Identification of Patients With a High Probability of Meeting Eligibility Criteria for an Alzheimer's Disease Clinical Trial (APHELEIA)

February 3, 2025 updated by: Global Alzheimer's Platform Foundation

Identification of Mild Cognitive Impairment (MCI) and Early Alzheimer's Disease (AD) Patients With a High Probability of Meeting Eligibility Criteria for a Therapeutic Alzheimer's Disease Clinical Trial (APHELEIA)

Apheleia-001 is a prescreener that aims to identify and characterize participants with reported cognitive impairment using demographic information, clinical history, brief cognitive assessments, and blood-based biomarkers to distinguish appropriate participants for referral to a therapeutic AD clinical trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1555

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Colombia
      • Kelowna, British Colombia, Canada, V1V 1Z9
        • OCT Research
  • United States
    • California
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
    • Florida
      • Aventura, Florida, United States, 33180
        • Visionary Investigator's Network
      • Lady Lake, Florida, United States, 32159
        • Charter Research
      • Lake Worth, Florida, United States, 33462
        • JEM Research Institute
      • Maitland, Florida, United States, 32751
        • K2 Medical Research
      • Maitland, Florida, United States, 32751
        • ClinCloud, LLC
      • Merritt Island, Florida, United States, 32952
        • Merritt Island Medical Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Viera, Florida, United States, 32940
        • ClinCloud, LLC
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute at Palm Beach Neurology
      • Winter Park, Florida, United States, 32789
        • Conquest Research
      • Winter Park, Florida, United States, 32792
        • Charter Research
    • Georgia
      • Decatur, Georgia, United States, 30030
        • IResearch
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • IPS Research
    • Texas
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Re:Cognition Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Approximately 3,000 participants.

Description

Inclusion Criteria:

  • 1. Participants and/or a legally authorized representative (LAR) must provide signed and dated informed consent and authorization to use personal health information in accordance with local and national guidance and regulations;

    2. Male or female 50 to 90 years of age (inclusive) at the time of consent;

    3. Participants must have a Mini-Mental State Exam (MMSE) score of 20 to 28 inclusive;

    4. Progressive cognitive complaints must be reported by participant or caregiver;

    5. Participants must be willing to comply with all procedures as outlined in the informed consent, including blood sampling, genetic testing, and storage of biospecimens for future research;

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

    7. Participants must be interested in participating in clinical research.

Exclusion Criteria:

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

    2. Participants who are currently enrolled in another clinical study.

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

    4. Participants who have reported or have a known negative amyloid PET scan in the past 24 months;

    5. Participants with history of stroke within 6 months of prescreening;

    6. Participants with an uncontrolled seizure disorder, unexplained blackouts, OR history of a seizure within 6 months (subjects with a history of pediatric febrile seizure, benign rolandic epilepsy may participate);

    7. Participants with a history or evidence of a malignancy within the 2 years prior to prescreening. Subjects with indolent malignancies (e.g., basal cell carcinoma or squamous cell carcinoma) or malignancies considered to be cured and not actively treated with anti-cancer therapy or radiotherapy are permitted to enroll;

    8. Participants with known or suspected alcohol or drug abuse or dependence within 2 years of prescreening;

    9. Participants with a reported suicidal attempt within 2 years of prescreening), or any unstable psychiatric symptoms (e.g., 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 prescreening;

    11. 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 Investigator;

    12. Participants with known history of hepatitis C virus, hepatitis B virus, human immunodeficiency virus (HIV) or other immunodeficiencies;

    13. Participants that have previously been consented to this protocol;

    14. Participants with a hypersensitivity to mAb treatments, protein derived from a mAb, or immunoglobulin therapy;

    15. Participants with allergies to diphenhydramine, epinephrine, and methylprednisolone;

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

    17. Participants who are direct employees of the Sponsor;

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine number of patients eligible for therapeutic Alzheimer's Disease clinical trial
Time Frame: Throughout study completion, an average of 45 days
Participants with reported memory complaints and/or cognitive impairment will provide demographic information, clinical history, complete brief cognitive assessments, and provide blood-based biomarkers
Throughout study completion, an average of 45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Global Alzheimer's Platform Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2022

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

May 4, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Apheleia-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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