Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia
NCT ID: NCT06584357
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1200 participants
OBSERVATIONAL
2024-09-26
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Cognitively Normal
No reported memory loss or concerns as reported by participant and study partner.
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 AD. Some of the samples will be stored for future analysis.
MK6240
Each participant will be assessed using either one of two radioactive tau PET tracers: Flortaucipir or MK6240. Flortaucipir is FDA approved while MK6240 is not and is being used in this study as an investigational radioactive drug.
Mild Cognitive Impairment
A diagnosis of Mild Cognitive Impairment (MCI) based on the National Institute of Aging (NIA) criteria and verified through medical records.
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 AD. Some of the samples will be stored for future analysis.
MK6240
Each participant will be assessed using either one of two radioactive tau PET tracers: Flortaucipir or MK6240. Flortaucipir is FDA approved while MK6240 is not and is being used in this study as an investigational radioactive drug.
Mild-to-Moderate AD Dementia
A diagnosis of Mild-to-Moderate AD Dementia based on the National Institute of Aging (NIA) criteria and verified through medical records.
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 AD. Some of the samples will be stored for future analysis.
MK6240
Each participant will be assessed using either one of two radioactive tau PET tracers: Flortaucipir or MK6240. Flortaucipir is FDA approved while MK6240 is not and is being used in this study as an investigational radioactive drug.
Interventions
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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 AD. Some of the samples will be stored for future analysis.
MK6240
Each participant will be assessed using either one of two radioactive tau PET tracers: Flortaucipir or MK6240. Flortaucipir is FDA approved while MK6240 is not and is being used in this study as an investigational radioactive drug.
Eligibility Criteria
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Inclusion Criteria
1. Participant is between 60 to 90 years of age (inclusive) at the time of consent; and
2. Participant has a study partner who has sufficient and frequent contact with the participant (defined as at least 8 hours of contact a week) and is able to provide accurate information regarding the participant's cognitive and functional abilities.
1. Participants must provide written consent in the IRB-approved or Ethics Committee (EC) approved informed consent form or have a legally authorized representative (LAR) provide written consent on the participant's behalf in accordance with local and national guidance and regulation;
2. Participants must be willing to undergo an MRI brain scan within 90 days and an amyloid and tau PET scan within 120 days of signing informed consent;
3. Participants must be willing to comply with all study procedures as outlined in the informed consent, including blood sampling, genetic testing, and storage of biospecimens for future research;
4. Fluency in the language of the tests used at the study site;
5. Participants must be willing to be contacted for possible participation in clinical research trials once their participation in this study ends; and
6. Participants must have a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusive at screening.
Participants must meet ALL of the following criteria for entry into the sub-study:
1. Participants who completed the Bio-Hermes-002 Core Study;
2. Are willing to complete phone call visits with site staff every three months and return to the clinic for an annual evaluation; and
3. Are willing to complete annual PET scans for both amyloid and tau scans.
Exclusion Criteria
1. Participant is unable to undergo amyloid and tau PET scans due to self-reported pregnancy, sensitivity to 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;
2. Participants who have reported or have a known negative amyloid PET scan in the past 6 months;
3. Participants with any known contraindication to brain MRI scan;
4. Participants with history of stroke or seizures within 1 year of the Pre-Screening Visit;
5. Participants with history of cancer within the past 5 years with the exception of non-melanoma skin cancer or prostate cancer in situ;
6. Participants with known or suspected alcohol or drug abuse or dependence within 1 year of the Pre- Screening Visit;
7. Participants who report any current unstable psychiatric symptoms that could interfere with study procedures or impact study data (e.g., uncontrolled depression);
8. Participants who have received any potential disease modifying AD treatment within 6 months prior to the Pre-screening Visit; and
9. Participants with known history or self-report to be Human Immunodeficiency Virus (HIV) Positive unless controlled by antiviral medication.
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 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;
4. Participants who have completed cognitive testing within 1 month of Visit 1 (Screening) where the Site Principal Investigator believes the participant's exposure may cause practice effect;
5. 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;
6. Participants with a Geriatric Depression Scale (GDS) score greater than or equal to 8 at Visit 1 (Screening) and is deemed to be clinically significantly depressed by the Site Principal Investigator;
7. Participants with a Rey Auditory Verbal Learning Test (RAVLT) t-score of ≥ 1.2 standard deviation above the mean. For non-African Americans, calculate age-sex-education adjusted t-scores. For African American participants, use the MOANS to calculate the age-education adjusted t-scores;
8. Participants weighing less than 110 pounds;
9. Participants who are direct employees or family members of direct employees of the participating investigators' sites;
10. Participants who are direct employees of the Sponsor;
11. Participants who, in the opinion of the investigator, are unable to complete cognitive testing due to inadequate visual or auditory acuity; and
12. For participants completing the RetiSpec retinal scan: Those with a known history of contraindication or allergy to Tropicamide 1% (pupil dilation drop).
Longitudinal Sub-Study Eligibility
Participants who meet ANY of the following criteria will not be eligible for entry into the sub-study:
1. Those who are enrolled or intend to enroll into a clinical trial for Alzheimer's disease with a potential disease-modifying intervention;
2. Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial;
3. Those who intend to use medications outside clinical research studies approved by regulatory authorities to modify Alzheimer's disease pathology.
60 Years
90 Years
ALL
Yes
Sponsors
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GAP Innovations, PBC
INDUSTRY
Responsible Party
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Locations
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JEM Research Institute
Atlantis, Florida, United States
Visionary Investigators Network
Aventura, Florida, United States
K2 - Winter Garden
Clermont, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of SW Florida
Fort Myers, Florida, United States
K2 Medical Research
Maitland, Florida, United States
Clincloud
Melbourne, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
Charter Research
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Intercoastal Medical Group, Inc.
Sarasota, Florida, United States
Axiom Brain Health
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
Flourish Research - Chicago
Chicago, Illinois, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Clinical Neurology Specialists
Las Vegas, Nevada, United States
ADRC of Albany
Albany, New York, United States
Neuro-Behavioral Clinical Research Inc.
North Canton, Ohio, United States
Flourish Research - Philadelphia
Philadelphia, Pennsylvania, United States
K2 Medical Research
East Providence, Rhode Island, United States
Gadolin Research LLC
Beaumont, Texas, United States
Re:Cognition Health
Houston, Texas, United States
Toronto Memory Program
Toronto, Ontario, Canada
NeuroClin Glasgow
Motherwell, North Lanarkshire, United Kingdom
Re:Cognition Health
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Erin McBride
Role: primary
Nicole Rios
Role: primary
Anjali Mahavir
Role: primary
Laura Marquez
Role: primary
Stephanie Gillis
Role: primary
Tiffany Kiako
Role: primary
Erin Frank
Role: primary
Dayana Torres
Role: primary
Celynez Gomez
Role: primary
Edgardo Rivera, MD
Role: backup
Kyrie Allen
Role: primary
Jeanette Wilson
Role: primary
Johannes Dessoy
Role: primary
Jairo Argueta
Role: primary
[email protected]
Role: primary
Jorge Isunza
Role: primary
Sarah Freeland
Role: primary
Aparna Pabbisetty
Role: primary
Jim Weir
Role: primary
Sam Slezak
Role: primary
Alexia Tran
Role: primary
Laura Vaquerano
Role: primary
Barathy Tharmalingam
Role: primary
Erin McCrone
Role: primary
Amelia Buttifant
Role: primary
Other Identifiers
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Bio-Hermes-002
Identifier Type: -
Identifier Source: org_study_id