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A Biomarker Database to Investigate Blood-Based and Digital Biomarkers in Participants Screened for Alzheimer's Disease (Bio-Hermes)

Sponsor
GAP Innovations, PBC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04733989
Collaborator
(none)
1,000
Enrollment
13
Locations
19.4
Anticipated Duration (Months)
76.9
Patients Per Site
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study (Bio-Hermes) is to develop a blood, digital, and brain amyloid PET scan biomarker database that can be used to determine whether a meaningful relationship exists between digital tests, blood amyloid-beta, p-tau, and neurofilament biomarker levels and amyloid-beta levels identified through brain amyloid PET images. Blood collected will also be genetically sequenced to gain insights about genes and brain amyloid. The Bio-Hermes study will include 1,000 volunteers over the age of 60 screened for Preclinical Alzheimer's Disease, Prodromal AD, or Mild Dementia AD, and includes an endpoint enrollment requirement of 200 participants from underrepresented minority populations.

Condition or Disease Intervention/Treatment Phase
  • Other: Biomarker Data Collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Development of a Biomarker Database to Investigate Aß, P-tau, and NfL Blood-Based Biomarkers and Digital Biomarkers in Older Participants Screened for Preclinical Alzheimer's Disease (AD), Prodromal AD, or Mild AD
Actual Study Start Date :
Apr 21, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Measurement of each participant's blood-based biomarker (Beta-Amyloid, Phospho-Tau, Neurofilament Light Chain) levels will be collected through blood sampling. [Through study completion, an average of 1 year]

  2. Measurement of each participant's amyloid levels in the brain will be collected through amyloid PET brain scan imaging. [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Participants must provide written consent in the IRB-approved informed consent form or have a Legally Authorized Representative (LAR) provide written consent in the IRB-approved consent form on the participant's behalf;

  2. Male or female 60 to 85 years of age (inclusive) at the time of consent;

  3. Participants must be willing to undergo an amyloid PET scan within 60 days of signing informed consent;

  4. Participants must have a study partner who, in the investigator's judgement, has sufficient and frequent contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities;

  5. Participants must be willing to comply with all study procedures as outlined in the informed consent, including blood sampling;

  6. Fluency in the language of the tests used at the study site;

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

  8. Participants must have an MMSE score of 20 to 30 inclusive at screening.

Exclusion Criteria:

  1. Participants who, in the opinion of the Site Principal Investigator, have serious or unstable medical conditions that would prohibit their completion of all study procedures and data collection;

  2. Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial;

  3. Participants who are unable to undergo amyloid PET due to self-reported pregnancy, sensitivity of ligands being used, poor venous access, contraindication to PET, or planned or recent exposure to ionizing radiation that in combination with the planned administration of amyloid radioligand would result in a cumulative exposure that exceeds recommended local guidelines;

  4. Participants who have reported or have a known negative amyloid PET scan in past 12 months;

  5. Participants with self-reported, untreated conditions such as vitamin B12 or folate deficiency or bladder infections that in the opinion of the Site Principal Investigator could contribute to cognitive impairment;

  6. Participants with history of stroke or seizures within 1 year of the Visit 1 (Screening);

  7. Participants with history of cancer within the past 5 years with the exception of non-melanoma skin cancer or prostate cancer in situ;

  8. Participants with known or suspected alcohol or drug abuse or dependence within 1 year of the Visit 1 (Screening);

  9. Participants who report any current unstable psychiatric symptoms that could interfere with study procedures or impact study data (eg, uncontrolled depression);

  10. Participants who have participated in a clinical trial of any potential disease modifying AD treatment and received active drug within 6 months prior to Visit 1 (Screening);

  11. Participants who have completed clinical or observational study procedures (eg, imaging, cognitive testing) within 3 months of Visit 1 (Screening);

  12. Participants who have any neurological disorder affecting the central nervous system, other than AD, that may be contributing to cognitive impairment (eg, Parkinson's disease, other dementias, multiple concussions or seizures) as deemed significant by the Site Principal Investigator;

  13. Participants with a Geriatric Depression Scale (GDS) score greater than or equal to 8 at Visit 1 (Screening);

  14. Participants with a RAVLT-Delayed Recall Score of 1.5 standard deviation above the age-adjusted mean;

  15. Participants with known history or self-report to be Human Immunodeficiency Virus (HIV) Positive;

  16. Participants weighing less than 110 pounds;

  17. Participants that have previously been consented to this study;

  18. Participants who are direct employees or family members of direct employees of the participating investigators' sites;

  19. Participants who are direct employees of the Sponsor;

  20. Participants who, in the opinion of the investigator, are unable to complete cognitive testing due to inadequate visual or auditory acuity;

  21. For participants of the RetiSpec retinal substudy only: Those with a known history of ocular diseases (such as retinopathy, age-related macular degeneration, and glaucoma), with the exception of mild to moderate cataracts, and/or vision correction with glasses/contact lenses.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Visionary Investigators Aventura Florida United States 33180
2 Charter Research - Lady Lake Lady Lake Florida United States 32159
3 JEM Lake Worth Florida United States 33462
4 ClinCloud Maitland Florida United States 32751
5 K2 Orlando Florida United States 32751
6 Progressive Medical Research Port Orange Florida United States 32127
7 Axiom Clinical Research of Florida Tampa Florida United States 33609
8 Charter Research - Winter Park Winter Park Florida United States 32792
9 Great Lakes Clinical Trials Chicago Illinois United States 60640
10 Kansas University Alzheimer's Disease Center (KUADC) Fairway Kansas United States 66160
11 Velocity Clinical Research - Syracuse Syracuse New York United States 13057
12 Kerwin Research Center Dallas Texas United States 75231
13 El Faro Health and Therapeutics Rio Grande City Texas United States 78582

Sponsors and Collaborators

  • GAP Innovations, PBC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
GAP Innovations, PBC
ClinicalTrials.gov Identifier:
NCT04733989
Other Study ID Numbers:
  • BIO-HERMES-001
First Posted:
Feb 2, 2021
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GAP Innovations, PBC
Alzheimer's disease
Alzheimer Disease, Early Onset
Mild Cognitive Impairment
Memory Loss
Memory Disorders
Memory Impairment
Older Volunteers
Healthy Volunteers
Additional relevant MeSH terms:
Alzheimer Disease
Memory Disorders
Amnesia
Cognitive Dysfunction

Study Results

No Results Posted as of Aug 2, 2022