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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07459959
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Alzheimer's disease confirmed by biomarkers (imaging or biofluid evidence of amyloid-beta and tau pathology)
* Mild stage of Alzheimer's disease: Clinical Dementia Rating (CDR) ≤ 1 or Quick Dementia Rating System (QDRS) ≤ 8
* Medically stable and able to attend study visits and complete study procedures
* On stable doses of any psychotropic medications for at least 4 weeks before the baseline visit
* Not currently receiving anti-amyloid monoclonal antibody therapy
Exclusion Criteria:
* New or unstable neurological disorder or unstable psychiatric illness that could affect safety or study results
* Clinically significant kidney or thyroid problems that pose safety concerns, or abnormal safety labs judged to be related to study drug and requiring discontinuation
* Use of thiazide diuretics during the dosing period (unless stopped at least 4 weeks before baseline)
* Chronic daily use of non-aspirin NSAIDs (including COX-2 inhibitors); short courses require study team approval and may require temporary study drug hold and safety labs before resuming
* Starting excluded therapies during the active treatment period (e.g., anti-amyloid monoclonal antibody treatment)
* Noncompliance with essential study procedures that would prevent collection of primary safety or feasibility endpoints (e.g., repeated missed visits or refusal of critical labs)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07459959
Study Brief:
Protocol Section:
NCT07459959