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

February 7, 2023 updated by: GAP Innovations, PBC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1002

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Aventura, Florida, United States, 33180
        • Visionary Investigators Network - Aventura
      • Coral Gables, Florida, United States, 33133
        • Visionary Investigators Network - Coral Gables
      • Lady Lake, Florida, United States, 32159
        • Charter Research - Lady Lake
      • Lake Worth, Florida, United States, 33462
        • JEM
      • Maitland, Florida, United States, 32751
        • ClinCloud
      • Miami, Florida, United States, 33176
        • Visionary Investigators Network - South Miami
      • Orlando, Florida, United States, 32751
        • K2
      • Pembroke Pines, Florida, United States, 33026
        • Visionary Investigators Network - Pembroke Pines
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research of Florida
      • Winter Park, Florida, United States, 32792
        • Charter Research - Winter Park
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
    • Kansas
      • Fairway, Kansas, United States, 66160
        • Kansas University Alzheimer's Disease Center (KUADC)
    • New York
      • Syracuse, New York, United States, 13057
        • Velocity Clinical Research - Syracuse
    • Texas
      • Dallas, Texas, United States, 75231
        • Kerwin Research Center
      • Rio Grande City, Texas, United States, 78582
        • El Faro Health and Therapeutics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 1,000 participants

Description

Inclusion Criteria:

Participants must meet all the following criteria for entry into the study:

  1. Participants must provide written consent in the IRB-approved informed consent form or have a Legally Authorized Representative (LAR) provide written consent in the IRB-approved consent form on the participant's behalf;
  2. Male or female 60 to 85 years of age (inclusive) at the time of consent;
  3. Participants must be willing to undergo an amyloid PET scan within 60 days of signing informed consent; or for sites that do not have access to PET imaging, the participant must be willing to undergo a lumbar puncture for cerebrospinal fluid (CSF) collection within 30 days of the coagulation panel;
  4. Participants must have a study partner who, in the investigator's judgement, has sufficient and frequent contact (defined as at least 8 hours of contact a week) with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities;
  5. Participants must be willing to comply with all study procedures as outlined in the informed consent, including blood sampling;
  6. Fluency in the language of the tests used at the study site;
  7. Participants must be willing to be contacted for possible participation in clinical research trials once their participation in this study ends; and
  8. Participants must have a Mini-Mental State Exam (MMSE) score of 17 to 30 inclusive at screening; those with a score of 17-19 must have a diagnosis of Probable AD.

Exclusion Criteria

Participants who meet any of the following criteria will not be eligible for entry into the study:

  1. Participants who, in the opinion of the Site Principal Investigator, have serious or unstable medical conditions that would prohibit their completion of all study procedures and data collection;
  2. Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial;
  3. Participants who are unable to undergo amyloid PET due to self-reported pregnancy, sensitivity of ligands being used, poor venous access, contraindication to PET, or planned or recent exposure to ionizing radiation that in combination with the planned administration of amyloid radioligand would result in a cumulative exposure that exceeds recommended local guidelines;
  4. Participants who have reported or have a known negative amyloid PET scan in past 12 months;
  5. Participants with self-reported, untreated conditions such as vitamin B12 or folate deficiency or bladder infections that in the opinion of the Site Principal Investigator could contribute to cognitive impairment;
  6. Participants with history of stroke or seizures within 1 year of the Visit 1 (Screening);
  7. Participants with history of cancer within the past 5 years with the exception of non-melanoma skin cancer or prostate cancer in situ;
  8. Participants with known or suspected alcohol or drug abuse or dependence within 1 year of the Visit 1 (Screening);
  9. Participants who report any current unstable psychiatric symptoms that could interfere with study procedures or impact study data (e.g., uncontrolled depression);
  10. Participants who have participated in a clinical trial of any potential disease modifying AD treatment and received active drug within 6 months prior to Visit 1 (Screening);
  11. Participants who have completed clinical or observational study procedures (e.g., imaging, cognitive testing) within 3 months of Visit 1 (Screening);
  12. Participants who have any neurological disorder affecting the central nervous system, other than AD, that may be contributing to cognitive impairment (e.g., Parkinson's disease, other dementias, multiple concussions or seizures) as deemed significant by the Site Principal Investigator;
  13. Participants with a Geriatric Depression Scale (GDS) score greater than or equal to 8 at Visit 1 (Screening);
  14. Participants with a RAVLT-Delayed Recall Score of 1.5 standard deviation above the age-adjusted mean;
  15. Participants with known history or self-report to be Human Immunodeficiency Virus (HIV) Positive;
  16. Participants weighing less than 110 pounds;
  17. Participants that have previously been consented to this study unless prior approval was granted by the Sponsor on a case-by-case basis;
  18. Participants who are direct employees or family members of direct employees of the participating investigators' sites;
  19. Participants who are direct employees of the Sponsor;
  20. Participants who, in the opinion of the investigator, are unable to complete cognitive testing due to inadequate visual or auditory acuity;
  21. For participants of the RetiSpec retinal substudy only: Those with a known history of ocular diseases (such as retinopathy, age-related macular degeneration, and glaucoma), with the exception of mild to moderate cataracts, and/or vision correction with glasses/contact lenses;
  22. For participants undergoing LP: contraindication to lumbar puncture, including coagulopathy, concomitant anticoagulation (except for a platelet inhibitor such as aspirin or clopidogrel), thrombocytopenia, prior lumbar spinal surgery, significant deformity of the lumbosacral region, INR results > 1.3, or other factor that precludes safe LP in the opinion of the Site Principal Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of each participant's blood-based biomarker (Beta-Amyloid, Phospho-Tau, Neurofilament Light Chain) levels will be collected through blood sampling.
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Measurement of each participant's amyloid levels in the brain will be collected through amyloid PET brain scan imaging.
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GAP Innovations, PBC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 21, 2021

Primary Completion (ACTUAL)

November 11, 2022

Study Completion (ACTUAL)

November 11, 2022

Study Registration Dates

First Submitted

December 28, 2020

First Submitted That Met QC Criteria

January 27, 2021

First Posted (ACTUAL)

February 2, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-HERMES-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Biomarker Data Collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe