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

NCT05364307 | Completed

• 1 other identifier: Apheleia-001
• Study Type: observational
• Target: 1,555
• Locations: 2 countries
• Sites: 19

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.

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

Outcome Measures

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

  Throughout study completion, an average of 45 days

Interventions

Prescreener database OTHER

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

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 3,000 participants.

You may qualify if:

• \. 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;
• \. Male or female 50 to 90 years of age (inclusive) at the time of consent;
• \. Participants must have a Mini-Mental State Exam (MMSE) score of 20 to 28 inclusive;
• \. Progressive cognitive complaints must be reported by participant or caregiver;
• \. 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;
• \. Fluency in the language of the tests used at the site;
• \. Participants must be interested in participating in clinical research.

You may not qualify if:

• \. 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;
• \. Participants who are currently enrolled in another clinical study.
• \. Participants who have serious or unstable medical conditions that would likely preclude their participation in an interventional research trial;
• \. Participants who have reported or have a known negative amyloid PET scan in the past 24 months;
• \. Participants with history of stroke within 6 months of prescreening;
• \. 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);
• \. 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;
• \. Participants with known or suspected alcohol or drug abuse or dependence within 2 years of prescreening;
• \. Participants with a reported suicidal attempt within 2 years of prescreening), or any unstable psychiatric symptoms (e.g., uncontrolled depression);
• \. 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;
• \. 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;
• \. Participants with known history of hepatitis C virus, hepatitis B virus, human immunodeficiency virus (HIV) or other immunodeficiencies;
• \. Participants that have previously been consented to this protocol;
• \. Participants with a hypersensitivity to mAb treatments, protein derived from a mAb, or immunoglobulin therapy;
• \. Participants with allergies to diphenhydramine, epinephrine, and methylprednisolone;

Sponsors & Collaborators

• Global Alzheimer's Platform Foundation: lead

Study Sites (19)

Pacific Research Network

San Diego, California, 92103, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Visionary Investigator's Network

Aventura, Florida, 33180, United States

Location

Charter Research

Lady Lake, Florida, 32159, United States

Location

JEM Research Institute

Lake Worth, Florida, 33462, United States

Location

ClinCloud, LLC

Maitland, Florida, 32751, United States

Location

K2 Medical Research

Maitland, Florida, 32751, United States

Location

Merritt Island Medical Research

Merritt Island, Florida, 32952, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

ClinCloud, LLC

Viera, Florida, 32940, United States

Location

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Charter Research

Winter Park, Florida, 32792, United States

Location

iResearch

Decatur, Georgia, 30030, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

IPS Research

Oklahoma City, Oklahoma, 73106, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Re:Cognition Health

Fairfax, Virginia, 22031, United States

Location

OCT Research

Kelowna, British Colombia, V1V 1Z9, Canada

Location

Related Publications (6)

• 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.

  PMID: 27668883 BACKGROUND

• 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.

  PMID: 2106207 BACKGROUND

• 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.

  PMID: 29653606 BACKGROUND

• 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.

  PMID: 24503555 BACKGROUND

• 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.

  PMID: 28752420 BACKGROUND

• 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.

  PMID: 18625866 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Aβ 42/40, Aβ 42, Aβ40, ApoE4, APS

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 6, 2022
• Study Start: June 13, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

US (18); CA (1)