MedTrace Logo

A Biomarker Database to Investigate Blood-Based and Digital Biomarkers in Participants Screened for Alzheimer's Disease (Bio-Hermes)

NCT04733989 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1002

Last updated 2023-02-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • GAP Innovations, PBC

    lead INDUSTRY

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2022-11-11
Completion
2022-11-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04733989 on ClinicalTrials.gov