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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

60 Years - 90 Years

Healthy Volunteers

Accepted

Interventions

• Biomarker Data Collection — OTHER
  During this study, a sample of your blood will be collected and you will have a PET scan taken of your brain. Blood sample results will be compared to PET scan pictures to understand how well the markers in the blood predict whether there is amyloid in the brain. Blood samples will also be collected that contain your genes. These genetic samples will also be compared to PET scans to help researchers understand how different people react to medicines and to understand the genetic causes of AD. Some of the samples will be stored for future analysis.
• MK6240 — RADIATION
  Each participant will be assessed using either one of two radioactive tau PET tracers: Flortaucipir or MK6240. Flortaucipir is FDA approved while MK6240 is not and is being used in this study as an investigational radioactive drug.

Study Details

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.

Key Dates

Start date

Sep 26, 2024

Status verified

Apr 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

1,200 participants (estimated)

Arms

• Arm: Cognitively Normal
  No reported memory loss or concerns as reported by participant and study partner.
• Arm: Mild Cognitive Impairment
  A diagnosis of Mild Cognitive Impairment (MCI) based on the National Institute of Aging (NIA) criteria and verified through medical records.
• Arm: Mild-to-Moderate AD Dementia
  A diagnosis of Mild-to-Moderate AD Dementia based on the National Institute of Aging (NIA) criteria and verified through medical records.

Primary Outcome Measure

Biomarkers and PET [ Time Frame: Through study completion, an average of 3 years ]

Central Contacts

• Amanda Ng, MA
  biohermes-002@globalalzplatfor
  [email protected]

Locations (22)

Find similar trials in Atlantis, FL

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