NCT07152418 · NOT YET RECRUITING
Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
This trial is testing lecanemab, an anti-amyloid antibody drug already approved in some countries, against standard dementia care. The focus is on using PET brain scans to track amyloid and tau protein buildup and figure out which patients benefit most from the drug. The phase is unspecified, so this appears to be an observational and comparative study rather than a standard Phase 1-3 efficacy trial.
You may qualify if
- Meet the diagnostic criteria for Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or mild-to-moderate AD. [Clinical Scores: CDR Global Score = 0.5 (for MCI) or 1 (for mild AD), corresponding to clinical stages 3-4, with a positive PIB-PET scan confirming amyloid pathology]
- Male or Female
- Between 50 and 85 years old (inclusive)
- Not currently participating in any other clinical trial or research study
- Participants must provide informed consent for this trial prior to enrollment and must voluntarily sign a written informed consent form
- Participants must be able to communicate effectively with the investigator and are expected to comply with the study requirements to completion
You're excluded if
- Any contraindication to MRI
- History of seizure within the past 6 months or refractory epilepsy.
- Unstable or severe psychiatric illness within the past 6 months.
- History of bleeding disorders, coagulopathy, or clinically significant coagulation abnormalities (e.g., platelet count \<50,000/μL or INR >1.5).
- Uncontrolled diabetes mellitus or hypertension.
- History of unstable angina, myocardial infarction, advanced heart failure, or clinically significant conduction abnormalities within the past year.
- Active cancer treatment (e.g., chemotherapy, biologics, or radiation therapy), except maintenance therapy for cancers in remission (e.g., anti-estrogen therapy for breast cancer).
- Immunological disorders requiring ongoing immunosuppression, immunoglobulin therapy, monoclonal antibodies, or plasmapheresis.
- Breastfeeding individuals or women of childbearing potential not using highly effective contraception.
- History of severe allergic, anaphylactic reactions, or hypersensitivity to any inactive ingredients.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-09-03