Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

NCT06364228 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 0133-24-FB
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Keywords

Oxytocin; Stress level; Caregivers; Dementia; fMRI; Neuroimaging; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Chronic Stress Level in the Past Thirty Days

  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 Outcomes (2)

• Participant Quality of Life

  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

  Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 60 minutes to complete at each time point.

Other Outcomes (7)

• Cognitive Orientation Screening

  Visit 1 (Baseline visit). It will take about 10 minutes.

• Geriatric Anxiety Scale (GAS-10)

  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)

  Baseline (Visit 1) and Post-intervention (Visit 2) It will take about 7 minutes to complete at each time point.

Study Arms (3)

Intranasal Spray Placebo

PLACEBO COMPARATOR

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; Procedure: Functional MRI

Oxytocin Intranasal Spray 12 International Units

ACTIVE COMPARATOR

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.

Drug: Oxytocin Intranasal Spray 12 International Unit (12IU); Procedure: Functional MRI

Oxytocin Intranasal Spray 24 International Units

ACTIVE COMPARATOR

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.

Drug: Oxytocin Intranasal Spray 24 International Unit (24IU); Procedure: Functional MRI

Interventions

Placebo DRUG

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).

Intranasal Spray Placebo

Oxytocin Intranasal Spray 12 International Unit (12IU) DRUG

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).

Also known as: Oxytocin 12IU

Oxytocin Intranasal Spray 12 International Units

Oxytocin Intranasal Spray 24 International Unit (24IU) DRUG

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).

Also known as: Oxytocin 24IU

Oxytocin Intranasal Spray 24 International Units

Functional MRI PROCEDURE

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

Also known as: fMRI

Intranasal Spray Placebo; Oxytocin Intranasal Spray 12 International Units; Oxytocin Intranasal Spray 24 International Units

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, Department of Psychiatry

Omaha, Nebraska, 61898-5581, United States

RECRUITING

Related Publications (36)

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  BACKGROUND

MeSH Terms

Conditions

Dementia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Soonjo Hwang, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soonjo Hwang, MD

CONTACT

402-552-6351; soonjo.hwang@unmc.edu

Minjoo Kang, MEd

CONTACT

402-552-6239; mkang@unmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 15, 2024
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)