Lecanemab to boost synaptic plasticity in early Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls amyloid-positive participants aged 50–90 with MCI or mild AD and compares those receiving lecanemab with those on conventional anti-dementia therapy. Participants will undergo functional MRI to measure synaptic plasticity alongside standard cognitive and clinical scales (for example, MMSE and CDR) while caregivers help supervise treatment and visits. The aim is to link lecanemab-associated amyloid clearance to changes in brain synaptic function and clinical outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Capital Medical University Xuanwu Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Cui bai Wei — Xuan Wu Hospital of Capital Medical University
• Study coordinator: Cui bai Wei
• Email: weicb@xwhosp.org
• Phone: 83198319

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.