Clinical trial NCT05364307: Identification of Patients With a High Probability of Meeting Eligibility Criteria for an Alzheimer's Disease Clinical Trial (APHELEIA)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: Global Alzheimer's Platform Foundation
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 1555
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 3,000 participants.

Brief 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 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.

Primary outcomes:
measure: Determine number of patients eligible for therapeutic Alzheimer's Disease clinical trial
timeFrame: Throughout study completion, an average of 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Aventura
country: United States
facility: Visionary Investigator's Network
state: Florida
city: Lady Lake
country: United States
facility: Charter Research
state: Florida
city: Lake Worth
country: United States
facility: JEM Research Institute
state: Florida
city: Maitland
country: United States
facility: ClinCloud, LLC
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Merritt Island
country: United States
facility: Merritt Island Medical Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Viera
country: United States
facility: ClinCloud, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Winter Park
country: United States
facility: Charter Research
state: Florida
city: Decatur
country: United States
facility: iResearch
state: Georgia
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Fairfax
country: United States
facility: Re:Cognition Health
state: Virginia
city: Kelowna
country: Canada
facility: OCT Research
state: British Colombia
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.