The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease

Launched by CUIBAI WEI，CLINICAL PROFESSOR · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called lencanemab for people with early Alzheimer's disease (AD). Alzheimer's is a condition that affects memory and daily activities, and it can be particularly challenging for older adults and their families. The trial aims to understand how lencanemab works in the brain to improve memory and thinking skills by targeting harmful proteins that build up in the brains of people with Alzheimer's. Researchers will use advanced imaging techniques and other assessments to see how well the treatment works and how it affects brain function.

To participate in this study, you must be between 50 and 90 years old and have been diagnosed with mild cognitive impairment or mild Alzheimer's. You will need to have a reliable caregiver who can help you during the study visits. Participants will receive lencanemab infusions or standard dementia treatments, and they will be closely monitored throughout the trial. This study is currently not recruiting participants, but it is an important step in finding new ways to help those living with Alzheimer's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 50 and 90 years.
• • 2. Male or female patients.
• • 3. Patients with MCI and mild AD.
• • 4. MMSE score ≥20, CDR overall score of 0.5 or 1.
• • 5. Amyloid-positive confirmed by Amyloid-PET or CSF.
• • 6. Have a reliable caregiver to accompany the patient during study visits and supervise the use of study medication during the trial.
• • 7. Agree to participate in the study and sign the informed consent form.
• Exclusion Criteria:
• • 1. Patients with cognitive impairment due to reasons other than AD.
• • 2. A history of transient ischemic attack (TIA), stroke, cerebral hemorrhage, or seizure within the 12 months prior to screening.
• • 3. A score of \>17 on the Hamilton Depression Scale at screening, or any suicidal behavior within 6 months prior to screening, at screening, or at the baseline visit, as well as any psychiatric diagnosis or symptoms that interfere with the study procedure (such as hallucinations, anxiety disorder, or paranoia).
• • 4. Patients with a bleeding disorder or receiving anticoagulant therapy, as well as any with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine, and cardiovascular system diseases that affect this study.
• • 5. A hypersensitivity reaction to ranucimab or any other ingredient in the injection solution, or to any monoclonal antibody treatment.
• • 6. Contraindications to MRI scanning, including those with a pacemaker/defibrillator or ferromagnetic metal implants (except for skull and cardiac devices approved as safe for MRI scanning).
• • 7. A known or suspected history of drug or alcohol abuse or dependence within the 2 years prior to screening.
• • 8. Participation in a clinical study involving any therapeutic monoclonal antibody or novel compounds for the treatment of AD within the 6 months prior to screening, unless it can be proven that the subject was in the placebo treatment group.
• • 9. Planning to undergo surgery requiring general anesthesia during the study period.
• • 10. A positive pregnancy test result, lactation, or pregnancy in females at screening or baseline.