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

December 28, 2022 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

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

Study Contact

Study Locations

  • Canada
    • British Colombia
      • Kelowna, British Colombia, Canada, V1V 1Z9
        • Not yet recruiting
        • OCT Research
        • Contact:
          • Robert Goldberg
          • Phone Number: 250-862-8141
  • United States
    • California
      • San Diego, California, United States, 92103
        • Recruiting
        • Pacific Research Network
        • Contact:
          • Lauren Martinez
          • Phone Number: 619-294-4302
        • Contact:
          • Shanisha Miller
          • Phone Number: 619-294-4302
      • Santa Ana, California, United States, 92705
        • Recruiting
        • Syrentis Clinical Research
        • Contact:
          • Marlene Preyer
          • Phone Number: 714-542-3008
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Visionary Investigator's Network
        • Contact:
          • Jose Macias
          • Phone Number: 305-933-5993
      • Lady Lake, Florida, United States, 32159
        • Recruiting
        • Charter Research
        • Contact:
          • Rachel Nix
          • Phone Number: 352-775-1000
        • Contact:
          • Kisha Kaffenberger
          • Phone Number: 352-775-1000
      • Lake Worth, Florida, United States, 33462
        • Recruiting
        • JEM Research Institute
        • Contact:
          • Janette Bossaers
          • Phone Number: 561-968-2933
      • Maitland, Florida, United States, 32751
        • Recruiting
        • ClinCloud, LLC
        • Contact:
          • Valery Crespo-Matos
          • Phone Number: 407-636-4031
        • Contact:
          • Angel Perez
          • Phone Number: 407-636-4031
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research
        • Contact:
          • Jawad Alqerem
          • Phone Number: 407-500-5252
      • Merritt Island, Florida, United States, 32952
        • Recruiting
        • Merritt Island Medical Research
        • Contact:
          • Joshua Mabry
          • Phone Number: 321-305-5015
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Renstar Medical Research
        • Contact:
          • Mandy Roomy
          • Phone Number: 352-629-5800
        • Contact:
          • Allison Morgan
          • Phone Number: 352-629-5800
      • Viera, Florida, United States, 32940
        • Recruiting
        • ClinCloud, LLC
        • Contact:
          • Mariah Robison
          • Phone Number: 407-680-0534
        • Contact:
          • Anna Manturova
          • Phone Number: 407-680-0534
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Premiere Research Institute at Palm Beach Neurology
        • Contact:
          • Colleen Reiser
          • Phone Number: 561-845-0500
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research
        • Contact:
          • Melissa O'Neill
          • Phone Number: 407-848-3845
      • Winter Park, Florida, United States, 32792
        • Recruiting
        • Charter Research
        • Contact:
          • Helen Martinez
          • Phone Number: 407-337-1000
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • IResearch
        • Contact:
          • Jessica Certain
          • Phone Number: 404-537-1281
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Quest Research Institute
        • Contact:
          • Linda Bardram
          • Phone Number: 248-957-8940
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73106
        • Not yet recruiting
        • IPS Research
        • Contact:
          • Lori Moore
          • Phone Number: 405-235-8188
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Clinical Trials of Texas
        • Contact:
          • Jamie Padilla
          • Phone Number: 210-949-0122
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Re:Cognition Health
        • Contact:
          • Victoria Wu
          • Phone Number: 703-520-9703
        • Contact:
          • Monica Bland
          • Phone Number: 703-520-9703

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

Genders Eligible for Study

All

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 (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

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 (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

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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