Alzheimer Disease Clinical Trial
Official title:
Comparison of Subjective Cognitive Decline Between the German and Chinese and Early Diagnosis of Alzheimer's Disease Based on Radiogenomics
The incidence of AD dementia is increasing due to the aging population, putting a heavy burden on our society and economics. Exploring the mechanisms underlying SCD due to preclinical AD has scientific and clinical significance. However, it is challenging to construct and validate the preclinical diagnosis model of AD with fused multimodel information across culture/race. From the cooperation during the past five years, we have established cohorts by synchronized assessment, achieved consensus on SCD features extraction and made a breakthrough in the application of multiple parameter MRI with German collaborators. Therefore, in this project, SCD with and without amyloid pathology will be compared by clinical and cognitive data, genetics, blood and MRI biomarkers between the German and Chinese. Key features will be extracted and specific characteristics of SCD due to preclinical AD as well as risk factors for conversion between two countries will be clarified. Then the diagnosis model of preclinical AD in SCD will be established across culture/race based on radiogenomics, which will improve the current diagnostic system of AD. Through this project, the value of SCD in the etiologic, anatomical and quantitative diagnosis of preclinical AD will be identified to improve sensitivity and specificity of preclinical AD diagnosis in clinical practice.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 60 Years to 79 Years |
Eligibility | Inclusion Criteria: - 60-79 years old, right-handed and Mandarin-speaking subjects; - self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event; - normal age-, gender- and education-adjusted performance on standardised cognitive tests; - concerns (worries) associated with memory complaint; - failure to meet the criteria for MCI or dementia Exclusion Criteria: - a history of stroke; - major depression (Hamilton Depression Rating Scale score > 24 points); - other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy; - cognitive impairment caused by traumatic brain injury; - systemic diseases, such as thyroid dysfunction, syphilis and HIV; - a history of psychosis or congenital mental growth retardation |
Country | Name | City | State |
---|---|---|---|
China | Department of Neurolgy, Xuanwu Hospital of Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
XuanwuH 2 | University of Cologne |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biomarkers associated with amyloid deposition | SCD with the evidence of brain amyloid deposition is considered as preclinical AD. The investigators aim to extract multiple features involving neuroimaging, gene sequencing, blood, and clinical data to identify individuals with amyloid+ from SCD persons. These features associated with amyloid deposition are valuable biomarkers for early diagnosis of AD. | Four years | |
Secondary | Predicted biomarkers associated with conversion to cognitive impairment | Individuals with SCD will be followed for four years. The investigators aim to characterize those who convert to mild cognitive impairment or dementia during the follow-up, and further find the predicted factors associated with the progression of AD. | Four years |
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