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Can a simple blood test or phone app spot Alzheimer's early?

NCT ID NCT06584357

Knowledge-focused Sponsor: GAP Innovations, PBC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is creating a large database of blood tests, digital assessments (like smartphone tasks), and brain scans from 1,200 older adults. Participants may have normal memory, mild memory problems, or mild-to-moderate Alzheimer's. The goal is to see if simple, non-invasive tests can predict the buildup of harmful proteins in the brain, which could lead to earlier and easier diagnosis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Up to 1,200 participants will complete all the activities of the protocol over an 18-month competitive enrollment period. Each site will be expected to enroll approximately 40 participants. Approximately 25% of the total participants enrolled will be from underrepresented populations. Enrolled participants will be characterized as fitting into one of three cohorts with approximately 1/3 enrollment in each cohort. While we have outlined cohort criteria below, ultimately it is up to the site principal investigator to determine cohort placement. Cohort status will not be shared with participants.

Ages

60 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Pre-screening Inclusion Criteria Participants must meet ALL of the following criteria to progress to Visit 1 (Screening): 1. Participant is between 60 to 90 years of age (inclusive) at the time of consent; and 2. 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: 1. 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; 2. 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; 3. 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; 4. Fluency in the language of the tests used at the study site; 5. Participants must be willing to be contacted for possible participation in clinical research trials once their participation in this study ends; and 6. Participants must have a Mini-Mental State Exam (MMSE) score of 16 to 30 inclusive at screening. Exclusion Criteria: Pre-screening Exclusion Criteria Participants who meet ANY of the following criteria will not be eligible to progress to Visit 1 (Screening): 1. Participant is unable to undergo amyloid and tau PET scans due to self-reported pregnancy, sensitivity to 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; 2. Participants who have reported or have a known negative amyloid PET scan in the past 6 months; 3. Participants with any known contraindication to brain MRI scan; 4. Participants with history of stroke or seizures within 1 year of the Pre-Screening Visit; 5. Participants with history of cancer within the past 5 years with the exception of non-melanoma skin cancer or prostate cancer in situ; 6. Participants with known or suspected alcohol or drug abuse or dependence within 1 year of the Pre- Screening Visit; 7. Participants who report any current unstable psychiatric symptoms that could interfere with study procedures or impact study data (e.g., uncontrolled depression); 8. Participants who have received any potential disease modifying AD treatment within 6 months prior to the Pre-screening Visit; and 9. Participants with known history or self-report to be Human Immunodeficiency Virus (HIV) Positive unless controlled by antiviral medication. Core Study Exclusion Criteria Participants who meet ANY of the following criteria, in addition to the Pre-screening Exclusion Criteria, will not be eligible to enroll into the study: 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 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; 4. Participants who have completed cognitive testing within 1 month of Visit 1 (Screening) where the Site Principal Investigator believes the participant's exposure may cause practice effect; 5. Participants who have any neurological disorder affecting the central nervous system, other than AD, that may be contributing to cognitive impairment (e.g., Parkinson's disease, other dementias, multiple concussions or seizures) as deemed significant by the Site Principal Investigator; 6. Participants with a Geriatric Depression Scale (GDS) score greater than or equal to 8 at Visit 1 (Screening) and is deemed to be clinically significantly depressed by the Site Principal Investigator; 7. Participants with a Rey Auditory Verbal Learning Test (RAVLT) t-score of ≥ 1.2 standard deviation above the mean. For non-African Americans, calculate age-sex-education adjusted t-scores. For African American participants, use the MOANS to calculate the age-education adjusted t-scores; 8. Participants weighing less than 110 pounds; 9. Participants who are direct employees or family members of direct employees of the participating investigators' sites; 10. Participants who are direct employees of the Sponsor; 11. Participants who, in the opinion of the investigator, are unable to complete cognitive testing due to inadequate visual or auditory acuity; and 12. For participants completing the RetiSpec retinal scan: Those with a known history of contraindication or allergy to Tropicamide 1% (pupil dilation drop). Longitudinal Sub-Study Eligibility Inclusion Criteria: Participants must meet ALL of the following criteria for entry into the sub-study: 1. Participants who completed the Bio-Hermes-002 Core Study; 2. Are willing to complete phone call visits with site staff every three months and return to the clinic for an annual evaluation; and 3. Are willing to complete annual PET scans for both amyloid and tau scans. Exclusion Criteria: Participants who meet ANY of the following criteria will not be eligible for entry into the sub-study: 1. Those who are enrolled or intend to enroll into a clinical trial for Alzheimer's disease with a potential disease-modifying intervention; 2. Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial; 3. Those who intend to use medications outside clinical research studies approved by regulatory authorities to modify Alzheimer's disease pathology.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease cognitive disorder Cognitive Dysfunction familial Alzheimer disease Memory Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease Alzheimer's disease, early onset Memory disorders Memory impairment Memory loss Mild cognitive impairment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    23 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ADRC of Albany

    COMPLETED

    Albany, New York, 12208, United States

  • Axiom Brain Health

    RECRUITING

    Tampa, Florida, 33609, United States

  • Brain Matters Research

    RECRUITING

    Delray Beach, Florida, 33445, United States

    Contact Email: •••••@•••••

  • Charter Research

    RECRUITING

    Orlando, Florida, 32803, United States

  • Clincloud

    RECRUITING

    Melbourne, Florida, 32940, United States

  • Clinical Neurology Specialists

    RECRUITING

    Las Vegas, Nevada, 89147, United States

    Contact Email: •••••@•••••

  • Conquest Research

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Dementia Research Centre, UCLH

    RECRUITING

    London, WC1N 3BG, United Kingdom

  • Flourish Research - Chicago

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Flourish Research - Philadelphia

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19462, United States

  • Gadolin Research LLC

    RECRUITING

    Beaumont, Texas, 77702, United States

  • Intercoastal Medical Group, Inc.

    RECRUITING

    Sarasota, Florida, 34239, United States

  • JEM Research Institute

    RECRUITING

    Atlantis, Florida, 33462, United States

  • K2 - Winter Garden

    RECRUITING

    Clermont, Florida, 34711, United States

  • K2 Medical Research

    RECRUITING

    Maitland, Florida, 32751, United States

  • K2 Medical Research

    RECRUITING

    East Providence, Rhode Island, 02914, United States

  • Neuro-Behavioral Clinical Research Inc.

    COMPLETED

    North Canton, Ohio, 44720, United States

  • NeuroClin Glasgow

    RECRUITING

    Motherwell, North Lanarkshire, ML1 4UF, United Kingdom

  • Neuropsychiatric Research Center of SW Florida

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • Progressive Medical Research

    RECRUITING

    Port Orange, Florida, 32127, United States

  • Quest Research Institute

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Re:Cognition Health

    RECRUITING

    Houston, Texas, 77030, United States

  • Re:Cognition Health

    RECRUITING

    London, W1G 8TA, United Kingdom

  • Toronto Memory Program

    RECRUITING

    Toronto, Ontario, M3B 2S7, Canada

  • Visionary Investigators Network

    RECRUITING

    Aventura, Florida, 33180, United States

  • Visionary Investigators Network

    RECRUITING

    Miami, Florida, 33133, United States

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