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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT05892627
Eligibility Criteria:
Inclusion Criteria:
* Subjects over 50 years of age
* Subjects with Mini-Mental State Exam (MMSE) of 25-30 inclusive (global cognitive function)
* Subjects who are able to undergo EEG and to commit to visits to WARU/P5.
* Subjects who are able to provide venous blood samples.
* Subjects able to provide written informed consent PRIOR to performing any study procedures.
Exclusion Criteria:
* Subjects with diagnosis of Alzheimer's disease or other dementia
* Subjects taking medication for the treatment of dementia (such as acetylcholinesterase inhibitors (Aricept, Excelon), memantine (Namenda) or other medications with similar mechanisms of action) or medical foods (such as Cerefolin, Souvenaid, Axona) for the treatment of dementia.
* Subjects who are already regularly taking probiotics, post-biotics, nutraceutical and/or vitamin supplements related to PoZibio ™ within 30 days of screening.
* Subjects with Geriatric Depression Scale \> 6
* Subjects with a Mini Mental State Exam score below 25
* Subjects who are pregnant or lactating
* Subjects with medical condition or disease that is life threatening
* Subjects who smoke cigarettes or use other products containing nicotine.
* Subjects diagnosed with diabetes.
* Subjects taking warfarin.
* Subjects who identify as being vegetarian or vegan
* Subjects who have a diagnosed or suspected mental health condition, or who have any concerns surrounding their mental health
* Subjects who have immediate family members with diagnosed mental health condition or suspected mental health concerns
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05892627
Study Brief:
Protocol Section:
NCT05892627