Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 · View on ClinicalTrials.gov ↗

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.

Interventions

  • OTHER Biomarker Data Collection
  • RADIATION MK6240

Study Locations (20)

Florida

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

Illinois

  • Flourish Research - Chicago — Chicago

Michigan

  • Quest Research Institute — Farmington Hills

Nevada

  • Clinical Neurology Specialists — Las Vegas

New York

  • ADRC of Albany — Albany

Ohio

  • Neuro-Behavioral Clinical Research Inc. — North Canton

Pennsylvania

  • Flourish Research - Philadelphia — Philadelphia

Rhode Island

  • K2 Medical Research — East Providence

Trial Details

FieldValue
Enrollment Target 1,200 participants
Start Date 2024-09-26
Est. Completion 2028-07

Sponsor

GAP Innovations, PBC

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06584357

The ClinicalTrials.gov registry entry for NCT06584357 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GAP Innovations, PBC, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions — of which Biomarker Data Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06584357 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, Illinois, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06584357 about?

NCT06584357 is a clinical study titled "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 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 rela...

What is the current status of trial NCT06584357?

This trial is currently recruiting. The enrollment target is 1,200 participants. The study started on 2024-09-26. Estimated completion is 2028-07.

What conditions does trial NCT06584357 study?

This clinical trial studies the following conditions: Mild Cognitive Impairment, Alzheimer's Disease, Memory Impairment, Memory Loss, Memory Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06584357?

The interventions under investigation include: Biomarker Data Collection (OTHER), MK6240 (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06584357?

This trial is sponsored by GAP Innovations, PBC, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06584357 being conducted?

This trial has 20 study locations across Florida, Illinois, Michigan, Nevada, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial