MILD COGNITIVE IMPAIRMENT Clinical Trial
Official title:
Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment: a Two-part Clinical Study. PartA: Multisite MRI Acquisition, Protocol Harmonization. PartB: Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment: a Clinical Study
THE STUDY WILL BE A TWO-PART RESEARCH
PART A and PART A extended:
1. To implement a "common" MRI acquisition protocol in multiple centers across Europe
(Pharma-COG partners).
2. Apply the common MRI protocol on phantoms and human subjects to characterize, compare
and minimize test-retest variability across the MR sites of WP5 for all the
quantitative metrics that will be later assessed on patients.
PART B: By collecting clinical, biochemical, neuroimaging, neuropsychological and
neurophysiological data in Mild Cognitive Impairment patient, we aim to:
1. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints)
which is more sensitive than the changes observed in the loss of hippocampal volume
(primary endpoint) and correlate with the neuropsychological progression and conversion
(clinical secondary endpoints).
2. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints)
at baseline which is more predictive of the loss of hippocampal volume (primary
endpoint) and neuropsychological progression (clinical secondary endpoint) in MCI
patients.
3. To harmonize the biomarker MATRIX collection and qualify multiple centres across Europe
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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