Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia
Bio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective. Digital biomarkers and blood-based biomarkers will be tested to determine whether a meaningful relationship exists between biomarkers alone or in combination with tau or amyloid brain pathology identified through PET images.
⁃ Pre-screening Inclusion Criteria
⁃ Participants must meet ALL of the following criteria to progress to Visit 1 (Screening):
• Participant is between 60 to 90 years of age (inclusive) at the time of consent; and
• Participant has a study partner who has sufficient and frequent contact with the participant (defined as at least 8 hours of contact a week) and is able to provide accurate information regarding the participant's cognitive and functional abilities.
⁃ Core Study Inclusion Criteria
⁃ Participants must meet ALL of the following criteria, in addition to the Pre-screening Inclusion Criteria, for entry into the study:
• Participants must provide written consent in the IRB-approved or Ethics Committee (EC) approved informed consent form or have a legally authorized representative (LAR) provide written consent on the participant's behalf in accordance with local and national guidance and regulation;
• Participants must be willing to undergo an MRI brain scan within 90 days and an amyloid and tau PET scan within 120 days of signing informed consent;
• Participants must be willing to comply with all study procedures as outlined in the informed consent, including blood sampling, genetic testing, and storage of biospecimens for future research;
• Fluency in the language of the tests used at the study site;
• Participants must be willing to be contacted for possible participation in clinical research trials once their participation in this study ends; and
• Participants must have a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusive at screening.
⁃ Participants must meet ALL of the following criteria for entry into the sub-study:
• Participants who completed the Bio-Hermes-002 Core Study;
• Are willing to complete phone call visits with site staff every three months and return to the clinic for an annual evaluation; and
• Are willing to complete annual PET scans for both amyloid and tau scans.