NCT06217237已完成不适用
Phase II Neuroimaging Network: Optimization and Harmonization of Advanced MRI Sequences and Their Application in the Study of Dementia and Intellectual Disability in Pediatric Age
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Quantitative Susceptibility Mapping (QSM), Diffusion Weighted Imaging (DWI) - Diffusion Tensor Imaging (DTI), Fluid Attenuated Inversion Recovery (FLAIR)
研究概览
简要总结
Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.
详细描述
Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for patients
- •accident cases
- •time of onset of NOT MORE THAN 24 months
- •Clinical Dementia Rating Scale (CDR) <=2;
- •MoCA<=17
- •for controls absence of complaints of cognitive disorders and/or neurological/neuropsychological visits for the evaluation of such disorders;
- •for all Age >= 50 and <= 80;
- •Hachinski Ischemic Scale - 7 items < 2;
- •visual and/or auditory acuity sufficient to carry out the neuropsychological assessment;
- •if on neuropsychopharmacological therapy, stability for 4 weeks before the start of the study.
排除标准
- •any uncontrolled medical condition or neurological/neurodegenerative disease that, in the opinion of the recruiting physician, could contribute to the individual's cognitive impairment [e.g., kidney disease, liver disease, brain tumor, alcohol or drug abuse, abnormal thyroid function, hydrocephalus normotensive, vascular dementia, neurocognitive disorder due to head trauma (according to the diagnostic criteria of the DSM V)];
- •transient ischemic attack or stroke during the 12 months preceding screening; history of unstable angina, myocardial infarction, heart failure (New York Heart Association Class III or IV), or clinically significant heart rhythm disturbances documented within one year of screening;
- •history of malignant tumor disease, except: cancer in remission for more than 5 years since screening; prostate cancer in situ;
- •history of surgically treated squamous cell carcinoma or basal cell carcinoma;
- •impaired liver function or liver failure;
- •history or evidence of autoimmune disease considered clinically significant by the doctor or requiring the chronic use of corticosteroids or other immunosuppressive drugs;
- •clinically significant systemic illness or infection within 30 days of screening; comorbidity for primary psychiatric or neurological disorders;
- •absence of an informant (partner, relative, adult child or friend) who knows the subject well enough to be able to provide reliable information on his cognitive and functional abilities.
- •contraindication to carrying out the MRI exam.
结局指标
主要结局
Quantitative Susceptibility Mapping (QSM), Diffusion Weighted Imaging (DWI) - Diffusion Tensor Imaging (DTI), Fluid Attenuated Inversion Recovery (FLAIR)
时间窗: during MRI procedure
The main endpoint is the characterization of white matter alterations in different forms of dementing diseases through the combined study of MRI sequences. Specifically, we correlate Voxel Based Morphometry indices, DTI quantifcation and lesions volume with MMSE and MOCA scores.
次要结局
- FLAIR, QSM, DWI (DTI) for white matter study(during MRI procedureRMN date examination)
研究者
研究点 (1)
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