Actively Recruiting
An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-09-04
400
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45 and 85 years
- At least 3 years of education (elementary school level or above)
- Diagnosis of mild Alzheimer's disease or mild cognitive impairment due to Alzheimer's disease with positive amyloid PET scan
- Clinical Dementia Rating Scale global score of 1 for mild Alzheimer's disease or 0.5 for mild cognitive impairment
- Meeting the diagnostic criteria for probable Alzheimer's disease or mild cognitive impairment as specified
- Normal control participants aged 55 to 85 years with no significant amyloid deposition and normal cognitive scores
You will not qualify if you...
- History of stroke or neurological issues including infarcts, brain softening, or more than 5 microhemorrhagic foci on MRI
- Other neurological disorders causing brain dysfunction such as schizophrenia, severe anxiety/depression, frontotemporal dementia, Huntington's disease, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, or normal pressure hydrocephalus
- Systemic diseases causing cognitive impairment like hypothyroidism, vitamin deficiencies, infections (syphilis, HIV), alcohol or drug abuse
- Severe hepatic, renal, pulmonary insufficiency, severe anemia, gastrointestinal disorders, cardiac arrhythmias, recent heart attack, or malignant tumors
- Use of oral anticoagulants including warfarin and new oral anticoagulants
- Contraindications to MRI such as metal implants
- Conditions preventing cooperation with cognitive testing such as aphasia or impaired consciousness
- Refusal to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
2
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
G
Guoping Peng, PhD
CONTACT
X
Xiaoyan Liu, PhD
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
2
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