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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)

N/A
Recruiting
Research Sponsored by GAP Innovations, PBC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Memory Disorders
  • Alzheimer's Disease
  • Memory Loss
  • Mild Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Biomarkers and PET

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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Who is running the clinical trial?

GAP Innovations, PBCLead Sponsor
1 Previous Clinical Trials
1,002 Total Patients Enrolled
1 Trials studying Memory Disorders
1,002 Patients Enrolled for Memory Disorders
~800 spots leftby Jul 2028
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