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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04733989
Recruitment Status : Recruiting
First Posted : February 2, 2021
Last Update Posted : June 14, 2021
Information provided by (Responsible Party):
GAP Innovations, PBC

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 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.

Condition or disease Intervention/treatment
Alzheimer Disease Alzheimer Disease, Early Onset Mild Cognitive Impairment Memory Loss Memory Disorders Memory Impairment Other: Biomarker Data Collection

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Alzheimer's Disease (AD), Prodromal AD, or Mild AD
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Biospecimen Retention:   Samples With DNA
Beta-Amyloid, Phospho-Tau, Neurofilament Light Chain, DNA, RNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 1,000 participants

Inclusion Criteria:

  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;
  4. Participants must have a study partner who, in the investigator's judgement, has sufficient and frequent contact 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 an MMSE score of 20 to 30 inclusive at screening.

Exclusion Criteria:

  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 (eg, 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 (eg, 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 (eg, 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;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04733989

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Contact: Sarah Hollingshead 352-247-1982
Contact: Jennifer Gaudioso

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United States, Florida
Visionary Investigators Recruiting
Aventura, Florida, United States, 33180
Contact: Jose Macias    954-243-5559   
Principal Investigator: Julie Schwartzbard, MD         
Charter Research Recruiting
Lady Lake, Florida, United States, 32159
Contact: Tina Blair    352-775-1000   
Contact: Jessica Sletten    352-775-1000   
Principal Investigator: Jeffrey Norton, MD         
JEM Recruiting
Lake Worth, Florida, United States, 33462
Contact: Janette Bossaers    561-968-2933   
Principal Investigator: Mark Goldstein, MD         
ClinCloud Recruiting
Maitland, Florida, United States, 32751
Contact: Mike Martinez    407-636-4031   
Contact: Jessica Branning    407-636-4031   
Principal Investigator: Esteban Olivera, MD         
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
Contact: Basil White    386-304-7070   
Principal Investigator: Alexander White, MD         
Axiom Clinical Research of Florida Not yet recruiting
Tampa, Florida, United States, 33609
Contact: Haitham Abulaban    813-353-9613   
Principal Investigator: Susan Steen, MD         
United States, Illinois
Great Lakes Clinical Trials Recruiting
Chicago, Illinois, United States, 60640
Contact: Steve Satek    773-275-3500   
Principal Investigator: Jeffrey Ross, MD         
United States, Kansas
Kansas University Alzheimer's Disease Center (KUADC) Not yet recruiting
Fairway, Kansas, United States, 66160
Contact: Rebecca Bothwell    913-588-0555   
Contact: Eric Vidoni, PhD    913-588-0555   
Principal Investigator: Samantha Fikru, MSN, FNP-C         
United States, New York
Clarity Clinical Research Recruiting
Syracuse, New York, United States, 13057
Contact: Lisa Sonneborn    315-760-5905   
Principal Investigator: Karl Hafner, MD         
United States, Texas
Kerwin Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Micah Eimerbrink, PhD    972-433-9100   
Principal Investigator: Diana Kerwin, MD         
Sponsors and Collaborators
GAP Innovations, PBC
Ingelfinger, JA, Mosteller, R, Thibodeau, LA, Ware, JA. Biostatistics in Clinical Medicine. 3rd ed. New York, N.Y.: McGraw-Hill, New York; 1994.
Malzbender K, Lavin-Mena L, Hughes L, Bose N, Goldman D, Patel D. White Paper on Key Barriers to Clinical Trials for Alzheimer's Disease. USC Schaeffer Center for Health Policy & Economics and Gates Ventures. August 2020. Accessed December 01, 2020.
US Food and Drug Administration. De Novo Classification Request For Cognivue. De Novo Summary (DEN130033). Accessed December 7, 2020.

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Responsible Party: GAP Innovations, PBC Identifier: NCT04733989    
Other Study ID Numbers: BIO-HERMES-001
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GAP Innovations, PBC:
Alzheimer's disease
Alzheimer Disease, Early Onset
Mild Cognitive Impairment
Memory Loss
Memory Disorders
Memory Impairment
Older Volunteers
Healthy Volunteers
Additional relevant MeSH terms:
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Alzheimer Disease
Memory Disorders
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations