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

Last updated: February 3, 2025
Sponsor: Global Alzheimer's Platform Foundation
Overall Status: Completed

Phase

N/A

Condition

Mild Cognitive Impairment

Memory Loss

Learning Disorders

Treatment

Prescreener database

Clinical Study ID

NCT05364307
Apheleia-001
  • Ages 50-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants and/or a legally authorized representative (LAR) must providesigned and dated informed consent and authorization to use personal healthinformation 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 28inclusive;

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

  5. Participants must be willing to comply with all procedures as outlined in theinformed consent, including blood sampling, genetic testing, and storage ofbiospecimens 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

Exclusion Criteria:

  1. Participants who, in the opinion of the Investigator, have serious or unstablemedical conditions that would prohibit their completion of all prescreeningprocedures and data collection;

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

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

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

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

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

  7. Participants with a history or evidence of a malignancy within the 2 yearsprior to prescreening. Subjects with indolent malignancies (e.g., basal cellcarcinoma or squamous cell carcinoma) or malignancies considered to be curedand not actively treated with anti-cancer therapy or radiotherapy are permittedto 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 diseasemodifying AD treatment and received active drug within 6 months prior toprescreening;

  11. Participants who have any neurological disorder affecting the central nervoussystem, other than AD, that may be contributing to cognitive impairment (e.g.,Parkinson's disease, other dementias, multiple concussions or seizures) asdeemed significant by the Investigator;

  12. Participants with known history of hepatitis C virus, hepatitis B virus, humanimmunodeficiency 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 amAb, or immunoglobulin therapy;

  15. Participants with allergies to diphenhydramine, epinephrine, andmethylprednisolone;

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

  17. Participants who are direct employees of the Sponsor;

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

Study Design

Total Participants: 1555
Treatment Group(s): 1
Primary Treatment: Prescreener database
Phase:
Study Start date:
June 13, 2022
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • OCT Research

    Kelowna, British Colombia V1V 1Z9
    Canada

    Site Not Available

  • Pacific Research Network

    San Diego, California 92103
    United States

    Site Not Available

  • Syrentis Clinical Research

    Santa Ana, California 92705
    United States

    Site Not Available

  • Visionary Investigator's Network

    Aventura, Florida 33180
    United States

    Site Not Available

  • Charter Research

    Lady Lake, Florida 32159
    United States

    Site Not Available

  • JEM Research Institute

    Lake Worth, Florida 33462
    United States

    Site Not Available

  • ClinCloud, LLC

    Maitland, Florida 32751
    United States

    Site Not Available

  • K2 Medical Research

    Maitland, Florida 32751
    United States

    Site Not Available

  • Merritt Island Medical Research

    Merritt Island, Florida 32952
    United States

    Site Not Available

  • Renstar Medical Research

    Ocala, Florida 34471
    United States

    Site Not Available

  • ClinCloud, LLC

    Viera, Florida 32940
    United States

    Site Not Available

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Charter Research

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Conquest Research

    Winter Park, Florida 32789
    United States

    Site Not Available

  • iResearch

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • IPS Research

    Oklahoma City, Oklahoma 73106
    United States

    Site Not Available

  • Clinical Trials of Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Re:Cognition Health

    Fairfax, Virginia 22031
    United States

    Site Not Available

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