Clinical trial NCT06584357: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: GAP Innovations, PBC
Sponsor class: INDUSTRY
First posted: 2024-09-04
Enrollment: 1200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.


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.

Primary outcomes:
measure: Biomarkers and PET
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Aventura
country: United States
facility: Visionary Investigators Network
state: Florida
city: Clermont
country: United States
facility: K2 - Winter Garden
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of SW Florida
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Melbourne
country: United States
facility: Clincloud
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: Orlando
country: United States
facility: Charter Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group, Inc.
state: Florida
city: Tampa
country: United States
facility: Axiom Brain Health
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Chicago
country: United States
facility: Flourish Research - Chicago
state: Illinois
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Albany
country: United States
facility: ADRC of Albany
state: New York
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research Inc.
state: Ohio
city: Philadelphia
country: United States
facility: Flourish Research - Philadelphia
state: Pennsylvania
city: Beaumont
country: United States
facility: Gadolin Research LLC
state: Texas
Study officials:
References: