RecruitingPhase not listed

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 90 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 120-day study looks at whether blood tests and digital tests are linked to amyloid and tau, proteins seen on PET brain scans. It is for adults ages 60 to 90 with normal memory and thinking, mild thinking problems, or mild-to-moderate Alzheimer's dementia. The study will build a database for research.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 60 to 90 years old.
  • Have a study partner who spends at least 8 hours a week with you and can report on your thinking and daily skills.
  • Give written consent, or have a legally authorized person give consent for you.
  • Agree to an MRI brain scan within 90 days and amyloid and tau PET brain scans within 120 days after consent.
  • Agree to all study steps, including blood draws, genetic tests, and saving samples for future research.
  • Speak the test language fluently and score 16 to 30 on the MMSE, a memory and thinking test.
  • Agree to be contacted about future research studies.
  • For the follow-up study: finish the main study and agree to calls every 3 months, yearly clinic visits, and yearly amyloid and tau PET scans.

Who can't join

  • Cannot safely have MRI or PET scans, including due to pregnancy, reactions to scan drugs, trouble accessing veins, or too much radiation exposure; or had a negative amyloid PET scan in the past 6 months.
  • Had a stroke or seizure in the past year, or have another brain or nerve disorder that affects thinking. Cancer in the past 5 years also rules you out, except non-melanoma skin cancer or prostate cancer that has not spread beyond where it started.
  • Have serious or unstable health problems, untreated conditions that may affect thinking, HIV not controlled with antiviral medicine, or weigh less than 110 pounds.
  • Had alcohol or drug abuse or dependence in the past year; have unstable mental health symptoms; or score 8 or higher on the depression test and the study doctor finds significant depression.
  • Had recent thinking tests that may make repeat testing easier, score above the study's limit on a word-learning test, or cannot complete testing because of vision or hearing problems.
  • Received a treatment meant to change the course of Alzheimer's disease in the past 6 months. For the follow-up study, you cannot be in or plan to join a trial of such treatment, or plan to use approved medicines of this kind outside research.
  • Work directly for the study sponsor or a participating study site, or are a family member of a direct employee at a study site.
  • For the RetiSpec eye scan: cannot safely use, or are allergic to, tropicamide 1% eye drops, which widen the pupils.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (22)

FL

IL

MI

NV

NY

OH

PA

RI

TX