Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT07152418
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT07152418
Study Brief:
Protocol Section:
NCT07152418