Validation of the I-UDS Neuropsychological Battery in Patients With Mild Cognitive Impairment and Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- I-UDS battery
研究概览
简要总结
The current project entails the validation of the Italian version of the Uniform Data Set (I-UDS) neuropsychological in patients with neurodegenerative diseases, specifically in patients with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD). Specifically, the final aim is to explore the ability of the battery to differentiate the cognitive profiles of the two groups of patients.
详细描述
The harmonization of procedures for neuropsychological assessment in dementia disorders is essential for the development of shared activities and projects within the IRCCS Network of Neuroscience and Neurorehabilitation (RIN). To this end, a previous project of the network was dedicated to the translation and adaptation of the Uniform Data Set (UDS) neuropsychological battery, following the similar initiative of the National Alzheimer's Coordinating Center (NACC) USA . This project led to the creation of the I-UDS, which can be administered via a tablet application and consists of tests aimed at investigating different cognitive domains, namely memory, attention, language, executive and visuospatial skills. Normative data were obtained from a sample of 433 healthy participants. In order to be able to use the I-UDS battery in clinical and research settings, it is essential to validate its application in patients with neurodegenerative diseases. In particular, in line with the NACC initiative, the battery aims to trace and highlight the continuum between Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD). The present multicenter study therefore aims to test the I-UDS battery in patients with clinical diagnoses of MCI and AD, in order to explore its ability to differentiate the cognitive profiles of the two groups of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of MCI or AD based on diagnostic research criteria after a protocol of clinical, neuropsychological, structural brain imaging evaluation and biomarkers positivity assessment (amyloid-PET and/or CSF);
- •performance in the Mini-Mental State Examination (MMSE) above/equal 20 (score corrected for age and education);
排除标准
- •prior/current cerebrovascular disorders;
- •a history of traumatic brain injury, brain tumors, stroke;
- •concomitant medical, sensory and/or motor deficits possibly affecting performance;
- •a history of alcohol and/or drug abuse;
- •use of medications influencing cognitive functions.
结局指标
主要结局
I-UDS battery
时间窗: One time
Patients' scores in the tests of the I-UDS battery
次要结局
未报告次要终点
