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)

Global Alzheimer's Platform Foundation17 sites in 2 countries1,555 target enrollmentJune 13, 2022

ConditionsAlzheimer Disease Mild Cognitive Impairment Memory Loss Memory Disorders Memory Impairment

Overview

Phase: N/A
Intervention: Not specified
Conditions: Alzheimer Disease
Sponsor: Global Alzheimer's Platform Foundation
Enrollment: 1555
Locations: 17
Primary Endpoint: Determine number of patients eligible for therapeutic Alzheimer's Disease clinical trial
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 13, 2022

End Date

January 31, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Global Alzheimer's Platform Foundation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;

Outcomes

Primary Outcomes

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

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

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