Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorUniversity Hospital, Geneva
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written Inform Consent to participating.
50 to 85 years of age
a diagnosis of Mild Cognitive Impairment (MCI=at least one pathological neuropsychological test but no functional impairment based on the Amsterdam IADL score) or mild dementia (both cognitive and functional impairments)
availability of MRI within 6 months before screening
Disqualifiers
The presence of psychiatric disorders, extensive white matter lesions or other stigmata of vascular dementia.
Visual and auditory acuity inadequate for neuropsychological testing.
Enrolment in previous clinical trials for AD potentially affecting amyloid and/or tau brain load
Enrolment in other trials or studies not compatible with [18F]RO948 Imaging study.
Trial design
Design model
Crossover
Treatments tested in this trial
PET/CT with RO958 (experimental)
Diagnostic testthe participant will have 2 PET (one with an experimental radiotracer- Tau PET), one with a standard radiotracer (amyloid-PET)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Amyloid-PET and then Tau-PETExperimental treatment 1 intervention
Group B: Tau-PET and then Amyloid-PETExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference 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 years2
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 yearsSecondary outcomes
1
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 years2
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 years3
Absence of adverse events
Absence of adverse events
Time frame
through study completion , an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Geneva
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Collaborator
Source ClinicalTrials.gov