Actively Recruiting
Lecanemab for Early Onset Familial Alzheimer's Disease
Led by RenJi Hospital · Updated on 2025-03-19
114
Participants Needed
15
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lecanemab for Early Onset Familial Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years at disease onset, any gender
- Diagnosis of Alzheimer's Disease or mild cognitive impairment meeting NIA-AA 2011 criteria
- Confirmed amyloid beta positivity by PET/CT, PET/MRI, or cerebrospinal fluid testing
- Mini-Mental State Examination score of 21 or higher, or Montreal Cognitive Assessment score of 17 or higher, or Clinical Dementia Rating of 0.5
- No significant neurological signs on examination
- Ability to complete cognitive tests and other assessments
- Informed consent signed by participant and legal guardian prior to study procedures
You will not qualify if you...
- Cognitive decline caused by other diseases like cerebrovascular disease, infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, or other physical/chemical causes
- Significant systemic diseases such as hepatic or pulmonary encephalopathy
- Intracranial lesions like subdural hematoma or brain tumor
- Endocrine disorders such as thyroid or parathyroid disease
- Dementia due to vitamin deficiencies or other causes
- Stroke, transient ischemic attack, bleeding disorders, or seizures within past 12 months
- Psychiatric disorders including schizophrenia, bipolar disorder, major depression, or delirium
- Unstable or severe heart, lung, liver, kidney, or blood diseases; known cancers or serious prognoses
- Cerebral amyloid angiopathy-related inflammation or beta-amyloid-related cerebral vasculitis
- Uncorrectable vision or hearing impairments preventing assessments
- MRI contraindications such as claustrophobia, pacemakers, defibrillators, or metal implants
- MRI findings with multiple microhemorrhages, vascular edema, white matter disease, multiple strokes, or other brain abnormalities
- Use of warfarin, vitamin K antagonists, direct oral anticoagulants, heparin, or thrombolysis
- Coagulation disorders
- Pregnancy or lactation
- Severe allergies to lecanemab or its components
- Other conditions deemed unsuitable by clinicians
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Xuanwu Hospital, Capital Medical University
Beijing, China, China
Actively Recruiting
2
The Second Affiliated Hospital of Guangzhou Medical University
Guangdong, China, China
Actively Recruiting
3
The Affiliated Hospital of Guizhou Medical University
Guizhou, China, China
Actively Recruiting
4
Nanjing Brain Hospital
Jiangsu, China, China
Actively Recruiting
5
Nanjing Drum Tower Hospital
Jiangsu, China, China
Actively Recruiting
6
Nantong First People's Hospital
Jiangsu, China, China
Actively Recruiting
7
Huadong Hospital, Fudan University
Shanghai, China, China
Actively Recruiting
8
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, China
Actively Recruiting
9
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, China
Actively Recruiting
10
Shanghai Mental Health Center
Shanghai, China, China
Actively Recruiting
11
West China Hospital of Sichuan University
Sichuan, China, China
Actively Recruiting
12
Tianjin Medical University General Hospital
Tianjin, China, China
Actively Recruiting
13
Jinhua Central Hospital
Zhejiang, China, China
Actively Recruiting
14
Ningbo Second Hospital
Zhejiang, China, China
Actively Recruiting
15
The First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang, China, China
Actively Recruiting
Research Team
J
Jinwen Xiao
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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