Oxytocin Aging Study

NCT02069431 | Terminated Phase 1 FDA Drug

• 5 other identifiers: IRB201300801-NAG028740P30AG028740F016327AGR DTD 09-01-2016
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 2

Brief Summary

The life expectancy of older Americans continues to increase, with persons aged \> 65 years representing the fastest growing segment of the US population (Manton et al., 1995). While prolongation of life remains an important public health goal, a goal of even greater significance is that extended life should involve preservation of the capacity to live independently and to function well physically, cognitively, and socioemotionally (Katz et al., 1983). Therefore, identification of proven interventions to maintaining functioning across these domains and prevent disability is a major public health challenge (Branch et al., 1991). Greater physical and cognitive independence in older adults has been shown to crucially influence social integration in old age (Cornwell \& Waite, 2009), resulting in significant increase in quality of life and reduction of risk for morbidity and mortality, social stress, anxiety, and depressive symptoms (Bassuk et al., 1999; Seeman, 1996). A promising candidate to promote functional levels across physical, cognitive, and socioemotional domains is the neuropeptide oxytocin (OT) (Barraza et al., 2013; Bartz et al., 2011; Feifel et al., 2012; Meyer-Lindenberg et al., 2011; Szeto et al., 2012). Combining neuroendocrine with behavioral approaches (e.g., performance-based measures of physical and cognitive function), the proposed multidisciplinary research therefore sets out to clarify the extent to which intranasal administration of OT over a period of 4 weeks can reduce inflammation and improve physical and cognitive function in older men. Constituting a complementary piece to the IRB approved currently ongoing Faces Study (IRB # 39-2013), this project will also allow examination of interactions between OT's effect on physical health, cognition, and socioemotional function.

Conditions

Inflammation

Keywords

inflammation; physical function; cognitive function

Outcome Measures

Primary Outcomes (1)

• The use of intranasal oxytocin (OT) will reduce inflammatory biomarkers in older men and women after the 4 week treatment (post intervention).

  The use of intranasal OT will reduce inflammatory biomarkers (IL-6, tumor necrosis factor (TNF)-α, TNF-sR1, TNF-sR2, CRP) measured in blood samples.

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Secondary Outcomes (2)

• The use of intranasal OT will improve objective and subjective physical function (gait, balance, fatigue, etc.) in older men and women after the 4 week treatment (post intervention).

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• The use of intranasal OT will improve socioemotional function (face processing, emotion processing, etc.) in older men and women after the 4 week treatment (post intervention).

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Other Outcomes (1)

• The use of intranasal OT will improve auditory and cognitive function (executive functioning, attention, memory, etc.) in older men and women after the 4 week treatment (post intervention).

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Study Arms (2)

Intranasal Oxytocin spray

EXPERIMENTAL

Intranasal OT (24 IUs) self-administration will take place twice a day over a 28-day period.

Drug: Intranasal Oxytocin spray

Intranasal Placebo spray

PLACEBO COMPARATOR

placebo (containing all of the inert ingredients except for the oxytocin) self-administration will take place twice a day over a 28-day period.

Other: Intranasal Placebo spray

Interventions

Intranasal Oxytocin spray DRUG

Intranasal OT (24 IUs) self-administration will take place twice a day over a 28-day period.

Intranasal Oxytocin spray

Intranasal Placebo spray OTHER

placebo (containing all of the inert ingredients except for the oxytocin) self-administration will take place twice a day over a 28-day period.

Intranasal Placebo spray

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males and females aged 55 years or older
• generally healthy physically and cognitively
• blood pressure \< 180/100 mm Hg
• willing and able to give informed consent.

You may not qualify if:

• participants will be extensively screened for study eligibility aligning with study and safety requirements related to drug application and Magnetic Resonance Imaging (MRI)/Magnetic Resonance Spectroscopy (MRS)

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Clinical Research Center

Gainesville, Florida, 32611, United States

Location

UF Institute on Aging Clinical and Translational Research Building

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Natlie Ebner, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 24, 2014
• Study Start: February 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

US (2)