RecruitingNCT06883019

Lecanemab for Early Onset Familial Alzheimer's Disease

A Real World Study of Lecanemab Treatment in Participants with Early Onset Familial Alzheimer's Disease


Sponsor

RenJi Hospital

Enrollment

114 participants

Start Date

Mar 13, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing lecanemab — a drug that targets abnormal amyloid protein buildup in the brain — in people with early-onset familial Alzheimer's disease (where symptoms appear at age 65 or younger, often due to a genetic predisposition). **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with mild cognitive impairment or mild Alzheimer's disease - Your diagnosis has been confirmed by brain imaging or spinal fluid testing showing amyloid buildup - You score within a certain range on standard memory tests (MMSE or MoCA) - You and your legal guardian can give informed consent **You may NOT be eligible if...** - Your memory problems are caused by something other than Alzheimer's (e.g., stroke, Parkinson's, vitamin deficiency, infection) - You have had a stroke, bleeding disorder, or seizures in the past 12 months - You have serious heart, lung, liver, kidney, or blood conditions - You are on blood thinners (warfarin, heparin, or similar drugs) - You are unable to undergo MRI scans - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(15)

Xuanwu Hospital, Capital Medical University

Beijing, China, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangdong, China, China

The Affiliated Hospital of Guizhou Medical University

Guizhou, China, China

Nanjing Brain Hospital

Jiangsu, China, China

Nanjing Drum Tower Hospital

Jiangsu, China, China

Nantong First People's Hospital

Jiangsu, China, China

Huadong Hospital, Fudan University

Shanghai, China, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, China

Shanghai Mental Health Center

Shanghai, China, China

West China Hospital of Sichuan University

Sichuan, China, China

Tianjin Medical University General Hospital

Tianjin, China, China

Jinhua Central Hospital

Zhejiang, China, China

Ningbo Second Hospital

Zhejiang, China, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Zhejiang, China, China

View Full Details on ClinicalTrials.gov

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NCT06883019


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