Mild Cognitive Impairment Clinical Trial
Official title:
Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease
Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a
major matter of concern. There is now an important body of literature stating that early
isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing
AD. Several biomarkers are now available : specific and sensitive neuropsychological
assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI,
cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain
glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging
using labelled compounds specifically binding to APs has been suggested to improve the
diagnostic reliability and to potentially help in shortening the delay until formal clinical
diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to
15 minutes acquisition 50 to 60 minutes post injection.
Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD,
MCI patients and Healthy Controls.
Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will
have convert toward dementia versus those who will not, at two year follow-up period, to
compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG
hypometabolism, ApoE genotype.
Method: Prospective multicentric study. 65 patients expected to enter the study.
Primary outcome measure: Standard Uptake Volume ratios.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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