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RECRUITING

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•GAP Innovations, PBC

Summary

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

Age

60 - 90 years

Sex

ALL

Healthy Volunteers

Yes

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.
•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;
•3. 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;
•4. Fluency in the language of the tests used at the study site;
•5. Participants must be willing to be contacted for possible participation in clinical research trials once their participation in this study ends; and
•6. 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:
+3 more criteria

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;
•7. Participants who report any current unstable psychiatric symptoms that could interfere with study procedures or impact study data (e.g., uncontrolled depression);
•8. Participants who have received any potential disease modifying AD treatment within 6 months prior to the Pre-screening Visit; and
•9. Participants with known history or self-report to be Human Immunodeficiency Virus (HIV) Positive unless controlled by antiviral medication.
+17 more criteria

Locations (25)

JEM Research Institute

Atlantis, Florida, United States

Visionary Investigators Network

Aventura, Florida, United States

K2 - Winter Garden

Clermont, Florida, United States

Brain Matters Research

Delray Beach, Florida, United States

Neuropsychiatric Research Center of SW Florida

Fort Myers, Florida, United States

K2 Medical Research

Maitland, Florida, United States

Clincloud

Melbourne, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

Charter Research

Orlando, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Key Dates

Start Date

September 26, 2024

Primary Completion Date

July 1, 2028

Completion Date

July 1, 2028

Last Updated

February 11, 2026

Enrollment

1,200

ESTIMATED participants

Conditions

Mild Cognitive ImpairmentAlzheimer's DiseaseAlzheimer's Disease, Early OnsetMemory LossMemory DisordersMemory Impairment

Interventions

Biomarker Data Collection

OTHER

MK6240

RADIATION

Contacts

Amanda Ng, MA

CONTACT

biohermes-002@globalalzplatfor biohermes-002@globalalzplatform.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Sense4Safety Intervention

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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