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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT05984056
Eligibility Criteria:
Inclusion Criteria:
1. Participants must be enrolled in Cleveland Clinic Brain Study (CCBS). CCBS is a prospective non-interventional study platform for the hyper characterization of the brain and body systems changes (blood, cardio-vascular, voice, visual, cognitive, digestive, brain structure, and neurophysiology) in neurologically healthy individuals 50 years and older. All individuals undergo periodic and thorough neurological assessments, blood tests, and cardiac, neurocognitive, imaging, vision, and neurophysiological testing.
2. CCBS participants who do not have a clinical neurological disease (except headache) but show signs of being at risk of developing one of the four conditions based on the below criteria:
* Stroke: MRI changes consistent with moderate-severe white matter disease on Fazekas Scale
* Epilepsy: Spikes/Poylspikes/ Sharp Waves on EEG
* Movement Disorder: Hyposmia on U. Penn Smell Identification Test (UPSIT \<10 percentile based on age)
* Dementia: Auditory Verbal Learning Test (AVLT) Trial 1-5 total or Trial 7 scoring \<=1.5 SD and subjective memory on BACH score (proprietary test) 0-40
Exclusion Criteria:
1. Participants who are actively (at the time of enrollment) engaged in 2 or more of the study interventions.
2. Participants with a diagnosed, symptomatic, chronic illness (i.e., significant psychiatric concerns, liver, gastrointestinal, respiratory, renal, cardiac, etc.) who, based on primary investigator review, cannot safely or effectively participate in the study.
3. Participants undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that, in an investigator's opinion, would impact study participation.
4. Participants who are currently pregnant or less than six weeks postpartum
5. Participants with significant hearing loss
6. Participants with severe impairment of vision/ blindness
7. Participants who require a legally authorized representative (LAR) or lack the capacity to consent for themselves
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT05984056
Study Brief:
Protocol Section:
NCT05984056