Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

University of Nebraska

Status and phase: Begins enrollment this month; Phase 2

Conditions: Stress

Treatments: Drug: Oxytocin Intranasal Spray 24 International Unit (24IU); Drug: Placebo; Procedure: Functional MRI; Drug: Oxytocin Intranasal Spray 12 International Unit (12IU)

Study type: Interventional

Funder types: Other

Identifiers

NCT06364228

0133-24-FB

Details and patient eligibility

About

The proposed study is a double-blind, randomized, placebo-controlled study of intranasal oxytocin (OXT) to determine its efficacy in improving quality of life and reducing stress in caregivers to persons with dementia. Planned enrollment is 32 participants over 2 years.

Full description

The overall aim of this study is to determine the efficacy and safety of intranasal oxytocin (OXT) to improve the quality of life and reduce chronic stress levels in the caregivers to the persons with dementia. Randomized, double-blind, placebo-controlled clinical trial of intranasal oxytocin (12 or 24 IU) will be conducted by daily administration (once a day) for 21 days (3 weeks).

Endogenous neuropeptide oxytocin (OXT) has been a focus of prior psychiatric research based upon its role in pro-social behavior and modulation of response to social/emotional stimuli. 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.

The current study aims to establish intranasal OXT's efficacy and safety for these clinical implications. Investigators will also apply methods (task related functional MRI) that have shown verifiable and measurable ability to capture the core target area (mPFC and amygdala) and its change in response to OXT.

This project will lead to progress in understanding the potential role of OXT on the relationship between caregiver and the person with chronic medical/psychiatric illnesses such as dementia. It will also guide future direction for clinical use of intranasal OXT for this critical population.

Enrollment: 32 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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 in English

Exclusion criteria

• Major medical illness that contraindicates oxytocin (OXT) administration (e.g., severe liver disease, seizure disorder, metabolic disorder)
• Past 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 in the next few weeks 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 our 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

32 participants in 3 patient groups, including a placebo group

Intranasal Spray Placebo

Placebo Comparator group

Description:

Nasal Spray of placebo liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. fMRI scan pre and post-administration.

Treatment:

Procedure: Functional MRI

Drug: Placebo

Oxytocin Intranasal Spray 12 International Unit (IU)

Active Comparator group

Description:

Nasal spray of Oxytocin 12 International Unit (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. fMRI scan pre and post administration.

Treatment:

Drug: Oxytocin Intranasal Spray 12 International Unit (12IU)

Procedure: Functional MRI

Oxytocin Intranasal Spray 24 International Unit (IU)

Active Comparator group

Description:

Nasal spray of Oxytocin 24 International Unit (12IU) liquid solution as 2 puffs of daily dose (every morning) for 3 weeks. fMRI scan pre and post administration.

Treatment:

Procedure: Functional MRI

Drug: Oxytocin Intranasal Spray 24 International Unit (24IU)