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.
Age ≥ 45 years but ≤ 85 years;
Literacy level of elementary school and above (i.e., ≥3 years of education);
Fulfillment of the diagnostic criteria for probable AD in the NINCDS-ADRDA 2007 revision (or the diagnostic criteria for clinically probable AD in the National Institute on Aging and Alzheimer's Disease Association NIA-AA 2011 edition);
Clinical Dementia Rating Scale CDR-global = 1 point;
Those with a history of stroke and neurologic focal signs, head MRI scans excluding external infarct foci, brain softening foci and other occupying lesions, etc., as well as SWI sequences showing 5 or more microhemorrhagic foci, vascular malformations, etc;
Presence of other neurological disorders that may cause brain dysfunction (e.g., schizophrenia, severe anxiety and depression, frontotemporal lobe dementia, Huntington's disease, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, and normal cranial pressure hydrocephalus, etc.);
Presence of other systemic diseases that can cause cognitive impairment, such as hypothyroidism, folic acid and vitamin B12 deficiency, specific infections (e.g., syphilis, HIV), alcohol and drug abuse;
Presence of a history of severe hepatic or renal insufficiency, severe pulmonary insufficiency, severe anemia, severe gastrointestinal disorders, severe cardiac arrhythmias, cardiac infarction within 6 months, and malignant tumors;
Samples from a multicenter study cohort of early AD in Zhejiang Province (real-world study based on lencanumab treatment)
Cohort
Prospective
Not listed
Number 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
Aβ-PET
Aβ-PET scanning was conducted on enrolled patients to evaluate alterations in the quantity of amyloid plaque deposits within their brains.
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.
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.
Click on the lead sponsor to view all of their trials.
