An observational study in Alzheimer Disease, sponsored by RenJi Hospital. Recruiting at 15 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by RenJi Hospital · Observational
The goal of this observational study is to learn about the efficacy of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for a total of 18 months and will undergo cognitive assessments, PET and MRI scans, blood/fluid tests and whole genome sequencing. The study will explore the effects of genetic and hereditary factors on the efficacy of Lecanemab treatment in early-onset familial AD patients.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 114 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Renji Hospital, Shanghai Jiao Tong University School of Medicine Xuanwu Hospital, Capital Medical University Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Mental Health Center The First Affiliated Hospital, Zhejiang University School of Medicine The Second Affiliated Hospital of Guangzhou Medical University West China Hospital of Sichuan University Tianjin Medical University General Hospital Nantong First People's Hospital Huadong Hospital, Fudan University Jinhua Central Hospital Ningbo Second Hospital Nanjing Drum Tower Hospital Nanjing Brain Hospital The Affiliated Hospital of Guizhou Medical University
Exclusion Criteria:
Chang of CDR-SB score
CDR-SB, clinical dementia rating-sum of boxes
Time frame: baseline, 9 month, 18 month
Change of amyloid burden
AV45-PET
Time frame: baseline, 9 month, 18 month
Change of ADAS-cog score
ADAS-cog, the Alzheimer's Disease Assessment Scale-Cognitive Subscale
Time frame: baseline, 9 month, 18 month
Change of ADCS-ADL score
ADCS-ADL, the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL)
Time frame: baseline, 9 month, 18 month
Change of MoCA score
MoCA, the Montreal Cognitive Assessment
Time frame: baseline, 9 month, 18 month
Change of BNT score
BNT, the Boston Naming Test
Time frame: baseline, 9 month, 18 month
Change of TMT score
TMT, the trail making test
Time frame: baseline, 9 month, 18 month
Change of HAMA and HAMD score
HAMA, Hamilton Anxiety Scale; HAMD, Hamilton Depression Scale
Time frame: baseline, 9 month, 18 month
Change of biomarkers
p-tau181, p-tau217, Aβ40, Aβ42 , pEAβ3-42, GFAP, NFL, TRPC6 ( blood, urine, feces, gingival crevicular fluid, cerebrospinal fluid)
Time frame: baseline, 9 month, 18 month
Positron emission tomography (PET)
Other PET including FDG-PET, Tau-PET, TSPO-PET, SV2A-PET, exendin-4 (GLP-1R)-PET, colinergic receptor probe (ASEM) PET
Time frame: baseline, 9 month, 18 month
Change of structural MRI
3D T1-weighted, 3D T2-weighted and Diffusion Tensor Imaging (DTI)
Time frame: baseline, 9 month, 18 month
Change of functional MRI
Blood oxygenation level dependent (BOLD) imaging
Time frame: baseline, 9 month, 18 month
Change of magnetic susceptibility
Quantitative susceptibility mapping (QSM) imaging
Time frame: baseline, 9 month, 18 month
Change of perfusion imaging
Arterial spin labeling (ASL) imaging
Time frame: baseline, 9 month, 18 month
Whole Genome Sequencing
Time frame: baseline
Change of speech information
Speech recording of Cookie-theft description task, using self-developed ASR speech analysis software (China software copyright number: 2016RS164680) for speech analysis
Time frame: baseline, 9 month, 18 month
Plan to share: No
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RenJi Hospital