Actively Recruiting
Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2026-05-22
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multi-center, randomized trial to evaluate the efficacy and safety of Lecanemab in patients with early-to-moderate Alzheimer's Disease. The study integrates multiple omics data, including eye imaging (OCT/OCTA) and brain MRI, along with cognitive tests such as ADAS-Cog, MoCA, and CDR scores. Monitoring for ARIA, a significant safety concern in amyloid-targeting therapies, is also a key focus. Participants will be randomly assigned to either receive Lecanemab via intravenous infusion at a dose of 10 mg/kg or conventional anti-dementia treatment, which typically involves cholinesterase inhibitors like donepezil. Lecanemab is administered over 60 minutes with a specialized infusion system. The study lasts 24 months, with evaluations at baseline, 6, 12, 18, and 24 months. During the trial, participants will undergo various assessments including amyloid PET scans to measure brain amyloid changes, retinal and cerebral imaging, and cognitive evaluations at multiple time points. Researchers will track changes in brain structure and function through MRI and monitor safety through clinical evaluations. The study aims to provide detailed insights into Lecanemab's impact on Alzheimer's progression and patient cognition over two years.
CONDITIONS
Brief Title
Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 90 years old
- No gender restrictions
- Diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease
- Mini-Mental State Examination (MMSE) score of 20 or higher
- Overall Clinical Dementia Rating (CDR) score of 0.5 or 1 point
- Positive amyloid protein confirmed by amyloid-PET or cerebrospinal fluid (CSF) analysis
- Reliable caregiver available to accompany patient and supervise study drug use
- Agreement to participate and signed informed consent form
You will not qualify if you...
- Cognitive impairment caused by conditions other than Alzheimer's Disease
- History of transient ischemic attack (TIA), stroke, cerebral hemorrhage, or epileptic seizure within 12 months before screening
- Hamilton Depression Scale score over 17 or recent suicidal behavior within 6 months before screening
- Psychiatric conditions interfering with study participation (hallucinations, anxiety, delusions)
- Hemorrhagic diseases or receiving anticoagulant therapy
- Presence of malignant tumors or severe gastrointestinal, kidney, liver, respiratory, immune, endocrine, or cardiovascular diseases affecting the study
- Hypersensitivity to Lecanemab or components of the injection
- Contraindications to MRI scans, including certain implanted devices
- History or suspicion of drug or alcohol abuse within 2 years before screening
- Participation in clinical studies with therapeutic monoclonal antibodies or novel AD treatments within 6 months before screening unless placebo group
- Planned surgical operations under general anesthesia during the study period
- Positive pregnancy test, breastfeeding, or pregnant at screening or baseline visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants receive either Lecanemab via intravenous infusion or conventional anti-dementia treatment for Alzheimer's disease.
Visits at baseline, 6 months, 12 months, and 18 months
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
Z
Zhen Wang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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