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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

NCT06584357

This study is recruiting at 19 US sites in 6 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Mild Cognitive Impairment
  • Alzheimer's Disease
  • Alzheimer's Disease, Early Onset
  • Memory Loss
  • Memory Disorders
  • Memory Impairment

Eligibility basics and study details

Study type
Observational
Phase
Not applicable
Ages
60 to 90 years
Sex
All
Healthy volunteers
Accepted
Sponsor
GAP Innovations, PBC
Last updated on ClinicalTrials.gov
April 15, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Florida · 13

  • JEM Research Institute · Atlantis, FL
  • Visionary Investigators Network · Aventura, FL
  • K2 - Winter Garden · Clermont, FL
  • Brain Matters Research · Delray Beach, FL
  • Neuropsychiatric Research Center of SW Florida · Fort Myers, FL
  • K2 Medical Research · Maitland, FL
  • Clincloud · Melbourne, FL
  • Visionary Investigators Network · Miami, FL
  • Charter Research · Orlando, FL
  • Progressive Medical Research · Port Orange, FL
  • Intercoastal Medical Group, Inc. · Sarasota, FL
  • Axiom Brain Health · Tampa, FL
  • Conquest Research · Winter Park, FL

Illinois · 1

  • Flourish Research - Chicago · Chicago, IL

Michigan · 1

  • Quest Research Institute · Farmington Hills, MI

Nevada · 1

  • Clinical Neurology Specialists · Las Vegas, NV

Rhode Island · 1

  • K2 Medical Research · East Providence, RI

Texas · 2

  • Gadolin Research LLC · Beaumont, TX
  • Re:Cognition Health · Houston, TX

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.