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

Plain English Summary

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 is a Not Applicable clinical trial sponsored by GAP Innovations, PBC studying Mild Cognitive Impairment, Alzheimer's Disease, Alzheimer's Disease, Early Onset, Memory Loss, Memory Disorders, Memory Impairment. This study is testing if simple blood and digital measurements can predict changes in the brain related to Alzheimer's disease. It is for older adults (60-90 years old) who are cognitively normal, have mild cognitive impairment, or have mild to moderate Alzheimer's dementia. Participation involves blood draws, brain imaging (PET and MRI scans), and cognitive tests, with a study partner needed to help provide information. Currently, definitive diagnosis of Alzheimer's brain changes often requires invasive procedures or expensive imaging; this study aims to find less invasive predictors. The trial aims to enroll 1200 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 60 and 90 years old and have a reliable study partner who can provide regular updates on your health. You must be willing to undergo brain scans (MRI and PET) and provide blood samples. You cannot join if you have had a stroke or seizures in the last year, have certain cancers within the last 5 years, or have conditions that would prevent you from having an MRI or PET scan. Individuals with significant depression or other neurological disorders (besides Alzheimer's) that could affect cognitive function may not be eligible. This trial is studying Mild Cognitive Impairment, Alzheimer's Disease, Alzheimer's Disease, Early Onset, Memory Loss, Memory Disorders, Memory Impairment, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will help determine if specific markers in your blood or digital data can accurately reflect the presence of tau and amyloid proteins in your brain, which are key indicato The specific primary outcome measures are: Biomarkers and PET (Through study completion, an average of 3 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it aims to develop easier and more accessible ways to detect early signs of Alzheimer's disease by correlating blood and digital markers with brain imaging, potentially fill This research targets Mild Cognitive Impairment, Alzheimer's Disease, Alzheimer's Disease, Early Onset, Memory Loss, Memory Disorders, Memory Impairment, where improved treatment options are needed.

Investor Insight

This observational study is building a valuable database for Alzheimer's research, which could support the development of future diagnostic tools, a significant market given the growing prevalence of The large enrollment target of 1200 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if your current health conditions might affect your ability to participate in the study or undergo the required scans. Be prepared for multiple visits, including blood draws, cognitive assessments, and brain imaging (MRI and PET scans). Ensure your study partner understands their role in providing information about your daily functioning and cognitive status. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 1,200 participants

Interventions

• 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. So
• 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.

Primary Outcomes

• Biomarkers and PET (Through study completion, an average of 3 years)

Full 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;

Trial Locations

• JEM Research Institute, Atlantis, Florida, United States
• Visionary Investigators Network, Aventura, Florida, United States
• K2 - Winter Garden, Clermont, Florida, United States
• Brain Matters Research, Delray Beach, Florida, United States
• Neuropsychiatric Research Center of SW Florida, Fort Myers, Florida, United States
• K2 Medical Research, Maitland, Florida, United States
• Clincloud, Melbourne, Florida, United States
• Visionary Investigators Network, Miami, Florida, United States
• Charter Research, Orlando, Florida, United States
• Progressive Medical Research, Port Orange, Florida, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Alzheimer's Disease
• Mild Cognitive Impairment
• Dementia
• Memory Loss
• Cognitive Decline
• Neurodegenerative Diseases
• Aging
• Brain Health
• Biomarker Discovery
• Diagnostic Imaging

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