Who is eligible for clinical trial NCT06584357?

Participants must meet protocol criteria for Mild Cognitive Impairment. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06584357 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-13

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 (NCT06584357)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: GAP Innovations, PBC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (28 items).

Location: JEM Research Institute — Atlantis, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria: Pre-screening Exclusion Criteria Participants who meet ANY of the following criteria will not be eligible to progress to Visit 1 (Screening):
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;
Participants who have reported or have a known negative amyloid PET scan in the past 6 months;
Participants with any known contraindication to brain MRI scan;
Participants with history of stroke or seizures within 1 year of the Pre-Screening Visit;
Participants with history of cancer within the past 5 years with the exception of non-melanoma skin cancer or prostate cancer in situ;
Participants with known or suspected alcohol or drug abuse or dependence within 1 year of the Pre- Screening Visit;
Participants who report any current unstable psychiatric symptoms that could interfere with study procedures or impact study data (e.g., uncontrolled depression);
Participants who have received any potential disease modifying AD treatment within 6 months prior to the Pre-screening Visit; and
Participants with known history or self-report to be Human Immunodeficiency Virus (HIV) Positive unless controlled by antiviral medication. Core Study Exclusion Criteria Participants who meet ANY of the following criteria, in addition to the Pre-screening Exclusion Criteria, will not be eligible to enroll into the study:
Participants who, in the opinion of the Site Principal Investigator, have serious or unstable medical conditions that would prohibit their completion of all study procedures and data collection;
Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (26 Sites)

JEM Research Institute — Atlantis, Florida
Visionary Investigators Network — Aventura, Florida
K2 - Winter Garden — Clermont, Florida
Brain Matters Research — Delray Beach, Florida
Neuropsychiatric Research Center of SW Florida — Fort Myers, Florida
K2 Medical Research — Maitland, Florida
Clincloud — Melbourne, Florida
Visionary Investigators Network — Miami, Florida
Charter Research — Orlando, Florida
Progressive Medical Research — Port Orange, Florida
Intercoastal Medical Group, Inc. — Sarasota, Florida
Axiom Brain Health — Tampa, Florida
Conquest Research — Winter Park, Florida
Flourish Research - Chicago — Chicago, Illinois
Quest Research Institute — Farmington Hills, Michigan
Clinical Neurology Specialists — Las Vegas, Nevada
ADRC of Albany — Albany, New York
Neuro-Behavioral Clinical Research Inc. — North Canton, Ohio
Flourish Research - Philadelphia — Philadelphia, Pennsylvania
K2 Medical Research — East Providence, Rhode Island
Gadolin Research LLC — Beaumont, Texas
Re:Cognition Health — Houston, Texas
Toronto Memory Program — Toronto, Ontario
NeuroClin Glasgow — Motherwell, North Lanarkshire
Re:Cognition Health — London,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗