跳至主要内容
临床试验/NCT06596746
NCT06596746招募中不适用

Neurodegenerative Diseases Progression Markers (MARKERS-NDD): a Real-world Data Longitudinal Prospective Study

Casa di Cura San Raffaele Cassino2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年9月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
2
主要终点
To monitor and predict the course of neurodegenerative diseases through the study of clinical markers and the creation of AI-models

研究概览

简要总结

MARKERS-NDD is a prospective, observational, longitudinal study, which aims to collect data from patients affected by neurodegenerative diseases (NDD) followed longitudinally for routine examinations performed as part of normal clinical practice. Data collected from clinical evaluations, movement analysis, brain imaging, neuropsychological and electroencephalographic assessments, blood chemistry tests will be analysed to carry out statistical investigations and predictive analyses, also using artificial intelligence systems, which allow the identification of new early markers of diagnosis and prognosis of neurodegenerative diseases.

详细描述

Considering the current estimates and the global social and economic burden of neurodegenerative diseases, changes in the manner and timing of a diagnosis of these diseases are urgently needed as well as in the timeliness with which effective therapeutic interventions are carried out. The complexity of the molecular mechanisms underlying neuronal degeneration and the heterogeneity of the population of patients affected by neurodegenerative diseases present enormous challenges to the development of early diagnostic tools and systems capable of predicting the course of the disease.

Despite intensive research in the field of pharmacology, surgery and rehabilitation, neurodegenerative diseases remain chronic progressive diseases without a therapy that can change the course.

MARKERS-NDD is a prospective, observational, longitudinal study, which aims to collect data from patients affected by neurodegenerative diseases (NDD) followed longitudinally for routine examinations performed as part of normal clinical practice. Data collected from clinical evaluations, movement analysis, brain imaging, neuropsychological and electroencephalographic assessments, blood chemistry tests will be analysed to carry out statistical investigations and predictive analyses, also using artificial intelligence systems, which allow the identification of new early markers of diagnosis and prognosis of neurodegenerative diseases.

Quantitative movement analysis, with the aid of standard motion capture systems (gait analysis) and with wearable inertial sensors, is a valid tool both for supporting clinical diagnostics and to assess the response to pharmacological treatment, and to monitor the progression of NDDs. From this perspective, the kinematic analysis of gait and graphic gesture can reveal early alterations of motor features to support the differential diagnosis and stratification of the patient and allow us to follow the progression of the disease over time.

Although motor symptoms represent key aspects for differential diagnosis between parkinsonian syndrome and dementia, alterations of cognitive functions, and in particular, of executive functions can be also present in the early stages of the disease in patients with synucleinopathies such as PD and Lewy Body Dementia.

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
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with diagnosis of Parkinson's Disease, Parkinsonism and Movement Disorders
  • Patients with diagnosis of Parkinson's Disease
  • Diagnosis of Parkinson's Disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank
  • Diagnosis of Movement Disorder not related to Parkinson's Disease
  • Diagnosis of Multiple System Atrophy (MSA) in accordance with Second Consensus Statement on Diagnosis of Multiple System Atrophy;
  • Diagnosis of Progressive Supranuclear Palsy according to Movement Disorder Society for Diagnosis of Progressive Supranuclear Palsy;
  • Diagnosis of Essential Tremor
  • Willing to participate in the study, understand the procedures and sign the informed consent.
  • Patients affected by cognitive impairment (CI) and dementia
  • Diagnosis of probable:
  • Lewy Body Dementia
  • Alzheimer's Disease
  • Mild Cognitive Decline
  • Subjective memory complaints
  • Willing to participate in the study, understand the procedures and sign the informed consent.

排除标准

  • There are no restrictions for participation in the study based on age, severity of illness or presence of cognitive impairment, as long as the person is able to complete the research assessments.

研究组 & 干预措施

Patients with diagnosis of Parkinson's Disease, Parkinsonism and Movement Disorders

干预措施: Observation (Other)

Patients affected by cognitive impairment (CI) and dementia

干预措施: Observation (Other)

结局指标

主要结局

To monitor and predict the course of neurodegenerative diseases through the study of clinical markers and the creation of AI-models

时间窗: Baseline to 120 months

To identify markers of neurodegenerative disease progression for use in clinical monitoring

次要结局

  • To predict the risk to develop neurodegenerative diseases through the study of clinical markers and the creation of AI-models(Baseline to 120 months)

研究者

发起方
Casa di Cura San Raffaele Cassino
申办方类型
Network
责任方
Sponsor

研究点 (2)

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