Study on Multimodal Imaging and Molecular Imaging Techniques in Degenerative Dementia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 8
- 主要终点
- The change of incidence of cognitive impairment
研究概览
简要总结
This project is a multicenter observational study that establishes a longitudinal cohort of patients with Alzheimer's disease and other dementias based on neuroimaging, molecular imaging, biological and digital markers to explore new solutions such as dementia disease mechanism, diagnosis, condition evaluation, and prognosis assessment.
详细描述
This project will build a longitudinal database based on multimodal MRI imaging information of dementia subjects, various body fluid or digital markers, and a cohort. The convolutional neural network algorithm will be used to explore the imaging characteristics of healthy controls, AD, FTD, and DLB, develop an early prediction model for degenerative dementia, and achieve early differential diagnosis of different dementia subtypes. This study further performed GE180, ASEM, and exendin-4 radionuclide imaging on some subjects who completed conventional PET (AV45, Tauvir, and FDG) imaging to explore the diagnostic efficacy of these three probes as new diagnostic probes for early AD. In addition, through longitudinal follow-up of Aβ-positive MCI patients, multimodal MRI and PET image fusion technology were used to explore the changes in fused images during their conversion to AD in order to obtain early and accurate diagnostic markers.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥50 and ≤85 years old, male or female;
- •Meet the diagnostic criteria for dementia or MCI;
- •Neuropsychological score: MMSE 15-28 points, CDR ≤ 1 point; ④ Patients and their families are informed and sign the informed consent form
排除标准
- •The presence of other neurological diseases that may cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.);
- •The presence of other systemic diseases that may cause cognitive impairment (such as liver dysfunction, renal dysfunction, thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);
- •Suffering from a disease that makes it impossible to cooperate with cognitive examinations;
- •The presence of contraindications to MRI;
- •The presence of mental and neurological retardation;
- •Refusing to draw blood;
- •Refusing to sign the informed consent form.
结局指标
主要结局
The change of incidence of cognitive impairment
时间窗: baseline, 1 year, 2 year, 3 year, 4 year
Number of participants who covert to AD or mild cognitive impairment (MCI) will be recorded to calculate the incidence.
次要结局
- The change of speech information(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of structural MRI(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of Geriatric Depression Scale (GDS)(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of electroencephalogram (EEG)(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of Mini-Mental State Examination (MMSE)(baseline, 1 year, 2 year, 3 year, 4 year)
- Positron emission tomography (PET)-MRI(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of Activities of daily living (ADL)(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of Montreal cognitive assessment-Basic (MoCA)(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of Auditory verbal learning test (AVLT)(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of functional MRI(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of magnetic susceptibility(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of perfusion MR imaging(baseline, 1 year, 2 year, 3 year, 4 year)
- The change of blood biomarker(baseline, 1 year, 2 year, 3 year, 4 year)