Abstract
Introduction: To develop appropriate strategies for early diagnosis and intervention of cognitive impairment, the identification of minimally invasive and cost-effective biomarkers for the early diagnosis of cognitive impairment is crucial and desirable. Therefore, the CHina registry study on cOgnitive imPairment in the Elderly (HOPE) study is designed to investigate the natural course of cognitive decline and explore the clinical, imaging, and biochemical markers for the detection and diagnosis of cognitive impairment on its earliest stage.Methods: Approximately 5,000 Chinese elderly aged more than 50 years were recruited from Sun Yat-sen Memorial Hospital, Sun Yat-sen University in Guangzhou, China by the year 2024. All subjects were invited to complete the clinical assessment, neuropsychological assessment, the biological samples collection (blood and cerebrospinal fluid (CSF)], magnetic resonance imaging (MRI) examination, and optional amyloid and tau PET. The follow-up survey was conducted every 1 year to repeat these assessments for 20 years. To better clarify the relationship between potential risk factors and endpoint events [changes in cognitive score or incidence of mild cognitive impairment (MCI) and/or dementia], appropriate statistical methods were used to analyze the data, including but not limited to, such as linear mixed-effect model, competing risk model, or the least absolute shrinkage and selection operator model.Significance: The CHina registry study on cOgnitive imPairment in the Elderly study is designed to explore the longitudinal changes in characteristics of participants with cognitive decline and to identify potential plasma and imaging biomarkers with cost-benefit and scalability advantages. The results will enable broader clinical access and efficient population screening and then improve the development of treatment and the quality of life for cognitive impairment at the early stage.Trial registration number: NCT04360200.
Highlights
To develop appropriate strategies for early diagnosis and intervention of cognitive impairment, the identification of minimally invasive and cost-effective biomarkers for the early diagnosis of cognitive impairment is crucial and desirable
The associations between possible protective or risk factors, endpoint events, and the corresponding prediction models were clarified by using appropriate statistical methods to analyze the data, e.g., logistic regression model, survival curve, or cox regression model for binary variables with time; competing risk model for taking death or other cardio-cerebrovascular diseases into account as competing events with mild cognitive impairment (MCI) or dementia; linear mixed-effect model for repeated measurement data; and the least absolute shrinkage and selection operator (LASSO) model for developing the predictive model with a large number of predictors
This study evaluates the longitudinal progression process of cognitive decline and its related factors within 20 years in the Chinese elderly
Summary
To develop appropriate strategies for early diagnosis and intervention of cognitive impairment, the identification of minimally invasive and cost-effective biomarkers for the early diagnosis of cognitive impairment is crucial and desirable. In June of 2021, Food and Drug Administration (FAD) has approved the first AD-treatment drug, aducanumab, which can delay the progression of AD by clearing the amyloid-β (Aβ), (Sevigny et al, 2016; Schneider, 2020) the earliest pathological signature of AD in the brain (Hardy and Selkoe, 2002; Masters et al, 2015; Jack et al, 2018). It further emphasizes the importance of the diagnosis and treatment of cognitive impairment, especially in its early stage
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