Clinical trial NCT06618872: Incremental Diagnostic Value of Tau-PET with [18F]RO948 Vs Amyloid-PET in Patients with Cognitive Impairment
Official title: Incremental Diagnostic Value of Tau-PET with [18F]RO948 Vs Amyloid-PET in Patients with
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Alzheimer Disease
Keywords: Alzheimer
PET
Amyloid
Tau
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2024-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will have first a Tau-PET (experimental) and then an amyloid PET (standard of care) or the opposite
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: through study completion , an average of 2 years
measure: 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).
timeFrame: through study completion , an average of 2 years
Secondary outcomes:
measure: Accuracy of clinical and biomarker-based diagnoses
timeFrame: through study completion , an average of 2 years
measure: Amyloid-PET and tau-PET predictivity of cognitive decline and dementia onset
timeFrame: through study completion , an average of 2 years
measure: Absence of adverse events
timeFrame: through study completion , an average of 2 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
state: GE
city: Lausanne
country: Switzerland
facility: Centre Medical Universitaire Vaudois
state: VD
Study officials:
References: