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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03451760
Eligibility Criteria:
Inclusion Criteria:
* 55 years old or older.
* Diagnosis of AD, vascular, and mixed dementia
* Neuropsychiatric Inventory Questionnaire (NPI-Q) at least 3 items out of 12 items are rated as "present."
* Use of cholinesterase inhibitors, antidepressants and or antipsychotics medications is allowed, if on stable dosage for at least 2 months.
* Use of memantine and/or serotonin reuptake inhibitors is also allowed, if on stable dose for at least 2 months.
* Have a committed caregiver who is able and willing to assist them with medications, provide study participant information, and attend all study visits.
* Sufficient English language skills to complete all testing.
* MMSE score of 25 or lower.
Exclusion Criteria:
* Participants who started using antipsychotics or anticholinergics within the previous 2 months.
* Participants on blood thinners such as warfarin (Coumadin, jantoven), rivaroxaban (xarelto), fondaparinux (arixtra), dibigatran (pradaxa), apixaban (eliquis) dalteparin (fragmin), enoxaparin (lovenox). Aspirin use is allowed.
* Participants without an identified caregiver.
* Participants with delirium caused by medicinal poisoning or drug intoxication.
* Participants who have had the following diseases before the onset of cognitive impairment:
1. Alcoholism
2. Manic depression or bipolar disorder
3. Schizophrenia
* Participants with malignancy or an acute inflammatory disease.
* Participants with critical circulatory, respiratory, kidney, or liver disease or diabetes.
* BMI of \>30.
* Participants who have taken Feru-guard, ferulic acid, or Angelica archangelica supplementation within the last year.
* Enrollment in another clinical trial or treatment study within the previous 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT03451760
Study Brief:
Protocol Section:
NCT03451760