Lecanemab to boost synaptic plasticity in early Alzheimer's disease

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

This study will test whether lecanemab can preserve synaptic function and slow cognitive decline in amyloid-positive people aged 50–90 with mild cognitive impairment or mild Alzheimer's disease.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Drugs / interventions: ranucimab, lencanemab, Lecanemab, lencanumab, luncanemab
• Locations: 1 site (Beijing)
• Trial ID: NCT06871839 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People aged 50–90 with MCI or mild Alzheimer's disease, MMSE ≥20, CDR 0.5–1, amyloid-positive on PET or CSF, and a reliable caregiver are ideal candidates.

Not a fit: Patients without amyloid pathology, with moderate-to-severe AD, recent stroke or seizure, significant uncontrolled psychiatric illness, or bleeding disorders are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, lecanemab could slow cognitive decline by improving synaptic plasticity and delaying progression in early Alzheimer's disease.

How similar studies have performed: Large global phase III trials, including data from China, have shown that lecanemab can slow cognitive decline in MCI and mild AD over 18 months, though the precise synaptic mechanisms are not fully understood.

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.

Where this trial is running

Beijing

• 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

Conditions Alzheimer' s Disease; Lecanemab; Functional Magnetic Resonance Imaging; s disease; functional magnetic resonance imaging