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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

ConditionsMild Cognitive ImpairmentAlzheimer's DiseaseAlzheimer's Disease, Early OnsetMemory LossMemory DisordersMemory Impairment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-90
SponsorGAP Innovations, PBC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Biomarker Data Collection

    Other intervention

    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

    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.

Treatment groups

1,200 Participants
are divided into 3 treatment groups
Group A: Cognitively Normal2 interventions
Group B: Mild Cognitive Impairment2 interventions
Group C: Mild-to-Moderate AD Dementia2 interventions

Trial outcomes

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.

Time frame
Through study completion, an average of 3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GAP Innovations, PBC

Lead sponsor

Source ClinicalTrials.gov
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