Incremental Diagnostic Value of Tau-PET with [18F]RO948 Vs Amyloid-PET in Patients with Cognitive Impairment
- Conditions
- DementiaAlzheimer Disease
- Interventions
- Diagnostic Test: PET/CT with RO958 (experimental)
- Registration Number
- NCT06618872
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
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
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- prescription of a diagnostic amyloid PET
- Willing and able to comply with the requirements of the study, as judged by the investigator.
- 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.
- Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning.
- Women of childbearing potential must not be pregnant (negative urine β-hCG on the day of imaging) or breast feeding at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Amyloid-PET and then Tau-PET PET/CT with RO958 (experimental) The participant will have the Amyloid-PET (standard of care) and then Tau-PET (experimental) Tau-PET and then Amyloid-PET PET/CT with RO958 (experimental) The participant will have the Tau-PET (experimental) and then the Amyloid-PET (standard of care)
- Primary Outcome Measures
Name Time Method 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 through study completion , an average of 2 years 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
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). through study completion , an average of 2 years The changes in etiological diagnosis across rounds will be assessed using the McNemar's test
- Secondary Outcome Measures
Name Time Method Accuracy of clinical and biomarker-based diagnoses through study completion , an average of 2 years 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
Amyloid-PET and tau-PET predictivity of cognitive decline and dementia onset through study completion , an average of 2 years 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
Absence of adverse events through study completion , an average of 2 years Absence of adverse events
Trial Locations
- Locations (2)
Geneva University Hospital
🇨🇭Geneva, GE, Switzerland
Centre Medical Universitaire Vaudois
🇨🇭Lausanne, VD, Switzerland