Lecanemab for Early-to-Moderate Alzheimer's Disease
Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs
Recruiting
Phase 4Interventional Study
Alzheimer s DiseaseAlzheimer Dementia (AD)MCI-AD, Early Stage Alzheimer's Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 90
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
First Affiliated Hospital of Wenzhou Medical University · Other
Who this trial is looking for
This trial is looking for people with early-to-moderate Alzheimer's Disease. Participants will receive the treatment Lecanemab and be monitored for 24 months with regular evaluations.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 50 and 90 years old.
I have been diagnosed with mild Alzheimer's Disease or MCI.
I have a reliable caregiver to assist me during visits.
I agree to participate and sign the consent form.
I have a positive amyloid test.
My MMSE score is 20 or higher.
My CDR score is 0.5 or 1.
You may not be able to join if
I have cognitive impairment from causes other than Alzheimer's Disease.
I had a stroke or seizure in the last 12 months.
I had severe depression or suicidal behavior in the last 6 months.
I have a history of certain serious health conditions or diseases.
I am allergic to Lecanemab or any of its components.
I have metal implants that prevent me from having an MRI.
I have drug or alcohol abuse issues in the last 2 years.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 integra…
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.
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Eligibility Criteria
Inclusion Criteria:
* 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.
* Positive Amyloid protein confirmed by amyloid-PET or CSF.
* There is a reliable caregiver accompanying the patient during…
Inclusion Criteria:
* 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.
* Positive Amyloid protein confirmed by amyloid-PET or CSF.
* There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial.
* Agree to participate in the research and sign the informed consent form.
Exclusion Criteria:
* 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.
* There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment.
* There are contraindications for MRI scans, including the installation of cardiac pacemakers/defibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans).
* There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening.
* Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group.
* Surgical operations under general anesthesia are planned to be performed during the research period.
* Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.
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