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临床试验/NCT05168098
NCT05168098已完成不适用

Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy

National Taiwan Normal University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
ImmunoMaggnetic-Reduction (IMR) blood tests

研究概览

简要总结

The aim of this study is to examine the effect of the olfactory stimulation intervention on the people with mild to moderate dementia. We recruit 28 participants who has been diagnosed with mild to moderate dementia from 2 day care centers in Taipei. They are randomly assigned to three groups, including the olfactory intervention group, game comparison group, and control group. Beside the control group, the participant with two other groups were required to attend twelve weeks intervention (twice a week, thirty minutes for one section). Every participants completed the olfactory test, both paper-pencil and computer-based examination for cognition, blood test and psychological measurement before and after the intervention. The results showed that the participant in olfactory intervention group significant improved score in the LOTCA-G examination, and the Aβ1-42 concentration of the blood test significant increase in the control group; furthermore, the olfactory intervention group is lowest concentration among three groups in the Tau concentration of the blood test via ANCOVA analysis.

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
Single (Participant)

入排标准

年龄范围
50 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ages >50 years with a diagnosis of mild or moderate dementia
  • being admitted to the day care center and living in the community
  • being willing to do blood test with a family member's consent.

排除标准

  • experience in chronic rhinitis or sinusitis, which causes loss of smell; inability to perform the cognitive exam or olfactory test (e.g., having a severe hearing impairment)
  • inability to attend group activities due to severe emotional or aggressive behaviors

结局指标

主要结局

ImmunoMaggnetic-Reduction (IMR) blood tests

时间窗: 60 min

A registered nurse drew 5 cc of blood from each participant twice, including pretest and posttest by the following procedure: Step 1: Plasma preparation 10-ml K3 EDTA tubes were used for collecting blood, immediately followed by gently inverting each blood tube 10 times. Blood tubes were centrifuged at room temperature at 2500g for 15 minutes with an aid of a swing-out (backet) rotor. Every 1-ml plasma (supernatant) was transferred to a fresh 1.5-ml eppendorf using a disposable 1-ml micropipette tip. All the plasma samples were frozen at -80 °C before measurements. Step 2: Assays of plasma biomarkers IMR kits were used in assaying amyloid B 1-42 and tau protein (Tau). For assaying AB1-42, 60-ul reagent was mixed with 60-ul plasma. For assaying Tau, 80-ul reagent was mixed with 40-ul plasma. Duplicated measurements were conducted for each biomarker per plasma sample. The average value of the duplicated measured concentrations is reported.

次要结局

  • Mini-mental State Examination(60 min.)
  • The Top International Biotech Smell Identification Test (TIBSIT)(60 min.)
  • Geriatric Depression Scale (GDS-15)(60 min.)
  • Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)(60 min.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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