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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: Recruiting study of Mild Cognitive Impairment and Alzheimers Disease, sponsored by GAP Innovations, PBC.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Measure blood biomarkers (Aβ 42/40, p-tau 181, p-tau 217, p-tau 231, total tau, and NFL) to see if it will predict the extent of tau and amyloid brain pathology as measured by PET brain imaging in participants shown to be cognitively normal (CN), have mild cognitive impairment (MCI), or have mild-to-moderate AD dementia.

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
GAP Innovations, PBC

2 total trials

What NCT06584357 shows while recruiting

NCT06584357 is an observational study that tracks outcomes without assigning an intervention. Its 1,200 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,265-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target.

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 names 20 study sites across 8 states, led by 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.

Learn More About Clinical Trials

Similar trials for Mild Cognitive Impairment

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06584357's enrollment target sits among peer trials

1,200 12th of 205 higher than 194 of 205 other Mild Cognitive Impairment trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06584357

Source: ClinicalTrials.gov NCT06584357, the US trial registry maintained by the National Library of Medicine. NCT06584357 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.