The objective of the study is to investigate the clinical validity of tau-PET with \[18F\]RO948 vs. amyloid-PET in patients with Mild Cognitive Impairment (MCI) or mild dementia
Dementia is defined as cognitive impairment associated with loss of autonomy and is usually preceded by a prodromal phase - Mild Cognitive Impairment (MCI) - which represents a highly heterogeneous entity comprising different underlying etiologies, of which Alzheimer's disease (AD) is one of the most prevalent. Several AD biomarkers - including MRI, FDG-PET and CSF measures of amyloid and tau pathology - have been validated as diagnostic (allowing an early and differential diagnosis of AD) and prognostic (predicting progression from MCI to dementia due to AD) tools. In contrast and despite the increasing consensus on their clinical utility, usage of PET markers of amyloid and tau pathology is not yet standard clinical practice. Moreover, while the clinical utility of amyloid-PET has been exhaustively investigated, to date no study has prospectively assessed the clinical utility of tau-PET. Assessing the clinical utility of diagnostic tools is fundamental for clinical practice. This will be the first study assessing the clinical utility of \[18F\]RO948 tau-PET vs. standard of care amyloid-PET, providing unique information to define appropriate diagnostic algorithms
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
the participant will have 2 PET (one with an experimental radiotracer- Tau PET), one with a standard radiotracer (amyloid-PET)
Geneva University Hospital
Geneva, Canton of Geneva, Switzerland
RECRUITINGCentre Medical Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland
RECRUITINGDifference between tau-PET with [18F]RO948 and amyloid PET in the change of physician's diagnostic confidence (50-100% visual analogue scale) across time
Amyloid and tau PET scans will be classified as positive or negative for the presence of pathology using visual reading by an expert reader (amyloid-PET), as clinically established, and SUVR cut offs previously published for \[18F\]RO948 tau-PET (Leuzy, Smith et al. 2020) as well as a visual check
Time frame: through study completion , an average of 2 years
Difference between tau-PET with [18F]RO948 and amyloid PET in the changes in etiological diagnoses across time (i.e., from Alzheimer disease (AD) to non-AD, or from non-AD to AD).
The changes in etiological diagnosis across rounds will be assessed using the McNemar's test
Time frame: through study completion , an average of 2 years
Accuracy of clinical and biomarker-based diagnoses
the accuracy of clinical (routine workup only) and biomarker-based diagnoses (based on tau-PET with \[18F\]RO948 or amyloid-PET or both) using the 2-year follow-up biomarker based diagnosis as gold standard
Time frame: through study completion , an average of 2 years
Amyloid-PET and tau-PET predictivity of cognitive decline and dementia onset
The amyloid-PET and tau-PET predictivity of cognitive decline and dementia onset will be assessed using linear mixed models with cognition as dependent variable; results of amyloid-PET or tau-PET, time and their interaction as independent variables; and age, gender and education as covariates
Time frame: through study completion , an average of 2 years
Absence of adverse events
Absence of adverse events
Time frame: through study completion , an average of 2 years
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