ADDIA Proof-of-Performance Clinical Study (NCT03030586) | Clinical Trial Compass
CompletedNot Applicable
ADDIA Proof-of-Performance Clinical Study
Belgium, France821 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 range40 Years – 85 Years
SexALL
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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…