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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Other, Radiation
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 90
Healthy Volunteers: t
View:

⁃ Pre-screening Inclusion Criteria

⁃ Participants must meet ALL of the following criteria to progress to Visit 1 (Screening):

• Participant is between 60 to 90 years of age (inclusive) at the time of consent; and

• 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:

• 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;

• 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;

• 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;

• Fluency in the language of the tests used at the study site;

• Participants must be willing to be contacted for possible participation in clinical research trials once their participation in this study ends; and

• Participants must have a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusive at screening.

⁃ Participants must meet ALL of the following criteria for entry into the sub-study:

• Participants who completed the Bio-Hermes-002 Core Study;

• Are willing to complete phone call visits with site staff every three months and return to the clinic for an annual evaluation; and

• Are willing to complete annual PET scans for both amyloid and tau scans.

Locations
United States
Florida
JEM Research Institute
RECRUITING
Atlantis
Visionary Investigators Network
RECRUITING
Aventura
K2 - Winter Garden
RECRUITING
Clermont
Brain Matters Research
RECRUITING
Delray Beach
Neuropsychiatric Research Center of SW Florida
RECRUITING
Fort Myers
K2 Medical Research
RECRUITING
Maitland
Clincloud
RECRUITING
Melbourne
Visionary Investigators Network
RECRUITING
Miami
Charter Research
RECRUITING
Orlando
Progressive Medical Research
RECRUITING
Port Orange
Intercoastal Medical Group, Inc.
RECRUITING
Sarasota
Axiom Brain Health
RECRUITING
Tampa
Conquest Research
RECRUITING
Winter Park
Illinois
Flourish Research - Chicago
RECRUITING
Chicago
Michigan
Quest Research Institute
RECRUITING
Farmington Hills
New York
ADRC of Albany
COMPLETED
Albany
Ohio
Neuro-Behavioral Clinical Research Inc.
RECRUITING
North Canton
Pennsylvania
Flourish Research - Philadelphia
RECRUITING
Philadelphia
Texas
Gadolin Research LLC
RECRUITING
Beaumont
Re:Cognition Health
RECRUITING
Houston
Other Locations
Canada
Toronto Memory Program
RECRUITING
Toronto
United Kingdom
Re:Cognition Health
RECRUITING
London
NeuroClin Glasgow
RECRUITING
Motherwell
Contact Information
Primary
Amanda Ng, MA
biohermes-002@globalalzplatform.org
biohermes-002@globalalzplatfor
Time Frame
Start Date: 2024-09-26
Estimated Completion Date: 2028-07
Participants
Target number of participants: 1200
Treatments
Cognitively Normal
No reported memory loss or concerns as reported by participant and study partner.
Mild Cognitive Impairment
A diagnosis of Mild Cognitive Impairment (MCI) based on the National Institute of Aging (NIA) criteria and verified through medical records.
Mild-to-Moderate AD Dementia
A diagnosis of Mild-to-Moderate AD Dementia based on the National Institute of Aging (NIA) criteria and verified through medical records.
Sponsors
Leads: GAP Innovations, PBC

This content was sourced from clinicaltrials.gov