Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia

ConditionStress
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Placebo
  • Oxytocin Intranasal Spray 12 International Unit (12IU)
  • Oxytocin Intranasal Spray 24 International Unit (24IU)
  • Functional MRI

Treatment groups

32 Participants
are divided into 3 treatment groups

Sponsors and collaborators