Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733989
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2020-12-28
Brief Title:
A Biomarker Database to Investigate Blood-Based and Digital Biomarkers in Participants Screened for Alzheimers Disease Bio-Hermes
Sponsor:
GAP Innovations PBC
Organization:
GAP Innovations PBC
Study Overview
Official Title:
Development of a Biomarker Database to Investigate Aß P-tau and NfL Blood-Based Biomarkers and Digital Biomarkers in Older Participants Screened for Preclinical Alzheimers Disease AD Prodromal AD or Mild AD
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 1000 volunteers over the age of 60 screened for Preclinical Alzheimers Disease Prodromal AD or Mild Dementia AD and includes an endpoint enrollment requirement of 200 participants from underrepresented minority populations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None