Mild Cognitive ImpairmentBio-Hermes-002NCT06584357
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
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by GAP Innovations, PBC at 26 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease, Alzheimer's Disease, Early Onset
- What is being tested?
- Biomarker Data Collection and MK6240
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 26 sitesin 3 countries
- Study dates
- 26 Sep 2024to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Pre-screening Inclusion Criteria
- 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.
- 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:
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- 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.
- Participants must meet ALL of the following criteria for entry into the sub-study:
- Participants who completed the Bio-Hermes-002 Core Study;
- Are willing to complete phone call visits with site staff every three months and return to the clinic for an annual evaluation; and
- Are willing to complete annual PET scans for both amyloid and tau scans.
Who cannot join
- Pre-screening Exclusion Criteria
- 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;
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- 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.
- 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:
- 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;
- 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;
- 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;
- Participants weighing less than 110 pounds;
- Participants who are direct employees or family members of direct employees of the participating investigators' sites;
- Participants who are direct employees of the Sponsor;
- Participants who, in the opinion of the investigator, are unable to complete cognitive testing due to inadequate visual or auditory acuity; and
- 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:
- Those who are enrolled or intend to enroll into a clinical trial for Alzheimer's disease with a potential disease-modifying intervention;
- Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial;
- Those who intend to use medications outside clinical research studies approved by regulatory authorities to modify Alzheimer's disease pathology.
Trial locations and contacts
26 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 3 countries
United States22 sites, 19 recruiting
- Completed
ADRC of Albany
Albany, New York, 12208
- Recruiting
JEM Research Institute
Atlantis, Florida, 33462
Erin McBride, 561-968-2933, emcbride@jemri.net
Linda Pao, MD
- Recruiting
Visionary Investigators Network
Aventura, Florida, 33180
Nicole Rios, 954-250-2379, nrios@vintrials.com
Julie Schwartzbard, MD
- Recruiting
Gadolin Research LLC
Beaumont, Texas, 77702
Alexia Tran, (409) 331-6040, atran@gadolin.com
Kandasami Senthilkumar, MD
- Recruiting
Flourish Research - Chicago
Chicago, Illinois, 60640
areeves@flourishresearch.com, 773-275-3500, areeves@flourishresearch.com
Jeffrey Ross, MD
- Recruiting
K2 - Winter Garden
Clermont, Florida, 34711
Anjali Mahavir, 321-340-4786, anjali.mahavir@k2med.com
Nicholas Weber, DO
- Recruiting
Brain Matters Research
Delray Beach, Florida, 33445
Laura Ystha Alonso, 561-374-8461 EXT 1002, RecruitmentBMR@ergclinical.com
Paayal Patel, MD
- Recruiting
K2 Medical Research
East Providence, Rhode Island, 02914
Sam Slezak, 401-209-1079, sam.slezak@k2med.com
Daniel Sacchetti, MD
- Recruiting
Quest Research Institute
Farmington Hills, Michigan, 48334
Jorge Isunza, 248-957-8940, jorge.isunza@questri.com
Aaron Ellenbogen, MD
- Recruiting
Neuropsychiatric Research Center of SW Florida
Fort Myers, Florida, 33912
Stephanie Gillis, 239-939-7777, sgillis@ergclinical.com
John Huffaker, DNP, FNP-C
- Recruiting
Re:Cognition Health
Houston, Texas, 77030
Laura Vaquerano, (346)568-0809, lvaquerano@re-cognitionhealth.com
Avni Kapadia, MD
- Recruiting
Clinical Neurology Specialists
Las Vegas, Nevada, 89147
Sarah Freeland, 702-381-2882, LasVegasResearch@GlobalAlzPlatform.org
Leo Germin, MD
- Recruiting
K2 Medical Research
Maitland, Florida, 32751
Tiffany Kiako, 407-447-4342, Tiffany.Kiako@k2med.com
Sheila Baez-Torres
- Recruiting
Clincloud
Melbourne, Florida, 32940
Erin Frank, 407-680-0534, efrank@myclincloud.com
Rosemary Laird, MD
- Recruiting
Visionary Investigators Network
Miami, Florida, 33133
Dayana Torres, 786-655-8010, dtorres@vintrials.com
Andrew Lerman
- Completed
Neuro-Behavioral Clinical Research Inc.
North Canton, Ohio, 44720
- Recruiting
Charter Research
Orlando, Florida, 32803
Celynez Gomez, 407-337-1000, celynez.gomez@charterresearch.com
Edgardo Rivera, MD
- Active, not recruiting
Flourish Research - Philadelphia
Philadelphia, Pennsylvania, 19462
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
Kyrie Allen, 386-304-7070, kryiem@progressivemedicalresearch.com
Alexander White, MD
- Recruiting
Intercoastal Medical Group, Inc.
Sarasota, Florida, 34239
Jeanette Wilson, 941-203-3750, jewilson@intercoastalmedical.com
Maurico Concha, MD
- Recruiting
Axiom Brain Health
Tampa, Florida, 33609
Johannes Dessoy, 813-353-9613, jdessoy@axiombrainhealth.com
Susan Steen, MD
- Recruiting
Conquest Research
Winter Park, Florida, 32789
Jairo Argueta, 407-916-0060, Jairo.Argueta@conquestresearch.com
Malisa Agard
United Kingdom3 sites, 3 recruiting
- Recruiting
Re:Cognition Health
London, W1G 8TA
Amelia Buttifant, (0)20 3355 3536, abuttifant@re-cognitionhealth.com
Emer Macsweeney, MD
- Recruiting
Dementia Research Centre, UCLH
London, WC1N 3BG
Mobeen Fazal, 0203 448 3054, mobeen.fazal1@nhs.net
Catherine Mummery, MD
- Recruiting
NeuroClin Glasgow
Motherwell, North Lanarkshire, ML1 4UF
Erin McCrone, 0141 948 0206, erin.mccrone@neuroclin.co.uk
Jennifer Lynch, MD
Canada1 site, 1 recruiting
- Recruiting
Toronto Memory Program
Toronto, Ontario, M3B 2S7
Barathy Tharmalingam, 416-386-9761 ext. ext. 310, barathy.tharmalingam@memorydisorders.ca
Sharon Cohen, MD
About this study
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, Alzheimer's Disease, Alzheimer's Disease, Early Onset, Memory Loss, Memory Disorders, Memory Impairment
- Being tested
- Biomarker Data Collection, MK6240
- Keywords
- Alzheimer's Disease, Alzheimer's Disease, Early Onset, Mild Cognitive Impairment, Older Volunteers, Healthy Volunteers, Memory Loss, Memory Disorders, Memory Impairment
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker Data CollectionOther
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.
MK6240Radiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively Normal | No reported memory loss or concerns as reported by participant and study partner. Receives: 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. Receives: 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. Receives: Other: Biomarker Data Collection; Radiation: MK6240 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start26 Sep 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GAP Innovations, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584357
- Sponsor's protocol ID
- Bio-Hermes-002
- Acronym
- Bio-Hermes-002
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared but the plan has not been finalized.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06584357
- Acronym / sponsor ID
- Bio-Hermes-002 / Bio-Hermes-002
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease, Alzheimer's Disease, Early Onset, Memory Loss, 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- GAP Innovations, PBCIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitively Normal | – | Other: Biomarker Data Collection, Radiation: MK6240No reported memory loss or concerns as reported by participant and study partner. |
| Mild Cognitive Impairment | – | Other: Biomarker Data Collection, Radiation: MK6240A diagnosis of Mild Cognitive Impairment (MCI) based on the National Institute of Aging (NIA) criteria and verified through medical records. |
| Mild-to-Moderate AD Dementia | – | Other: Biomarker Data Collection, Radiation: MK6240A diagnosis of Mild-to-Moderate AD Dementia based on the National Institute of Aging (NIA) criteria and verified through medical records. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- Pre-screening Inclusion Criteria
- 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.
- 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:
Key exclusion criteria (30 listed)
- Pre-screening Exclusion Criteria
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker Data CollectionDuring 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. | Other | Cognitively Normal, Mild Cognitive Impairment, Mild-to-Moderate AD Dementia |
| MK6240Each 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. | Radiation | Cognitively Normal, Mild Cognitive Impairment, Mild-to-Moderate AD Dementia |
Primary outcome
Biomarkers and PET
Time frame: Through study completion, an average of 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. IPD may be shared but the plan has not been finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer's Disease, run by GAP Innovations, PBC at 26 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Ng, MA (biohermes-002@globalalzplatfor, biohermes-002@globalalzplatform.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers and PET (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.