Trials / Recruiting
RecruitingNCT06584357
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,200 (estimated)
- Sponsor
- GAP Innovations, PBC · Industry
- Sex
- All
- Age
- 60 Years – 90 Years
- Healthy volunteers
- Accepted
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
- Mild Cognitive Impairment
- Alzheimer's Disease
- Alzheimer's Disease, Early Onset
- Memory Loss
- Memory Disorders
- Memory Impairment
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Biomarker Data Collection | 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. |
| RADIATION | MK6240 | 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. |
Timeline
- Start date
- 2024-09-26
- Primary completion
- 2028-07-01
- Completion
- 2028-07-01
- First posted
- 2024-09-04
- Last updated
- 2026-04-15
Locations
26 sites across 3 countries: United States, Canada, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06584357. Inclusion in this directory is not an endorsement.