试验雷达 AI | ||
|---|---|---|
临床试验 NCT06596746 (MARKERS-NDD) 针对神经退行性疾病，帕金森病，突触核蛋白病，路易体病，多系统萎缩，Tau蛋白病，阿尔茨海默病，皮质基底变性，Supranuclear Palsy, Progressive，非典型帕金森综合征，TDP-43 Proteinopathies，肌萎缩侧索硬化症，额颞叶退行性变，运动障碍，认知障碍，痴呆，铁过载，伴脑铁沉积的神经退行性变 (NBIA)目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
Neurodegenerative Diseases Progression Markers (MARKERS-NDD) 600 观察性
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT06596746 (MARKERS-NDD)是一项针对神经退行性疾病，帕金森病，突触核蛋白病，路易体病，多系统萎缩，Tau蛋白病，阿尔茨海默病，皮质基底变性，Supranuclear Palsy, Progressive，非典型帕金森综合征，TDP-43 Proteinopathies，肌萎缩侧索硬化症，额颞叶退行性变，运动障碍，认知障碍，痴呆，铁过载，伴脑铁沉积的神经退行性变 (NBIA)的观察研究试验，目前试验状态为招募中。试验始于2024年9月9日，计划招募600名患者。该研究由Casa di Cura San Raffaele Cassino主导，预计于2034年9月9日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年9月19日。
简要概括
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 analyse...显示更多
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 affect...显示更多
官方标题
Neurodegenerative Diseases Progression Markers (MARKERS-NDD): a Real-world Data Longitudinal Prospective Study
疾病
神经退行性疾病帕金森病突触核蛋白病路易体病多系统萎缩Tau蛋白病阿尔茨海默病皮质基底变性Supranuclear Palsy, Progressive非典型帕金森综合征TDP-43 Proteinopathies肌萎缩侧索硬化症额颞叶退行性变运动障碍认知障碍痴呆铁过载伴脑铁沉积的神经退行性变 (NBIA)其他研究标识符
- MARKERS-NDD
- 001-2024
NCT编号
实际开始日期
2024-09-09
最近更新发布
2024-09-19
预计完成日期
2034-09-09
计划入组人数
600
研究类型
观察研究
试验状态
招募中
关键词
Neurodegenerative Diseases
Markers
Gait analysis
Wearable inertial sensors
IMU
Artificial intelligence
AI-Video gait analysis
Handwriting analysis
Voice-based artificial intelligence systems
imaging
multimodal analysis
electroencephalogram
cortical activity
gut microbiota
laboratory blood chemistry parameters
Markers
Gait analysis
Wearable inertial sensors
IMU
Artificial intelligence
AI-Video gait analysis
Handwriting analysis
Voice-based artificial intelligence systems
imaging
multimodal analysis
electroencephalogram
cortical activity
gut microbiota
laboratory blood chemistry parameters
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Patients with diagnosis of Parkinson's Disease, Parkinsonism and Movement Disorders | 观察 In MARKERS-NDD up to 600 participants will be enrolled and followed longitudinally once identified, over the course of 1-10 years |
Patients affected by cognitive impairment (CI) and dementia | 观察 In MARKERS-NDD up to 600 participants will be enrolled and followed longitudinally once identified, over the course of 1-10 years |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
To monitor and predict the course of neurodegenerative diseases through the study of clinical markers and the creation of AI-models | To identify markers of neurodegenerative disease progression for use in clinical monitoring | Baseline to 120 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
To predict the risk to develop neurodegenerative diseases through the study of clinical markers and the creation of AI-models | To identify markers of neurodegenerative disease for use in early clinical diagnosis | Baseline to 120 months |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
最低年龄要求
10 Years
适龄性别
全部
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.
- 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.
Casa di Cura San Raffaele Cassino- 🏛️IRCCS S...
研究中心联系人
联系人: Maria Francesca De Pandis, MD, PhD, Neurologist, 0776394740, [email protected]
联系人: Maria Gaglione, 0776394740, [email protected]
1 位于 1 个国家/地区的研究中心
Frosinone
San Raffaele Cassino, Cassino, Frosinone, 03043, Italy
Maria Francesca De Pandis, MD, PhD, 联系人, [email protected]
Maria Gaglione, 联系人, 0776394740, [email protected]
Maria Francesca De Pandis, MD, PhD, Neurologist, 主要研究者
招募中