ClinicalTrials.gg
CompletedNCT05364307Updated Feb 5, 2025

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

An observational study in Alzheimer Disease, Mild Cognitive Impairment and Memory Loss, sponsored by Global Alzheimer's Platform Foundation. Completed at 19 sites in 2 countries. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-02-05.

Sponsored by Global Alzheimer's Platform Foundation · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,555
Ages
50 Years to 90 Years
Sex
All
01

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.

02

Conditions studied

  • Alzheimer Disease
  • Mild Cognitive Impairment
  • Memory Loss
  • Memory Disorders
  • Memory Impairment

Keywords

  • Alzheimer's Disease
  • Memory Loss
  • Memory Disorder
  • Mild Cognitive Impairment
  • Early Alzheimer's Disease
03

In context

Alzheimer Disease

3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.

This study's enrollment of 1,555 is above the median of 200 across 780 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

This is the only study on the registry with Global Alzheimer's Platform Foundation as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Approximately 3,000 participants.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,555 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherPrescreener database

    Identify and characterize participants with reported memory complaints and/or cognitive impairment to determine the probability of randomization into a therapeutic AD clinical trial.

06

What researchers measure

Primary outcomes

  1. Determine number of patients eligible for therapeutic Alzheimer's Disease clinical trial

    Participants with reported memory complaints and/or cognitive impairment will provide demographic information, clinical history, complete brief cognitive assessments, and provide blood-based biomarkers

    Time frame: Throughout study completion, an average of 45 days

07

Study locations

19 sites
  • Pacific Research Network
    San Diego, California 92103, United States
  • Syrentis Clinical Research
    Santa Ana, California 92705, United States
  • Visionary Investigator's Network
    Aventura, Florida 33180, United States
  • Charter Research
    Lady Lake, Florida 32159, United States
  • JEM Research Institute
    Lake Worth, Florida 33462, United States
  • ClinCloud, LLC
    Maitland, Florida 32751, United States
  • K2 Medical Research
    Maitland, Florida 32751, United States
  • Merritt Island Medical Research
    Merritt Island, Florida 32952, United States
  • Renstar Medical Research
    Ocala, Florida 34471, United States
  • ClinCloud, LLC
    Viera, Florida 32940, United States
  • Premiere Research Institute at Palm Beach Neurology
    West Palm Beach, Florida 33407, United States
  • Conquest Research
    Winter Park, Florida 32789, United States
  • Charter Research
    Winter Park, Florida 32792, United States
  • iResearch
    Decatur, Georgia 30030, United States
  • Quest Research Institute
    Farmington Hills, Michigan 48334, United States
  • IPS Research
    Oklahoma City, Oklahoma 73106, United States
  • Clinical Trials of Texas
    San Antonio, Texas 78229, United States
  • Re:Cognition Health
    Fairfax, Virginia 22031, United States
  • OCT Research
    Kelowna, British Colombia V1V 1Z9, Canada
08

References and documents

Publications

  • Baek MJ, Kim K, Park YH, Kim S. The Validity and Reliability of the Mini-Mental State Examination-2 for Detecting Mild Cognitive Impairment and Alzheimer's Disease in a Korean Population. PLoS One. 2016 Sep 26;11(9):e0163792. doi: 10.1371/journal.pone.0163792. eCollection 2016. PubMed 27668883 ↗
  • Berry CC. A tutorial on confidence intervals for proportions in diagnostic radiology. AJR Am J Roentgenol. 1990 Mar;154(3):477-80. doi: 10.2214/ajr.154.3.2106207. No abstract available. PubMed 2106207 ↗
  • Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018. PubMed 29653606 ↗
  • Kantarci K. Molecular imaging of Alzheimer disease pathology. AJNR Am J Neuroradiol. 2014 Jun;35(6 Suppl):S12-7. doi: 10.3174/ajnr.A3847. Epub 2014 Feb 6. PubMed 24503555 ↗
  • Niemantsverdriet E, Valckx S, Bjerke M, Engelborghs S. Alzheimer's disease CSF biomarkers: clinical indications and rational use. Acta Neurol Belg. 2017 Sep;117(3):591-602. doi: 10.1007/s13760-017-0816-5. Epub 2017 Jul 27. PubMed 28752420 ↗
  • O'Bryant SE, Humphreys JD, Smith GE, Ivnik RJ, Graff-Radford NR, Petersen RC, Lucas JA. Detecting dementia with the mini-mental state examination in highly educated individuals. Arch Neurol. 2008 Jul;65(7):963-7. doi: 10.1001/archneur.65.7.963. PubMed 18625866 ↗
  • Jannati A, Toro-Serey C, Ciesla M, Chen E, Showalter J, Bates D, Pascual-Leone A, Tobyne S. Streamlining eligibility assessment for Alzheimer's disease-modifying therapies: Prediction of MMSE scores using the digital clock and recall. Front Digit Health. 2026 Jul 9;8:1799372. doi: 10.3389/fdgth.2026.1799372. eCollection 2026. PubMed 42495050 ↗
  • Jannati A, Toro-Serey C, Ciesla M, Chen E, Showalter J, Bates D, Pascual-Leone A, Tobyne S. Streamlining Eligibility Assessment for Alzheimer's Disease-Modifying Therapies: Prediction of MMSE Scores Using the Digital Clock and Recall. medRxiv [Preprint]. 2026 Mar 4:2026.03.03.26347542. doi: 10.64898/2026.03.03.26347542. PubMed 41867219 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in Jan 2025, 31 months.

Of 351 non-industry observational studies under Alzheimer Disease, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 203. This study's 31 months is below that.

Counting every sponsor, half of 387 studies reached it within 67 months; a quarter within 36 and three quarters within 140.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2022
First posted
May 6, 2022
StartActual
Jun 13, 2022
Primary completionActual
Jan 31, 2025
CompletionActual
Jan 31, 2025
Last update
Feb 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05364307
Lead sponsor
Global Alzheimer's Platform Foundation
Responsible party
Sponsor
First posted
May 6, 2022
Start date
Jun 13, 2022
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Last update
Feb 5, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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