Prediction of Cognitive Decline by Neuroimaging Techniques and the Application in Diagnosis and Treatment of Preclinical AD (Sino Longitudinal Study on Cognitive Decline, SILCODE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The altered volume pattern in SCD/SCD-plus with progression.
研究概览
简要总结
This study is affiliated to Sino Longitudinal Study on Cognitive Decline, SILCODE. To establish models of normal and pathological cognitive aging.To collect the longitudinal data of SCD population, to study the dynamic changes of brain networks so as to explore the progressive mechanisms of AD on brain networks and to construct a high-precision multi-modal model for early diagnosis.
详细描述
This study is affiliated to Sino Longitudinal Study on Cognitive Decline, SILCODE. Alzheimer's disease (AD) is the most common cause of dementia, which severely injures multiple domains of cognitive functions in the aging people, bringing heavy burden to the society and families. Studying the cognitive brain damage mechanism of subjective cognitive decline (SCD), the preclinical stage of AD, would provide great opportunities for understanding the pathogenesis of AD and clinical value for early diagnosis and intervention in AD. The project intends to utilize amyloid-PET and FDG-PET for screening and then employ the comprehensive neuropsychological examination combined with multi-modal MRI neuroimaging techniques to study the brain functions and structures of the normal aging and SCD. The imaging data would be analyzed from several levels, including the cognitive dimensions, brain activation patterns, and especially functional and structural networks to establish the models of normal and pathological cognitive aging, which mainly be modulated by frontal-parietal control system. We aim to establish models of normal and pathological cognitive aging. Furthermore, the longitudinal data of SCD population would be collected to study the dynamic changes of brain networks so as to explore the progressive mechanisms of AD on brain networks and to construct a high-precision multi-modal model for early diagnosis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than 60, right handedness, Han nationality;
- •Have no cognitive decline complains, with neither worry nor concern about their cognition;
- •Scores of standardized neuropsychological tests scale adjusted for age, sex and education are in normal range;
- •Physical examination is negative;
- •Review medical history and family history is negative, accessory examination don't show disease could cause cognitive decline;
- •Could cooperate collection of multi-modal magnetic resonance imaging, once a year, for continueously five years.
- •SCD Inclusion Criteria:
- •Presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event;
- •Failure to meet the following criteria for MCI.
- •3.SCD-plus Inclusion Criteria:
- •Presence of self-perceived continuous cognitive decline compared to previous normal status and unrelated to an acute event;
- •Concerns (worries) associated with memory complaint;
- •Failure to meet the following criteria for MCI.
- •MCI Inclusion Criteria:
- •Clinical Dementia Rating (CDR) score of 0.5 as well as failure to meet the criteria for dementia
- •Having impaired scores (defined as >1 SD below the age-corrected normative mean) on both measures within at least one cognitive domain (i.e., memory, language, or speed/executive function);
- •Having impaired scores in each of the three cognitive domains sampled;
- •the Functional Activities Questionnaire (FAQ) ≥
- •AD Inclusion Criteria The diagnosis of AD syndrome is based on the diagnostic guidelines for dementia due to AD delivered by the National Institute on Aging-Alzheimer's Association workgroups (NIA-AA)with a total CDR score of 1.
排除标准
- •Claustrophobia, with metals in the body that cannot be examined by MRI, including metal dentures or other contraindications for examination;
- •Left handedness or ambidextrality.
结局指标
主要结局
The altered volume pattern in SCD/SCD-plus with progression.
时间窗: 5 years
1. Global grey matter volume change of brain in µm3 2. Regional gray matter volume change of brain in µm3 3. Cerebral cortex thickness change of brain in µm
The altered functional MRI pattern in SCD/SCD-plus with progression.
时间窗: 5 years
Resting state functional MRI blood-oxygen-level-dependent (fMRI BOLD) signal.
Genotype of SCD/SCD-plus with progression.
时间窗: 5 years
ApoE genotype by blood test.
AD7c-NTP level of SCD/SCD-plus with progression.
时间窗: 5 years
AD7c-NTP level by urine tests.
The altered AV45-PET pattern in SCD/SCD-plus with progression.
时间窗: 5 years
Global SUVR change of brain of AV45-PET in kBq/ml/MBq/kg.
Gut microbiota of SCD/SCD-plus with progression.
时间窗: 5 years
Gut microbiota level by 16s rDNA sequencing
The altered FDG-PET pattern in SCD/SCD-plus with progression.
时间窗: 5 years
Global SUVR change of brain of FDG-PET in kBq/ml/MBq/kg.
The altered DTI pattern in SCD/SCD-plus with progression.
时间窗: 5 years
1. Regional fractional anisotropy (FA), measured by diffusion tensor imaging (DTI). 2. Regional mean diffusivity (MD), measured by DTI. 3. Regional radial diffusivity (RD), measured by DTI. 4. Regional axial diffusivity (AxD), measured by DTI.
次要结局
未报告次要终点
研究者
XuanwuH 2
Director of Neurology, Professor
Xuanwu Hospital, Beijing