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临床试验/NCT02069431
NCT02069431终止1 期

Effects of Oxytocin on Physical and Cognitive Functioning in the Elders

University of Florida2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
153
试验地点
2
主要终点
The use of intranasal oxytocin (OT) will reduce inflammatory biomarkers in older men and women after the 4 week treatment (post intervention).

研究概览

简要总结

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.

详细描述

Overview:

  • Initial screening visit
  • 3 baseline study visits
  • 4-week treatment phase
  • 3 study visits after treatment
  • Follow-up phone contact

All study visits will be conducted at the Institute on Aging or the McKnight Brain Institute at the University of Florida. The treatment phase will take place in the participant's home.

The participant will be assigned by chance to receive either the oxytocin or the placebo. The placebo is a substance, like salt water, that looks like and is given in the same way as the oxytocin but contains no oxytocin. Neither the participant nor the research assistant will know which type of dose they are getting. This information is coded and securely stored away until the data is analyzed, but that information is available if it is needed.

Screening Visit: Together with the information obtained in the phone pre-screening that the investigators have already conducted, the main purpose of the screening visit is to find out if the participant is eligible to participate in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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)

研究组 & 干预措施

Intranasal Oxytocin spray

Experimental

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

干预措施: Intranasal Oxytocin spray (Drug)

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.

干预措施: Intranasal Placebo spray (Other)

结局指标

主要结局

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

时间窗: Day 28

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.

次要结局

  • 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).(Day 28)
  • 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).(Day 28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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