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New treatment option for Stress
Official title Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
ClinicalTrials.gov ID: NCT06364228
What this study is testing
What is Oxytocin Intranasal Spray 12 International Unit (12IU)?
Oxytocin Intranasal Spray 12 International Unit (12IU) is an investigational medicine, given as an once-daily, being studied as a potential treatment for stress.
Also referred to as Oxytocin 12IU.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, women only. Healthy volunteers may be eligible.
You may be able to join 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
You likely can't join 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...
- 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...
- Mini-mental status exam score of 25 or lower which suggests possible cognitive issues
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Omaha, Nebraska, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.