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临床试验/NCT07306065
NCT07306065已完成不适用

Scientific Proof of Music Therapy's Impact on Alzheimer's Disease

University of Central Florida1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Effect of music therapy in Alzheimer's patients by analyzing salivary exosomes

研究概览

简要总结

The purpose of this study is to scientifically validate the impact of music therapy on Alzheimer's disease (AD) by analyzing molecular biomarkers in salivary exosomes. Exosomes are extracellular vesicles that carry molecular signals from brain cells, providing a non-invasive method to assess physiological changes.

详细描述

Music therapy has long been recognized as a beneficial intervention for individuals with Alzheimer's disease (AD), with evidence supporting improvements in mood, cognitive function, and behavioral symptoms. However, despite widespread clinical use, the biological mechanisms underlying these benefits remain poorly understood. Most studies on music therapy in AD have relied on behavioral observations and qualitative assessments, lacking objective, molecular-level validation. Recent advancements in exosome research have opened new possibilities for non-invasive biomarker analysis. Exosomes, small extracellular vesicles released by cells, carry molecular signatures that reflect physiological states, including neurochemical changes associated with AD.

However, to date, no study has investigated whether music therapy induces measurable changes in exosome biomarkers related to AD pathology.

Key gaps in current knowledge include:

  1. Lack of molecular validation for music therapy: While clinical benefits have been reported, no study has demonstrated the neurochemical effects of music therapy on biomolecular markers.
  2. Unclear mechanisms of action: It remains unknown whether music therapy modulates neurotransmitter levels (serotonin, dopamine) or pathological proteins (amyloid-beta, tau) associated with AD.
  3. Absence of personalized treatment approaches: Without biomarker-based validation, music therapy is typically applied in a one-size-fits-all manner, rather than being tailored to individual neurochemical profiles.
  4. Limited non-invasive monitoring tools: Current methods for assessing treatment efficacy rely on neuroimaging or invasive procedures, which are costly and impractical for routine clinical use.

This study seeks to address these gaps by leveraging salivary exosomes as a novel, non-invasive platform to quantify molecular changes induced by music therapy in AD patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

All participants will undergo the same intervention. Each participant will be assigned a participant ID. All research data will be associated with the participant ID only and not with any of the participant's personal identifiers.

入排标准

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

入选标准

  • 50 years old or older.
  • 20 adults with no mild-cognitive impairment
  • 20 adults with mild-cognitive impairment
  • 20 adults with Alzheimer's disease/ dementia.
  • participant or the participant's legally authorized representative must be able to read or speak English and agree to comply with study procedures.
  • pregnant women may chose to participate

排除标准

  • 49 years and younger
  • prisoners
  • unable to understand English and provide consent

研究组 & 干预措施

All participants

Experimental

All participants in study will undergo music intervention.

干预措施: Music intervention (Other)

结局指标

主要结局

Effect of music therapy in Alzheimer's patients by analyzing salivary exosomes

时间窗: 6 months

To determine the effect of music therapy on key neurochemical biomarkers in Alzheimer's patients by analyzing serotonin, dopamine, amyloid-beta, and tau protein levels in salivary exosomes before and after music therapy sessions.

次要结局

  • Identifying therapeutic benefits by correlating changes in biomarkers(6 months)
  • Identify differences in individual participant biomarkers(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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