This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. The study will run over a period of 24 months, with evaluations conducted at baseline, 6 months, and 12 months, 18 months and 24 months. Data from multiple omics layers will be integrated to assess both the efficacy and safety of the treatment.
The primary aim of this study is to assess the efficacy and safety of Lecanemab in patients with Alzheimer's Disease, leveraging multi-omics approaches. Specifically, the study will integrate data from OCT/OCTA imaging of the eye and MRI imaging of the brain, as well as cognitive measures such as ADAS-Cog, MoCA and CDR scores. Furthermore, the presence of ARIA-a significant safety concern in amyloid-targeting therapies-will be closely monitored. The study seeks to provide a more robust understanding of Lecanemab's impact on disease progression, cognition, and potential adverse effects, contributing to a more informed clinical application of this treatment in Alzheimer's care.
Age: 50 to 90 years old.
No gender restrictions.
Patients with MCI and mild AD.
The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point.
Patients with cognitive impairment caused by reasons other than AD.
There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening.
A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects.
Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study.
Parallel
Lecanemab 10 mg/kg
DrugLecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL. Lecanemab is to be administered via intravenous infusion over 60 minutes in saline solution. Lecanemab must be administered using an infusion system that includes a terminal 0.22 μM inline filter. The dosage of Lecanemab is 10 mg/kg.
Conventional anti-dementia treatment group
DrugConventional anti-dementia treatment: Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment.
Change in Aβ-PET centiloid values
Change in Lecanemab versus Conventional Anti-Dementia Treatment Based on Aβ-PET Centiloid Scores in 18 months
Change of retinal and cerbral imaging
Retinal and cerbral imaging Difference Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Change of MoCA score
Assess the difference in MoCA Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Change of MMSE score
Assess the difference in MMSE Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
Change of CDR score
Assess the difference in CDR Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups
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