Alzheimer's Disease, Alzheimer's Disease, Early Onset, Memory Disorders, Memory Impairment, Memory Loss, Mild Cognitive Impairment
Conditions
Keywords
Alzheimer's Disease, Alzheimer's Disease, Early Onset, Mild Cognitive Impairment, Older Volunteers, Healthy Volunteers, Memory Loss, Memory Disorders, Memory Impairment
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.
Interventions
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.
RADIATIONMK6240
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.
Sponsors
GAP Innovations, PBC
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers and PET | 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. |
Countries
Canada, United Kingdom, United States
Contacts
CONTACTAmanda Ng, MA
Outcome results
None listed