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

NCT06584357 | Recruiting FDA Drug

• 1 other identifier: Bio-Hermes-002
• Study Type: observational
• Target: 1,200
• Locations: 3 countries
• Sites: 26

Brief Summary

Bio-Hermes-002 is a 120-day cross-sectional study that will result in a blood, CSF, retinal, digital, MRI, and PET brain imaging biomarker database that can be used to determine the primary objective. Digital biomarkers and blood-based biomarkers will be tested to determine whether a meaningful relationship exists between biomarkers alone or in combination with tau or amyloid brain pathology identified through PET images.

Conditions

Mild Cognitive Impairment; Memory Loss; Alzheimer's Disease; Alzheimer's Disease, Early Onset; Memory Disorders; Memory Impairment

Keywords

Alzheimer's Disease; Alzheimer's Disease, Early Onset; Mild Cognitive Impairment; Older Volunteers; Healthy Volunteers; Memory Loss; Memory Disorders; Memory Impairment

Outcome Measures

Primary Outcomes (1)

• Biomarkers and PET

  Measure blood biomarkers (Aβ 42/40, p-tau 181, p-tau 217, p-tau 231, total tau, and NFL) to see if it will predict the extent of tau and amyloid brain pathology as measured by PET brain imaging in participants shown to be cognitively normal (CN), have mild cognitive impairment (MCI), or have mild-to-moderate AD dementia.

  Through study completion, an average of 3 years

Study Arms (3)

Cognitively Normal

No reported memory loss or concerns as reported by participant and study partner.

Other: Biomarker Data Collection; Radiation: MK6240

Mild Cognitive Impairment

A diagnosis of Mild Cognitive Impairment (MCI) based on the National Institute of Aging (NIA) criteria and verified through medical records.

Other: Biomarker Data Collection; Radiation: MK6240

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.

Other: Biomarker Data Collection; Radiation: MK6240

Interventions

Biomarker Data Collection OTHER

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.

Cognitively Normal; Mild Cognitive Impairment; Mild-to-Moderate AD Dementia

MK6240 RADIATION

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.

Cognitively Normal; Mild Cognitive Impairment; Mild-to-Moderate AD Dementia

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to 1,200 participants will complete all the activities of the protocol over an 18-month competitive enrollment period. Each site will be expected to enroll approximately 40 participants. Approximately 25% of the total participants enrolled will be from underrepresented populations. Enrolled participants will be characterized as fitting into one of three cohorts with approximately 1/3 enrollment in each cohort. While we have outlined cohort criteria below, ultimately it is up to the site principal investigator to determine cohort placement. Cohort status will not be shared with participants.

You may qualify if:

• Participants must meet ALL of the following criteria to progress to Visit 1 (Screening):
• Participant is between 60 to 90 years of age (inclusive) at the time of consent; and
• 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.
• 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;
• 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;
• 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;
• Fluency in the language of the tests used at the study site;
• Participants must be willing to be contacted for possible participation in clinical research trials once their participation in this study ends; and
• Participants must have a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusive at screening.

You may not qualify if:

• Participants who meet ANY of the following criteria will not be eligible to progress to Visit 1 (Screening):
• 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;
• Participants who have reported or have a known negative amyloid PET scan in the past 6 months;
• Participants with any known contraindication to brain MRI scan;
• Participants with history of stroke or seizures within 1 year of the Pre-Screening Visit;
• Participants with history of cancer within the past 5 years with the exception of non-melanoma skin cancer or prostate cancer in situ;
• Participants with known or suspected alcohol or drug abuse or dependence within 1 year of the Pre- Screening Visit;
• Participants who report any current unstable psychiatric symptoms that could interfere with study procedures or impact study data (e.g., uncontrolled depression);
• Participants who have received any potential disease modifying AD treatment within 6 months prior to the Pre-screening Visit; and
• Participants with known history or self-report to be Human Immunodeficiency Virus (HIV) Positive unless controlled by antiviral medication.
• 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;
• Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial;
• 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;
• 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;
• 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;

Sponsors & Collaborators

• GAP Innovations, PBC: lead

Study Sites (26)

JEM Research Institute

Atlantis, Florida, 33462, United States

RECRUITING

Visionary Investigators Network

Aventura, Florida, 33180, United States

RECRUITING

K2 - Winter Garden

Clermont, Florida, 34711, United States

RECRUITING

Brain Matters Research

Delray Beach, Florida, 33445, United States

RECRUITING

Neuropsychiatric Research Center of SW Florida

Fort Myers, Florida, 33912, United States

RECRUITING

K2 Medical Research

Maitland, Florida, 32751, United States

RECRUITING

Clincloud

Melbourne, Florida, 32940, United States

RECRUITING

Visionary Investigators Network

Miami, Florida, 33133, United States

RECRUITING

Charter Research

Orlando, Florida, 32803, United States

RECRUITING

Progressive Medical Research

Port Orange, Florida, 32127, United States

RECRUITING

Intercoastal Medical Group, Inc.

Sarasota, Florida, 34239, United States

RECRUITING

Axiom Brain Health

Tampa, Florida, 33609, United States

RECRUITING

Conquest Research

Winter Park, Florida, 32789, United States

RECRUITING

Flourish Research - Chicago

Chicago, Illinois, 60640, United States

RECRUITING

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

Clinical Neurology Specialists

Las Vegas, Nevada, 89147, United States

RECRUITING

ADRC of Albany

Albany, New York, 12208, United States

COMPLETED

Neuro-Behavioral Clinical Research Inc.

North Canton, Ohio, 44720, United States

COMPLETED

Flourish Research - Philadelphia

Philadelphia, Pennsylvania, 19462, United States

ACTIVE NOT RECRUITING

K2 Medical Research

East Providence, Rhode Island, 02914, United States

RECRUITING

Gadolin Research LLC

Beaumont, Texas, 77702, United States

RECRUITING

Re:Cognition Health

Houston, Texas, 77030, United States

RECRUITING

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

RECRUITING

NeuroClin Glasgow

Motherwell, North Lanarkshire, ML1 4UF, United Kingdom

RECRUITING

Re:Cognition Health

London, W1G 8TA, United Kingdom

RECRUITING

Dementia Research Centre, UCLH

London, WC1N 3BG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* LucentAD * APOE * Aβ 42/40 * p-tau 181/217/231 * Total tau * NfL * Genome sequencing * Proteomics * Photonics * Other measures of neuroinflammation: GFAP, YKL-40, MCP-1, Factor B, Factor H, sCRI, Eotaxin, TNFα, CD8+T effector memory cells, DNases and RNases

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Memory Disorders

Interventions

MK-6240

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amanda Ng, MA

CONTACT

biohermes-002@globalalzplatfor; biohermes-002@globalalzplatform.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 4, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

GB (3); US (22); CA (1)