1200 Participants Needed

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

(Bio-Hermes-002 Trial)

Recruiting at 18 trial locations
AN
JG
Overseen ByJenn Gaudioso, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have given or my representative has given written consent for me to participate.
I meet the main requirements to participate in the study.
I agree to follow the study's procedures, including giving blood samples and allowing my genetic information and samples to be stored for future research.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants undergo blood, CSF, retinal, digital, MRI, and PET brain imaging to collect biomarker data

120 days

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Mild-to-Moderate AD DementiaExperimental Treatment2 Interventions
A diagnosis of Mild-to-Moderate AD Dementia based on the National Institute of Aging (NIA) criteria and verified through medical records.
Group II: Mild Cognitive ImpairmentExperimental Treatment2 Interventions
A diagnosis of Mild Cognitive Impairment (MCI) based on the National Institute of Aging (NIA) criteria and verified through medical records.
Group III: Cognitively NormalExperimental Treatment2 Interventions
No reported memory loss or concerns as reported by participant and study partner.

Find a Clinic Near You

Who Is Running the Clinical Trial?

GAP Innovations, PBC

Lead Sponsor

Trials
2
Recruited
2,200+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
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