NCT06618872

Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With Cognitive Impairment

Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dementia
• Alzheimer Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PET/CT with RO958 (experimental)	the participant will have 2 PET (one with an experimental radiotracer- Tau PET), one with a standard radiotracer (amyloid-PET)

Timeline

• Start date: 2024-12-03
• Primary completion: 2027-08-30
• Completion: 2027-08-30
• First posted: 2024-10-01
• Last updated: 2025-12-23

Locations

2 sites across 1 country: Switzerland