Alzheimers disease
Conditions
Interventions
Combination therapy cohort (treated with lecanemumab combined with Lisi's transdermal patch):None
Monotherapy cohort (receiving only conventional treatment with lecanemumab):None
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 50 to 90 years (inclusive); 2. Confirmed diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria, with evidence of amyloid beta (Aß) pathology; 3. Prior to enrollment, a clinical decision has already been made according to routine clinical practice to treat the patient with lecanemab (monotherapy cohort) or lecanemab in combination with the rivastigmine transdermal patch (combination therapy cohort); 4. The patient or their legally authorized representative is able to understand and voluntarily sign the written informed consent form (ICF); 5. The patient has a consistent and reliable caregiver who is able to accompany them to study visits and provide relevant information.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of mixed dementia (e.g., AD combined with vascular dementia), or cognitive impairment caused by other neurodegenerative diseases (e.g., frontotemporal dementia, dementia with Lewy bodies, Parkinson's disease dementia); 2. Known hypersensitivity (allergy) to lecanemab, rivastigmine, or any of their excipients; 3. History of severe asthma or severe arrhythmia (e.g., sick sinus syndrome, severe sinus bradycardia, second- or third-degree atrioventricular block); 4. Currently participating in any interventional clinical trial (including drugs, devices, or biologics); 5. Any medical, psychological, or social condition that, in the judgment of the investigator, may affect study compliance, data collection, or patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in ADAS-cog score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Neuropsychiatric Inventory score;Treatment compliance score (based on patch usage records);Incidence of adverse events and serious adverse events;Caregiver burden assessment;Change from baseline in MMSE/MoCA scores;Change from baseline in ADCS-ADL (Activities of Daily Living) score; | — |
Countries
China
Contacts
Public ContactYe Qinyong
Fujian Medical University Union Hospital
Outcome results
None listed