Cross-Cultural Longitudinal Study on Cognitive Decline (CLoCODE) for Subjective Cognitive Decline in China and Germany: A Protocol for Study Design

Article type: Research Article

Authors: Sheng, Can^a | Yang, Kun^{b; c} | He, Beiqi^d | Li, Taoran^a | Wang, Xiaoqi^a | Du, Wenying^a | Hu, Xiaochen^e | Jiang, Jiehui^f | Jiang, Xueyan^{a; d; g; *} | Jessen, Frank^{e; g; h; *} | Han, Ying^{a; d; i; j; *}

Affiliations: [a] Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China | [b] Evidence-Based Medicine Center, Xuanwu Hospital of Capital Medical University, Beijing, China | [c] Department of Epidemiology and Biostatistics, School of Public Health, Capital Medical University, Beijing, China | [d] Key Laboratory of Biomedical Engineering of Hainan Province, School of Biomedical Engineering, Hainan University, Haikou, China | [e] Department of Psychiatry and Psychotherapy, Medical Faculty, University of Cologne, Cologne, Germany | [f] Institute of Biomedical Engineering, School of Information and Communication Engineering, Shanghai University, Shanghai, China | [g] German Center for Neurodegenerative Diseases (DZNE), Bonn, Germany | [h] Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Cologne, Germany | [i] Center of Alzheimer’s Disease, Beijing Institute for Brain Disorders, Beijing, China | [j] National Clinical Research Center for Geriatric Disorders, Beijing, China

Correspondence: [*] Correspondence to: Ying Han, Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China, 100053. Tel.: +86 18515692701; Fax: +86 10 83167306; E-mail: [email protected]; Frank Jessen, Department of Psychiatry, Medical Faculty, University of Cologne, 50924 Cologne, Germany. E-mail: [email protected]; Xueyan Jiang, Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing, China, 100053. E-mail: [email protected].

Abstract: Background:Subjective cognitive decline (SCD) is considered as the first symptomatic manifestation of Alzheimer’s disease (AD), which is also affected by different cultural backgrounds. Establishing cross-cultural prediction models of SCD is challenging. Objective:To establish prediction models of SCD available for both the Chinese and European populations. Methods:In this project, 330 SCD from China and 380 SCD from Germany are intended to be recruited. For all participants, standardized assessments, including clinical, neuropsychological, apolipoprotein E (APOE) genotype, blood, and multi-parameter magnetic resonance imaging (MRI) at baseline will be conducted. Participants will voluntarily undergo amyloid positron emission tomography (PET) and are classified into amyloid-β (Aβ) positive SCD (SCD+) and Aβ negative SCD (SCD-). First, baseline data of all SCD individuals between the two cohorts will be compared. Then, key features associated with brain amyloidosis will be extracted in SCD+ individuals, and the diagnosis model will be established using the radiomics method. Finally, the follow-up visits will be conducted every 12 months and the primary outcome is the conversion to mild cognitive impairment or dementia. After a 4-year follow-up, we will extract factors associated with the conversion risk of SCD using Cox regression analysis. Results:At present, 141 SCD from China and 338 SCD from Germany have been recruited. Initial analysis showed significant differences in demographic information, neuropsychological tests, and regional brain atrophy in SCD compared with controls in both cohorts. Conclusion:This project may be of great value for future implications of SCD studies in different cultural backgrounds.Trial registration: ClinicalTrials.gov, NCT04696315. Registered 3 January 2021.

Keywords: Alzheimer’s disease, amyloid, cross-cultural, magnetic resonance imaging, radiomics, subjective cognitive decline

DOI: 10.3233/JAD-215452

Journal: Journal of Alzheimer's Disease, vol. 87, no. 3, pp. 1319-1333, 2022