Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

The registry classes the interventions as drug and procedure.

More on the Plan

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.

Additionally, the study will find out if the brain responds to oxytocin.

Who Took Part

The registry lists 32 planned participants were the target.

It was open to women only aged from 50 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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. Capacity to read and write English.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2026-06-20 with completion listed for 2027-05.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Chronic Stress Level in the Past Thirty Days (time frame: Baseline (Visit 1) and Post-intervention (Visit 2)).

It also tracked 2 secondary outcomes, for example Participant Quality of Life.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 32 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.