The goal of this observational study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.
This study was a prospective observational study of a patient population treated or planning to be treated with lencanemab from a multicenter cohort of patients with early-stage AD in Zhejiang Province. It was a real-world study based on the treatment of lencanemab. The primary enrollment population was patients with mild AD or mild AD-origin cognitive disorders who had completed positive Aβ-PET scans that met the PET quality-control criteria and who were receiving treatment with lencanemab. Patients with cognitive impairment were divided into two subgroups: those receiving donepezil treatment alone and those receiving lencanemab combined with standard treatment with donepezil. Fresh plasma was collected at baseline, 3 months of follow-up, 6 months of follow-up, 12 months of follow-up, and 18 months of follow-up, respectively. Amyloid PET scanning was performed at 12 months of follow-up and 18 months of follow-up. In order to evaluate the sensitivity and specificity of different blood biomarkers for monitoring and assessing the alleviation of amyloid pathology progression by Aβ-PET-confirmed lencanumab treatment, blinded peripheral blood AD core marker assays were performed in the main central laboratory. Furthermore, the aim was to provide a follow-up tool suitable for clinical blood marker-based monitoring of lencanumab treatment.
Study Type
OBSERVATIONAL
Enrollment
400
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGThe First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGNumber of participants with blood biomarkers
Blinded peripheral blood AD core marker testing including but not limited to Aβ40, Aβ42, total tau, p-tau181/217, NFL, GFAP
Time frame: Fresh plasma was collected at baseline, 3 months of follow-up, 6 months of follow-up, 12 months of follow-up, and 18 months of follow-up, respectively
Aβ-PET
Aβ-PET scanning was conducted on enrolled patients to evaluate alterations in the quantity of amyloid plaque deposits within their brains.
Time frame: Amyloid PET scan at 12 months follow-up, 18 months follow-up
Cognitive funtion - MMSE
Multidimensional neuropsychological assessment is mainly used to assess the cognitive function of patients. MMSE is widely used in cognitive dysfunction which consists of the following ten parts: orientation, memory, attention and numeracy, ability to recall, language skills, including naming ability, retelling ability, three-step command, reading ability, writing ability. The values range from 0 to 30, with higher score indicating better outcome.
Time frame: was collected at baseline, 3 months of follow-up, 6 months of follow-up, 12 months of follow-up, and 18 months of follow-up, respectively
Cognitive funtion - MoCA
Multidimensional neuropsychological assessment is mainly used to assess the cognitive function of patients. MoCA is also an assessment tool for rapid screening of cognitive dysfunction, including 8 cognitive domains such as visual structure skills, executive function, memory, language, attention and concentration, calculation, abstract thinking and orientation. The values range from 0 to 30, with higher score indicating better outcome.
Time frame: was collected at baseline, 3 months of follow-up, 6 months of follow-up, 12 months of follow-up, and 18 months of follow-up, respectively
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