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

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ClinicalTrials.gov Identifier: NCT04733989
Recruitment Status : Completed
First Posted : February 2, 2021
Last Update Posted : February 9, 2023
Sponsor:
Information provided by (Responsible Party):
GAP Innovations, PBC

Study Description
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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

Study Design
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Study Type : Observational
Actual Enrollment : 1002 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
Actual Primary Completion Date : November 11, 2022
Actual Study Completion Date : November 11, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.

Outcome Measures
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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

Eligibility Criteria
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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:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 1,000 participants
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04733989


Locations
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United States, Florida
Visionary Investigators Network - Aventura
Aventura, Florida, United States, 33180
Visionary Investigators Network - Coral Gables
Coral Gables, Florida, United States, 33133
Charter Research - Lady Lake
Lady Lake, Florida, United States, 32159
JEM
Lake Worth, Florida, United States, 33462
ClinCloud
Maitland, Florida, United States, 32751
Visionary Investigators Network - South Miami
Miami, Florida, United States, 33176
K2
Orlando, Florida, United States, 32751
Visionary Investigators Network - Pembroke Pines
Pembroke Pines, Florida, United States, 33026
Progressive Medical Research
Port Orange, Florida, United States, 32127
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
Charter Research - Winter Park
Winter Park, Florida, United States, 32792
United States, Illinois
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
United States, Kansas
Kansas University Alzheimer's Disease Center (KUADC)
Fairway, Kansas, United States, 66160
United States, New York
Velocity Clinical Research - Syracuse
Syracuse, New York, United States, 13057
United States, Texas
Kerwin Research Center
Dallas, Texas, United States, 75231
El Faro Health and Therapeutics
Rio Grande City, Texas, United States, 78582
Sponsors and Collaborators
GAP Innovations, PBC
More Information
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Publications:
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. https://healthpolicy.usc.edu/wp-content/uploads/2020/08/Key-Barriers-to-Clinical-Trials-for-Alzheimer%E2%80%99s-Disease_FINAL.pdf. Accessed December 01, 2020.
US Food and Drug Administration. De Novo Classification Request For Cognivue. De Novo Summary (DEN130033). www.accessdata.fda.gov/cdrh_docs/reviews/DEN130033.pdf. Accessed December 7, 2020.

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Responsible Party: GAP Innovations, PBC
ClinicalTrials.gov Identifier: NCT04733989    
Other Study ID Numbers: BIO-HERMES-001
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 9, 2023
Last Verified: February 2023
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
Amnesia
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations