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临床试验/NCT06783010
NCT06783010尚未招募不适用

Sviluppo di Uno Score di Rischio Multidimensionale Basato Sui Deficit Sensoriali, Con un Approccio in Ensemble Learning, Per il Deterioramento Cognitivo in Una Coorte di Anziani Dell'Italia Meridionale

Azienda Sanitaria Locale Bari0 个研究点目标入组 30 人开始时间: 2025年6月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
cognitive decline

研究概览

简要总结

There is now strong scientific literature showing a relationship between sensory loss and cognitive performance and between sensory loss and incident dementia. We take as our starting point that people with hearing, vision, and/or cognitive problems have poorer health outcomes, possibly due to due to common age-related mechanism(s), iatrogenic problems in the health care system (e.g., misdiagnosis), and/or the decay of social networks. With this evidence, our project will provide a better understanding of the relationship between sensory loss and cognitive loss in older adults with or at risk for dementia using objective technologies to measure sensory deficits that refer not only to vision loss, hearing loss, olfaction and taste but also to senses deemed atypical, i.e., nociception. In particular, the project aims:

  1. To assess the specific association between different sensory measures (central and peripheral hearing loss, retinal abnormalities measured by OCT, smell and taste objective measures, chronic pain, and proprioception subjective and electrophysiological measures.
  2. To develop a multi-dimensional score using sensory features and clinical and lifestyle variables to predict the different types of dementia (Alzheimer's Disease, Fronto-Temporal Dementia, and Vascular Dementia) at different stages (Mild Cognitive impairment and Normal Cognition).
  3. To create a connectomic map of the MRI morphologic and dynamic features of the Dementia cases and their relationships with sensorial features, describing the patterns differences in respect to the normal cognition controls.

To achieve the proposed aims, the synergic work of the four units involved in the proposal will be required. Subject assessment will be divided between clinical setting (ICS Maugeri) and population setting (ASL BARI). IRCCS "S. De Bellis" will provide expertise for both design refinement, creation and monitoring of deliverables and milestones, and technological support for sense measurements. Finally, the features extracted in clinical populations afferent to the centers of the Azienda Sanitaria Locale di Bari and the neurological clinics of the ICS Maugeri will be analyzed with innovative methods by the Polytechnic University of Bari using artificial intelligence algorithms based on ensemble learning for the creation of a predictive score for cognitive impairment that takes into account both sensory and clinical aspects and related to lifestyles.

详细描述

Background / State of the art Hearing, Vision, Olfaction, and Taste represent a complex sensory neural construct biologically linked to age (Gadkaree et al., 2016). Several studies have described their role as predictors in age-related neurodegenerative processes, particularly those related to cognitive decline (Brenowitz et al., 2020; Schubert et al., 2017). Hearing and vision are the most explored, providing robust population-based evidence (Gates et al., 2010; Panza et al., 2019; Sardone, Battista, et al., 2020) and using groundbreaking technologies, such as retinal imaging, in specific clinical settings for the latter. In its peripheral and central forms, hearing impairment has been considered one of the major modifiable risk factors for Alzheimer's dementia(Livingston et al., 2020). Among the sensory inputs related to the perception of physical events in the body, nociception and proprioception represent a set of functions that are often underestimated in their cognitive processing. Studies have shown how they are important not only in the global function of the elderly individual but also and especially in cognitive function. The interactions between aging processes and nociception are poorly investigated, particularly the relationship between chronic pain and global cognitive functions (Nadar et al., 2016). In particular, there are no precise correlates between different objective cognitive function analysis technologies, such as MRI and single or multiple interactions from sensory impairment.

Description and distribution of activities of each operating unit

Principal collaborators will have divided but integrated roles for the aims of the project. In particular, we can highlight two main branches of activities, with a list of the main activities for each research center:

  1. Study Role: clinical and instrumental assessment
  • ASL BA - Controls enrollment and cognitive-behavioural assessment research expertise
  • Scientific Clinical Institutes Maugeri (ICS-Maugeri): Cases enrollment and functional and somato-sensorial research expertise
  1. Study Role: design, modelling and feature elaboration

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

cognitive decline

时间窗: 36 months

every subject from MOCA 15.5-26 to a MOCA score lower than 15.5

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Panza

MD

Azienda Sanitaria Locale Bari

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