RecruitingMild Cognitive ImpairmentAlzheimer's DiseaseAlzheimer's Disease, Early Onset

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

Eligible age

60–90 yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

Yes

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About this study

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.

Sponsor: GAP Innovations, PBC

You may qualify if…

✓ Pre-screening Inclusion Criteria
✓ Participants must meet ALL of the following criteria to progress to Visit 1 (Screening):
✓ 1. Participant is between 60 to 90 years of age (inclusive) at the time of consent; and
✓ 2. 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:
✓ 1. 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;
✓ 2. 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;

You may not qualify if…

✕ Pre-screening Exclusion Criteria
✕ Participants who meet ANY of the following criteria will not be eligible to progress to Visit 1 (Screening):
✕ 1. Participant is unable to undergo amyloid and tau PET scans due to self-reported pregnancy, sensitivity to ligands being used, poor venous access, contraindication to PET, or planned or recent exposure to ionizing radiation that in combination with the planned administration of amyloid radioligand would result in a cumulative exposure that exceeds recommended local guidelines;
✕ 2. Participants who have reported or have a known negative amyloid PET scan in the past 6 months;
✕ 3. Participants with any known contraindication to brain MRI scan;
✕ 4. Participants with history of stroke or seizures within 1 year of the Pre-Screening Visit;
✕ 5. Participants with history of cancer within the past 5 years with the exception of non-melanoma skin cancer or prostate cancer in situ;
✕ 6. Participants with known or suspected alcohol or drug abuse or dependence within 1 year of the Pre- Screening Visit;