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

Last updated: May 16, 2025
Sponsor: GAP Innovations, PBC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Alzheimer's Disease

Learning Disorders

Treatment

Biomarker Data Collection

MK6240

Clinical Study ID

NCT06584357
Bio-Hermes-002
  • Ages 60-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

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 theparticipant (defined as at least 8 hours of contact a week) and is able to provideaccurate 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 localand national guidance and regulation;

  2. Participants must be willing to undergo an MRI brain scan within 90 days and anamyloid 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 theinformed consent, including blood sampling, genetic testing, and storage ofbiospecimens 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 clinicalresearch trials once their participation in this study ends; and

  6. Participants must have a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusiveat screening.

Exclusion

Exclusion Criteria:

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-reportedpregnancy, sensitivity to ligands being used, poor venous access, contraindicationto PET, or planned or recent exposure to ionizing radiation that in combination withthe planned administration of amyloid radioligand would result in a cumulativeexposure 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-ScreeningVisit;

  5. Participants with history of cancer within the past 5 years with the exception ofnon-melanoma skin cancer or prostate cancer in situ;

  6. Participants with known or suspected alcohol or drug abuse or dependence within 1year of the Pre- Screening Visit;

  7. Participants who report any current unstable psychiatric symptoms that couldinterfere with study procedures or impact study data (e.g., uncontrolleddepression);

  8. Participants who have received any potential disease modifying AD treatment within 6months 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.

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:

  1. Participants who, in the opinion of the Site Principal Investigator, have serious orunstable medical conditions that would prohibit their completion of all studyprocedures and data collection;

  2. Participants who have serious or unstable medical conditions that would likelypreclude their participation in an interventional research trial;

  3. Participants with self-reported, untreated conditions such as vitamin B12 or folatedeficiency or bladder infections that in the opinion of the Site PrincipalInvestigator could contribute to cognitive impairment;

  4. Participants who have completed cognitive testing within 1 month of Visit 1 (Screening) where the Site Principal Investigator believes the participant'sexposure may cause practice effect;

  5. Participants who have any neurological disorder affecting the central nervoussystem, other than AD, that may be contributing to cognitive impairment (e.g.,Parkinson's disease, other dementias, multiple concussions or seizures) as deemedsignificant by the Site Principal Investigator;

  6. Participants with a Geriatric Depression Scale (GDS) score greater than or equal to 8 at Visit 1 (Screening) and is deemed to be clinically significantly depressed bythe Site Principal Investigator;

  7. Participants with a Rey Auditory Verbal Learning Test (RAVLT) t-score of ≥ 1.2standard deviation above the mean. For non-African Americans, calculateage-sex-education adjusted t-scores. For African American participants, use theMOANS to calculate the age-education adjusted t-scores;

  8. Participants weighing less than 110 pounds;

  9. Participants who are direct employees or family members of direct employees of theparticipating investigators' sites;

  10. Participants who are direct employees of the Sponsor;

  11. Participants who, in the opinion of the investigator, are unable to completecognitive testing due to inadequate visual or auditory acuity; and

  12. For participants completing the RetiSpec retinal scan: Those with a known history ofcontraindication or allergy to Tropicamide 1% (pupil dilation drop).

Longitudinal Sub-Study Eligibility

Inclusion Criteria:

Participants must meet ALL of the following criteria for entry into the sub-study:

  1. Participants who completed the Bio-Hermes-002 Core Study;

  2. Are willing to complete phone call visits with site staff every three months andreturn to the clinic for an annual evaluation; and

  3. Are willing to complete annual PET scans for both amyloid and tau scans.

Exclusion Criteria:

Participants who meet ANY of the following criteria will not be eligible for entry into the sub-study:

  1. Those who are enrolled or intend to enroll into a clinical trial for Alzheimer'sdisease with a potential disease-modifying intervention;

  2. Participants who have serious or unstable medical conditions that would likelypreclude their participation in an interventional research trial;

  3. Those who intend to use medications outside clinical research studies approved byregulatory authorities to modify Alzheimer's disease pathology.

Study Design

Total Participants: 1200
Treatment Group(s): 2
Primary Treatment: Biomarker Data Collection
Phase:
Study Start date:
September 26, 2024
Estimated Completion Date:
July 31, 2028

Connect with a study center

  • JEM Research Institute

    Atlantis, Florida 33462
    United States

    Active - Recruiting

  • Visionary Investigators Network

    Aventura, Florida 33180
    United States

    Active - Recruiting

  • K2 - Winter Garden

    Clermont, Florida 34711
    United States

    Active - Recruiting

  • Brain Matters Research

    Delray Beach, Florida 33445
    United States

    Active - Recruiting

  • Neuropsychiatric Research Center of SW Florida

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Active - Recruiting

  • Clincloud

    Melbourne, Florida 32940
    United States

    Active - Recruiting

  • Visionary Investigators Network

    Miami, Florida 33133
    United States

    Active - Recruiting

  • Charter Research

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Progressive Medical Research

    Port Orange, Florida 32127
    United States

    Active - Recruiting

  • Intercoastal Medical Group, Inc.

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Axiom Brain Health

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Flourish Research - Chicago

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • ADRC of Albany

    Albany, New York 12208
    United States

    Active - Recruiting

  • Neuro-Behavioral Clinical Research Inc.

    North Canton, Ohio 44720
    United States

    Active - Recruiting

  • Flourish Research - Philadelphia

    Philadelphia, Pennsylvania 19462
    United States

    Active - Recruiting

  • Gadolin Research LLC

    Beaumont, Texas 77702
    United States

    Active - Recruiting

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