Identification of Patients With a High Probability of Meeting Eligibility Criteria for an Alzheim… (NCT05364307) | Clinical Trial Compass
CompletedNot Applicable
Identification of Patients With a High Probability of Meeting Eligibility Criteria for an Alzheimer's Disease Clinical Trial (APHELEIA)
United States, Canada1,555 participantsStarted 2022-06-13
Plain-language 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.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 uncontr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine number of patients eligible for therapeutic Alzheimer's Disease clinical trial
Timeframe: Throughout study completion, an average of 45 days