Trials / Completed
CompletedNCT04733989
A Biomarker Database to Investigate Blood-Based and Digital Biomarkers in Participants Screened for Alzheimer's Disease (Bio-Hermes)
Development of a Biomarker Database to Investigate Aß, P-tau, and NfL Blood-Based Biomarkers and Digital Biomarkers in Older Participants Screened for Preclinical Alzheimer's Disease (AD), Prodromal AD, or Mild AD
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,002 (actual)
- Sponsor
- GAP Innovations, PBC · Industry
- Sex
- All
- Age
- 60 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study (Bio-Hermes) is to develop a blood, digital, and brain amyloid PET scan biomarker database that can be used to determine whether a meaningful relationship exists between digital tests, blood amyloid-beta, p-tau, and neurofilament biomarker levels and amyloid-beta levels identified through brain amyloid PET images. Blood collected will also be genetically sequenced to gain insights about genes and brain amyloid. The Bio-Hermes study will include 1,000 volunteers over the age of 60 screened for Preclinical Alzheimer's Disease, Prodromal AD, or Mild Dementia AD, and includes an endpoint enrollment requirement of 200 participants from underrepresented minority populations.
Conditions
- Alzheimer Disease
- Alzheimer Disease, Early Onset
- Mild Cognitive Impairment
- 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 Alzheimer's disease. Some of the samples will be stored for future analysis. |
Timeline
- Start date
- 2021-04-21
- Primary completion
- 2022-11-11
- Completion
- 2022-11-11
- First posted
- 2021-02-02
- Last updated
- 2023-02-09
Locations
16 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04733989. Inclusion in this directory is not an endorsement.