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Alzheimer DiseaseNCT05364307

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

An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Global Alzheimer's Platform Foundation at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
What is being tested?
Prescreener database
How many people
1,555 participants
Where
19 sitesin 2 countries
Study dates
13 Jun 2022to 31 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Approximately 3,000 participants.

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 18Show fewer
  • 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.

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States18 sites

  • Visionary Investigator's Network

    Aventura, Florida, 33180

  • iResearch

    Decatur, Georgia, 30030

  • Re:Cognition Health

    Fairfax, Virginia, 22031

  • Quest Research Institute

    Farmington Hills, Michigan, 48334

  • Charter Research

    Lady Lake, Florida, 32159

  • JEM Research Institute

    Lake Worth, Florida, 33462

  • ClinCloud, LLC

    Maitland, Florida, 32751

  • K2 Medical Research

    Maitland, Florida, 32751

  • Merritt Island Medical Research

    Merritt Island, Florida, 32952

  • Renstar Medical Research

    Ocala, Florida, 34471

  • IPS Research

    Oklahoma City, Oklahoma, 73106

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

  • Pacific Research Network

    San Diego, California, 92103

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • ClinCloud, LLC

    Viera, Florida, 32940

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

  • Conquest Research

    Winter Park, Florida, 32789

  • Charter Research

    Winter Park, Florida, 32792

Other trials in United States

Canada1 site

  • OCT Research

    Kelowna, British Colombia, V1V 1Z9

Other trials in Canada

About this study

Official title: 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.

Being tested
Prescreener database
Keywords
Alzheimer's Disease, Memory Loss, Memory Disorder, Mild Cognitive Impairment, Early Alzheimer's Disease
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Memory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prescreener databaseOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Throughout study completion, an average of 45 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start13 Jun 2022
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,555 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05364307
Sponsor's protocol ID
Apheleia-001
Status last verified
Feb 2025
First submitted
4 May 2022
Last updated
5 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Global Alzheimer's Platform Foundation at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine number of patients eligible for therapeutic Alzheimer's Disease clinical trial (time frame: Throughout study completion, an average of 45 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05364307, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

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