Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease (NCT07294586) | Clinical Trial Compass
CompletedNot Applicable
Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease
France200 participantsStarted 2019-10-28
Plain-language summary
This is a 24-month, monocentric, exploratory and observational clinical study aimed at developing and validating a blood-based diagnostic test for Alzheimer's disease (AD). The test is based on two complementary biomarkers: conformational changes in Protein Kinase C (PKC) and aggregation of β-amyloid peptide on red blood cell membranes. The study will also establish a biobank of serum, plasma, urine, and RNA samples for future biomarker research.
Who can participate
Age range
50 Years – 85 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:
For All Participants (HV and AD groups):
* Age between 50 and 85 years
* Ability to understand and sign informed consent
* Availability for the full duration of the study (24 months)
* Fasting capability for morning sample collection (between 8:30-12:00)
* Willingness to provide blood and urine samples for biomarker analysis and biobank storage
Additional Criteria for Healthy Volunteers (HV):
* No history or current diagnosis of neurodegenerative disease
* Normal cognitive function confirmed by neuropsychological testing (e.g., MMSE score within normal range)
* No significant abnormalities on brain imaging (CT or MRI if performed)
* No use of medications affecting cognitive function
Additional Criteria for Alzheimer's Disease Patients (AD):
* Clinical diagnosis of probable Alzheimer's disease based on standardized criteria
* Cognitive impairment confirmed by neuropsychological testing (e.g., MMSE score below threshold)
* Supporting evidence from brain imaging (CT or MRI) and/or cerebrospinal fluid biomarkers (if available)
* Stable medical condition allowing participation in study procedures
Exclusion Criteria:
For All Participants:
* History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder)
* Significant neurological conditions other than Alzheimer's disease (e.g., Parkinson's disease, stroke)
* Active malignancy or history of cancer within the past 5 years (except localized skin cancer)
* Severe renal, hepatic, or cardiovasc…
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
Quantification of Blood Biomarkers in Alzheimer's Disease and Healthy Subjects