Purpose

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

Eligibility

Eligible Ages
Between 60 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

Pre-screening Inclusion Criteria Participants must meet ALL of the following criteria to progress to Visit 1 (Screening): 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. Core Study Inclusion Criteria Participants must meet ALL of the following criteria, in addition to the Pre-screening Inclusion Criteria, for entry into the study: 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.

Exclusion Criteria

Pre-screening Exclusion Criteria Participants who meet ANY of the following criteria will not be eligible to progress to Visit 1 (Screening): 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. Core Study Exclusion Criteria Participants who meet ANY of the following criteria, in addition to the Pre-screening Exclusion Criteria, will not be eligible to enroll 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 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 Inclusion Criteria: 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: 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.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
Cognitively Normal No reported memory loss or concerns as reported by participant and study partner.
  • 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 AD. Some of the samples will be stored for future analysis.
  • Radiation: 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.
  • 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 AD. Some of the samples will be stored for future analysis.
  • Radiation: 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.
  • 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 AD. Some of the samples will be stored for future analysis.
  • Radiation: 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.

Recruiting Locations

JEM Research Institute
Atlantis 4146372, Florida 4155751 33462
Contact:
Erin McBride
561-968-2933
emcbride@jemri.net

Visionary Investigators Network
Aventura 4146429, Florida 4155751 33180
Contact:
Nicole Rios
954-250-2379
nrios@vintrials.com

K2 - Winter Garden
Clermont 4151352, Florida 4155751 34711
Contact:
Anjali Mahavir
321-340-4786
anjali.mahavir@k2med.com

Brain Matters Research
Delray Beach 4153132, Florida 4155751 33445
Contact:
Laura Ystha Alonso
561-374-8461 EXT 1002
RecruitmentBMR@ergclinical.com

Neuropsychiatric Research Center of SW Florida
Fort Myers 4155995, Florida 4155751 33912
Contact:
Stephanie Gillis
239-939-7777
sgillis@ergclinical.com

K2 Medical Research
Maitland 4163220, Florida 4155751 32751
Contact:
Tiffany Kiako
407-447-4342
Tiffany.Kiako@k2med.com

Clincloud
Melbourne 4163971, Florida 4155751 32940
Contact:
Erin Frank
407-680-0534
efrank@myclincloud.com

Visionary Investigators Network
Miami 4164138, Florida 4155751 33133
Contact:
Dayana Torres
786-655-8010
dtorres@vintrials.com

Charter Research
Orlando 4167147, Florida 4155751 32803
Contact:
Celynez Gomez
407-337-1000
celynez.gomez@charterresearch.com

Progressive Medical Research
Port Orange 4169156, Florida 4155751 32127
Contact:
Kyrie Allen
386-304-7070
kryiem@progressivemedicalresearch.com

Intercoastal Medical Group, Inc.
Sarasota 4172131, Florida 4155751 34239
Contact:
Jeanette Wilson
941-203-3750
jewilson@intercoastalmedical.com

Axiom Brain Health
Tampa 4174757, Florida 4155751 33609
Contact:
Johannes Dessoy
813-353-9613
jdessoy@axiombrainhealth.com

Conquest Research
Winter Park 4178560, Florida 4155751 32789
Contact:
Jairo Argueta
407-916-0060
Jairo.Argueta@conquestresearch.com

Flourish Research - Chicago
Chicago 4887398, Illinois 4896861 60640
Contact:
areeves@flourishresearch.com
773-275-3500
areeves@flourishresearch.com

Quest Research Institute
Farmington Hills 4992523, Michigan 5001836 48334
Contact:
Jorge Isunza
248-957-8940
jorge.isunza@questri.com

Clinical Neurology Specialists
Las Vegas 5506956, Nevada 5509151 89147
Contact:
Sarah Freeland
702-381-2882
LasVegasResearch@GlobalAlzPlatform.org

K2 Medical Research
East Providence 5221931, Rhode Island 5224323 02914
Contact:
Sam Slezak
401-209-1079
sam.slezak@k2med.com

Gadolin Research LLC
Beaumont 4672989, Texas 4736286 77702
Contact:
Alexia Tran
(409) 331-6040
atran@gadolin.com

Re:Cognition Health
Houston 4699066, Texas 4736286 77030
Contact:
Laura Vaquerano
(346)568-0809
lvaquerano@re-cognitionhealth.com

More Details

Status
Recruiting
Sponsor
GAP Innovations, PBC

Study Contact

Amanda Ng, MA
biohermes-002@globalalzplatfor
biohermes-002@globalalzplatform.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.