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 (Bio-Hermes-002)

  • STATUS
    Recruiting
  • End date
    Jul 24, 2028
  • participants needed
    1200
  • sponsor
    GAP Innovations, PBC
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Updated on 24 January 2025
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Accepts healthy volunteers

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.

Details
Condition Mild Cognitive Impairment, Alzheimer's Disease, Alzheimer's Disease, Early Onset, Memory Loss, Memory Disorders, Memory Impairment
Age 60years - 90years
Clinical Study IdentifierNCT06584357
SponsorGAP Innovations, PBC
Last Modified on24 January 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participants must meet ALL of the following criteria for entry into the sub-
study
Participants who completed the Bio-Hermes-002 Core Study
Are willing to complete phone call visits with site staff every three months and return to the clinic for an annual evaluation; and
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
Those who are enrolled or intend to enroll into a clinical trial for Alzheimer's disease with a potential disease-modifying intervention
Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial
Those who intend to use medications outside clinical research studies approved by regulatory authorities to modify Alzheimer's disease pathology
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