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NCT06584357 · ClinicalTrials.gov registry record

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

A clinical trial of Mild Cognitive Impairment and Alzheimers Disease, sponsored by GAP Innovations, PBC.

Recruiting
Registry status
1,200
Enrollment target
20
Study locations

NCT06584357 is a study of Mild Cognitive Impairment and Alzheimers Disease that is actively recruiting participants, run by GAP Innovations, PBC. The registered enrollment target is 1,200 participants, roughly in line with the 1,265-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target. The trial reports 20 study locations across 8 states.

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The verdict

NCT06584357, a study of Mild Cognitive Impairment and Alzheimers Disease, is actively recruiting participants, sponsored by GAP Innovations, PBC.

RECRUITING
Registry status
1,200 participants
Enrollment target
20
Study locations

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.

Conditions Studied

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

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

2 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, categorized as an unspecified phase. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 1,265-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target. The listed sponsor is GAP Innovations, PBC, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT06584357 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, Illinois, Michigan.

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, Alzheimers Disease, Memory Impairment, Memory Loss, Memory Disorders.

What interventions are being tested in trial NCT06584357?

The interventions under investigation include: Biomarker Data Collection (OTHER), MK6240 (RADIATION).

Who is sponsoring clinical trial NCT06584357?

This trial is sponsored by GAP Innovations, PBC, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.