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)

NCT06584357 RECRUITING

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.

Details

Lead sponsor	GAP Innovations, PBC
Status	RECRUITING
Enrolment	1200
Start date	2024-09-26
Completion	2028-07

Conditions

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

Interventions

• Biomarker Data Collection
• MK6240

Primary outcomes

• Biomarkers and PET — Through study completion, an average of 3 years
  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.

Countries

United States, Canada, United Kingdom