Synaptic Vesicle Glycoprotein 2A-PET/CT and PET/MRI Combined Clinical Criteria Score in the Diagnosis of Early Cognitive Alteration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- SUVR（Standardized Uptake Value Ratio）
研究概览
简要总结
Using SV2A-PET to character a cohort of patients with early cognitive impairment using the novel synaptic probe 18F-labeled difluoro-analog of UCB-J（also known as 18F-SDM-8）
详细描述
A community-based population (Han Chinese) in Hefei, China, based on the CANDI cohort；Single-center prospective case-control study；The projected enrollment population is 80; 40 patients with Alzheimer's Disease（AD）, 30 patients with Mild Cognitive Impairment（MCI）; 10 healthy controls. Diagnostic experiments and predictive prognostic experiments with new probes.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All diagnostic criteria for AD patients met the National Institute of Neurological Speech-Language Disorders Stroke Institute and Alzheimer's Disease and Related Disorders Association criteria;
- •Comply with the American Psychiatric Association Diagnostic and Statistical Workbook of Mental Disorders, 5th edition (DSMIV);
- •All subjects were unconscious and could be accompanied by behavioral and psychiatric abnormalities. Subjects who meet the above criteria are eligible for enrollment.
- •Those who understand the process of this clinical trial and sign the informed consent form (in addition, non-AD volunteers will be recruited through verbal dissemination and posting of paper advertisements to serve as the non-AD control group, and the final control group will be screened by the clinician and consist of healthy people of similar age and gender).
- •MCI Group
- •Concerns about cognitive changes, and concerns about finding changes in comparison with one's prior level may originate from the patient himself or herself, from an informed person, or from an experienced specialist;
- •Impairment of one or more cognitive areas, primarily memory, executive function, attention, language, and visuospatial function;
- •Maintaining independence in daily living, there can be minor impairment in complex instrumental daily abilities;
- •Absence of dementia, mild disease, and no evidence of serious impairment of social or occupational abilities;
- •Presence of one of the Aβ class biomarkers and/ neuronal damage class markers detected by imaging, cerebrospinal fluid;
- •All subjects and their guardians give informed consent to the study and sign the informed consent form;
排除标准
- •With confirmed cerebrovascular disease, the presence of multiple or extensive cerebral infarcts;
- •Other types of dementia: Parkinson's disease dementia, vascular dementia, frontotemporal lobe dementia, dementia with Lewy bodies;
- •Sudden onset or stroke-like episodes;
- •Early onset of focal neurological symptoms, such as hemiparesis, computational deficits, ataxia, or sensory loss;
- •Seizures or gait abnormalities early in the onset of the disease;
- •Evidence of drug applications that cause significant effects on cognitive function;
- •Those who are allergic to alcohol;
- •Persons with alcohol allergy; (ix) Persons with left-handedness; (x) Persons with left-handedness;
- •Those with claustrophobia or other reasons for not being able to cooperate with the examination;
- •Those with serious heart, liver, lung, kidney and other organ diseases, meeting the above conditions were excluded from the group.
结局指标
主要结局
SUVR（Standardized Uptake Value Ratio）
时间窗: 1year
Standardized semi-quantitative values of SUVR for each brain region of the cerebral cortex；Standardized Uptake Value ratio (SUVr) is a metric used to evaluate the results of PET scans of the brain. It is a measure of the extent of abnormal metabolism or abnormal deposits in a brain region by comparing the uptake value of a specific brain region to the uptake values of neighboring regions. SUVr is calculated as follows: 1. first, a reference region is selected, usually an adjacent region of healthy tissue that is unaffected by disease. 2. then, the uptake value for the region of interest (e.g., the brain region), denoted as SUV, is calculated. 3. next, the average uptake value of the reference region, denoted as SUVref, is calculated. 4. finally, the SUVr is calculated, obtained by dividing the SUV of the region of interest by the SUVref of the reference region.
次要结局
- AUC（Area under the curve）of SUVR(1year)