alzheimer's disease
Conditions
Interventions
Lecanemab treatment Group:None
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meets the core clinical criteria for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild AD dementia as defined by the National Institute on Aging–Alzheimer’s Association (NIA-AA); 2. Demonstrates cognitive decline and satisfies the following clinical criteria: (a) Mini-Mental State Examination (MMSE) score of 20 or higher; and (b) Clinical Dementia Rating–Global Score (CDR-GS) of 0.5 or 1; 3. Meets the prescribing criteria for lecanemab (as specified in the lecanemab drug label); 4. Is willing and able to fulfill all study requirements, including MRI scans, neuropsychological assessments, and clinical genotyping; 5. Has a reliable caregiver or family member who can objectively complete clinical evaluations such as the CDR, quality-of-life questionnaires, and activities of daily living assessments; 6. Is capable of providing informed consent, fully understands the study, and is willing and able to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of allergy to lecanemab or any of its excipients; 2. Subjects with significant neurological diseases other than AD that could affect cognition or the ability to complete the study, including but not limited to other types of dementia, severe brain infections, Parkinson's disease, multiple concussions, epilepsy, or recurrent seizure episodes; 3. Subjects with current serious or unstable medical conditions, including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological (except AD), psychiatric, immunological, or hematological disorders, as well as other conditions that the investigator believes may impact the analysis results of this study; or life expectancy 3 or documented history of post-stroke sequelae); 6. Severe liver or renal insufficiency at diagnosis; 7. Unstable or clinically significant cardiovascular diseases such as myocardial infarction; 8. Previously diagnosed or currently known untreated HIV infection, hepatitis B or C infection, or history of CNS spirochetal infections (e.g., syphilis, Lyme disease, or Borrelia burgdorferi infection) considered inadequately treated by the investigator; participants with significant systemic immunosuppression due to the ongoing effects of immunosuppressive drugs; 9. Unable to tolerate MRI scans or have contraindications to MRI, including but not limited to: implanted pacemakers incompatible with MRI, aneurysm clips, artificial heart valves, ear implants, or foreign metal implants that are prohibited during MRI scanning, or other clinical histories or examination results that the investigator deems potentially harmful for MRI procedures.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| HRQoL;Ptau217;Tau PET; | — |
Primary
| Measure | Time frame |
|---|---|
| CDR-SB; | — |
Countries
China
Contacts
Public ContactJintai Yu
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed