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:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT06470061
Eligibility Criteria:
Inclusion Criteria:
* 50-90 years of age at screening.
* Male or female
* Any race or ethnicity.
* Provide written informed consent.
* Availability for the duration of the study.
* Ability to speak, read, and understand English.
* Ability to take oral medication and be willing to adhere to the RQC regimen.
* Have adequate literacy, vision, and hearing for neuropsychological testing at screening
Exclusion Criteria:
* MMSE score 0-25, indicating more than subtle cognitive abnormalities
* CDR-SB score \> 0, indicating functional impairment
* Clinical diagnosis of any non-Alzheimer's disease (AD) type of mild cognitive impairment (MCI) or dementia
* Taking pharmaceutical anti-Aβ monoclonal antibodies (i.e., Leqembi, Aduhelm).
* Participation in another clinical study with an investigational product during the last 90 days.
* Presence of hepatic disease or kidney disease
* Clinically significant or unstable hematologic, cardiovascular, pulmonary, gastrointestinal, endocrine metabolic, or other systemic disease.
* Diagnosis of gastrointestinal or stomach condition including but not limited to irritable bowel syndrome (IBS), ulcerative colitis, peptic ulcers, Crohn's disease, gastroesophageal reflux disease, gastritis, severe dyspepsia, and intestinal malabsorption.
* Clinically significant abnormal values in hematology, coagulation and platelet function, clinical chemistry, or urinalysis at screening (such as those with prolonged prothrombin time (PT), anemia, low neutrophil or platelet count, elevated liver function tests, low glomerular filtration rate).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT06470061
Study Brief:
Protocol Section:
NCT06470061