ClinicaliQ Trial Snapshot
- 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 — Recruiting • Respiratory /….
- Sponsor: GAP Innovations, PBC.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : 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;
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.