ADDIA Proof-of-Performance Clinical Study (NCT03030586) | Clinical Trial Compass
CompletedNot Applicable
ADDIA Proof-of-Performance Clinical Study
Belgium, France, Italy821 participantsStarted 2016-09-01
Plain-language summary
The objective of the ADDIA clinical Proof-of-Performance study is to validate the performance of ADDIA' blood biomarkers for diagnosis of Alzheimer's disease (AD).
ADDIA clinical study is a multi-centre, non-interventional, prospective, proof-of-performance study with only one visit.
About 800 well-characterized subjects will be recruited into 3 groups in 2:1:1 ratio, namely patients with Alzheimer's disease (AD), patients with non-AD neurodegenerative disease (NAD) and 200 control subjects (healthy as compared to their age).
* 400 patients with Alzheimer's disease (AD): 200 patients with mild AD, 200 patients with moderate-to-severe AD,
* 200 patients with non-Alzheimer's neurodegenerative diseases (NAD),
* 200 controls (healthy as compared to their age).
Who can participate
Age range
40 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 groups:
* Female and male subjects aged 40 to 85 years.
* Dated and signed informed consent by the subject (or its legal representative if applicable in accordance with the local regulations).
* AD, NAD patients and control subjects will be age-matched and mean age similar in the three groups.
* Able to comply with all study procedures.
For AD group:
* Diagnosis of AD: typical and atypical AD.
* MMSE score (measured in the last 3 months): \< 21 for patients with moderate to severe AD. MMSE score \> 21 in subjects with mild AD with sporadic or a familial form of AD due to mutation in APP or PSEN1 or PSEN2 genes.
* FCSRT, MoCA tests (MoCA measured in the last 3 months).
* Neuroimaging compatible with a diagnosis of AD:
* At least quantitative volumetric structural MRI: volumes of hippocampus and cortical areas.
* Visual semi-quantitative MRI if practiced shall show medial temporal lobe atrophy (MTA) and parietal atrophy with visual rating (semi-quantitative) on the MTA-score (e.g. Scheltens' scores 0-4). MTA score must be ≥ 2 in patients aged 40-75 years and ≥ 3 in patients aged above 75 years. For patients younger than 60 years, and with familial form of AD, who may have normal MTA-scores, Koedam score (0-3) for Parietal Atrophy showing atrophy of the precuneus characteristic of AD may be used with a Koedam score from 1 to 3.
Other neuroimaging data (retrospectively available) including PET Amyloid scan and FDG PET are desired if practiced…
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.