-related problems of the caregiver. Total scores range from 0 to 40. Higher scores indicate a greater likelihood of harmful alcohol consumption (worse outcomes). Caregivers will complete the instrument twice, each time taking about 10 minutes to finish.
Baseline (Visit 1) and Post-intervention (Visit 2)
Neuropsychiatric Inventory-Questionnaire
Time Frame: Baseline (Visit 1) and Post-intervention (Visit 2)
The Neuropsychiatric Inventory-Questionnaire (NPI-Q) measures 12 domains. The caregiver selects present or absent for symptoms in each domain of the individual with dementia, then rates the severity of symptoms present in the past month. Each domain is scored from 0 to 3 and all domain scores are totaled. Higher scores indicating more severe symptoms (worse outcomes). This instrument also rates impact of the symptoms of individual with dementia on the caregiver (Distress) in each domain. The Distress of each domain is scored from 0 to 5 and all domain scores are totaled. Higher scores indicating more extreme levels of distress (worse outcomes). Caregivers will complete the instrument twice, each time taking about 5 minutes to finish.
Baseline (Visit 1) and Post-intervention (Visit 2)
Quick Dementia Rating Scale
Time Frame: Baseline (Visit 1) and Post-intervention (Visit 2)
The Quick Dementia Rating Scale (QDRS) measures 10 different domains of daily functioning, mood, and behavior. Caregivers rate the severity of dementia symptoms in each domain about the individual for whom they are providing care. Total scores range from 0 to 30, with higher scores indicating more impairment (worse outcomes). Caregivers will complete the instrument twice, each time taking about 5 minutes to finish.
Baseline (Visit 1) and Post-intervention (Visit 2)
The Interpersonal Reactivity Index
Time Frame: Baseline (Visit 1) and Post-intervention (Visit 2)
The Interpersonal Reactivity Index (IRI) is a multidimensional measure of empathy of the caregiver. This instrument has four subscales: Perspective Taking, Empathic Concern, Personal Distress, and Fantasy. Each subscale has 7 items scored from 0 to 4 with specific items needing to be reverse scored. Higher scores indicate greater empathy (better outcomes). Caregivers will complete the instrument twice, each time taking about 10 minutes to finish.
Baseline (Visit 1) and Post-intervention (Visit 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Soonjo Hwang, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0133-24-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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