Actively Recruiting
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
Led by GAP Innovations, PBC · Updated on 2026-04-15
1200
Participants Needed
26
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 60 to 90 years old at consent
- Participants must have a study partner with at least 8 hours of weekly contact able to report on cognitive and functional abilities
- Written consent must be provided by participant or legally authorized representative
- Willingness to undergo MRI brain scan within 90 days and amyloid and tau PET scans within 120 days of consent
- Willingness to comply with study procedures including blood sampling, genetic testing, and biospecimen storage
- Fluency in the language used at the study site
- Willingness to be contacted for future clinical research participation
- Mini-Mental State Exam score between 16 and 30 inclusive at screening
You will not qualify if you...
- Unable to undergo amyloid and tau PET scans due to pregnancy, ligand sensitivity, poor venous access, contraindications, or excessive radiation exposure
- Known negative amyloid PET scan in past 6 months
- Contraindications to brain MRI
- History of stroke or seizures within 1 year before screening
- History of cancer within past 5 years except non-melanoma skin cancer or prostate cancer in situ
- Known or suspected alcohol or drug abuse within 1 year before screening
- Current unstable psychiatric symptoms interfering with study
- Use of disease-modifying Alzheimer's treatments within 6 months prior to screening
- Known HIV positive status unless controlled by medication
- Serious or unstable medical conditions preventing study completion
- Untreated vitamin B12 or folate deficiency or bladder infections that may affect cognition
- Cognitive testing within 1 month before screening that could cause practice effect
- Neurological disorders other than Alzheimer's that affect cognition
- Geriatric Depression Scale score 8 or higher with clinical depression
- Rey Auditory Verbal Learning Test t-score 1.2 standard deviations above mean
- Weigh less than 110 pounds
- Direct employee or family member of study site investigators or sponsor
- Inability to complete cognitive tests due to poor vision or hearing
- Known allergy or contraindication to pupil dilation drops for retinal scan
- Enrollment in Alzheimer's clinical trials with disease-modifying treatments
- Intention to use Alzheimer's medications outside approved clinical studies
- Serious or unstable medical conditions precluding interventional research participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
JEM Research Institute
Atlantis, Florida, United States, 33462
Actively Recruiting
2
Visionary Investigators Network
Aventura, Florida, United States, 33180
Actively Recruiting
3
K2 - Winter Garden
Clermont, Florida, United States, 34711
Actively Recruiting
4
Brain Matters Research
Delray Beach, Florida, United States, 33445
Actively Recruiting
5
Neuropsychiatric Research Center of SW Florida
Fort Myers, Florida, United States, 33912
Actively Recruiting
6
K2 Medical Research
Maitland, Florida, United States, 32751
Actively Recruiting
7
Clincloud
Melbourne, Florida, United States, 32940
Actively Recruiting
8
Visionary Investigators Network
Miami, Florida, United States, 33133
Actively Recruiting
9
Charter Research
Orlando, Florida, United States, 32803
Actively Recruiting
10
Progressive Medical Research
Port Orange, Florida, United States, 32127
Actively Recruiting
11
Intercoastal Medical Group, Inc.
Sarasota, Florida, United States, 34239
Actively Recruiting
12
Axiom Brain Health
Tampa, Florida, United States, 33609
Actively Recruiting
13
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
14
Flourish Research - Chicago
Chicago, Illinois, United States, 60640
Actively Recruiting
15
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
16
Clinical Neurology Specialists
Las Vegas, Nevada, United States, 89147
Actively Recruiting
17
ADRC of Albany
Albany, New York, United States, 12208
Completed
18
Neuro-Behavioral Clinical Research Inc.
North Canton, Ohio, United States, 44720
Completed
19
Flourish Research - Philadelphia
Philadelphia, Pennsylvania, United States, 19462
Active, Not Recruiting
20
K2 Medical Research
East Providence, Rhode Island, United States, 02914
Actively Recruiting
21
Gadolin Research LLC
Beaumont, Texas, United States, 77702
Actively Recruiting
22
Re:Cognition Health
Houston, Texas, United States, 77030
Actively Recruiting
23
Toronto Memory Program
Toronto, Ontario, Canada, M3B 2S7
Actively Recruiting
24
NeuroClin Glasgow
Motherwell, North Lanarkshire, United Kingdom, ML1 4UF
Actively Recruiting
25
Re:Cognition Health
London, United Kingdom, W1G 8TA
Actively Recruiting
26
Dementia Research Centre, UCLH
London, United Kingdom, WC1N 3BG
Actively Recruiting
Research Team
A
Amanda Ng, MA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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