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

Completed

Conditions studied: Alzheimer Disease, Mild Cognitive Impairment, Memory Loss, Memory Disorders, Memory Impairment

In brief

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.

Key facts

Study ID

NCT05364307

Run by

Global Alzheimer's Platform Foundation

People needed

1555

Starts

2022-06-13

Expected to finish

2025-01-31

Last updated by the study team

2025-02-05

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• 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…

• 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;
• 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;
• Participants who are direct employees or family members of direct employees of the participating investigators' sites;
• Participants who are direct employees of the Sponsor;
• Participants who, in the opinion of the Investigator, are unable to complete cognitive testing due to inadequate visual or auditory acuity.

Where it is running

• Pacific Research Network — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Visionary Investigator's Network — Aventura, Florida, United States
• Charter Research — Lady Lake, Florida, United States
• JEM Research Institute — Lake Worth, Florida, United States
• ClinCloud, LLC — Maitland, Florida, United States
• K2 Medical Research — Maitland, Florida, United States
• Merritt Island Medical Research — Merritt Island, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• ClinCloud, LLC — Viera, Florida, United States
• Premiere Research Institute at Palm Beach Neurology — West Palm Beach, Florida, United States
• Conquest Research — Winter Park, Florida, United States
• Charter Research — Winter Park, Florida, United States
• iResearch — Decatur, Georgia, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• IPS Research — Oklahoma City, Oklahoma, United States
• Clinical Trials of Texas — San Antonio, Texas, United States
• Re:Cognition Health — Fairfax, Virginia, United States
• OCT Research — Kelowna, British Colombia, Canada

Full record on ClinicalTrials.gov

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