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

December 16, 2025 updated by: Valentina Garibotto, University Hospital, Geneva

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
    • Canton of Geneva
      • Geneva, Canton of Geneva, Switzerland, 1205
        • Recruiting
        • Geneva University Hospital
        • Sub-Investigator:
          • Giovanni Frisoni, Pr
        • Contact:
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1211
        • Recruiting
        • Centre Medical Universitaire Vaudois
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amyloid-PET and then Tau-PET
The participant will have the Amyloid-PET (standard of care) and then Tau-PET (experimental)
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)
Experimental: Tau-PET and then Amyloid-PET
The participant will have the Tau-PET (experimental) and then the Amyloid-PET (standard of care)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
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).
Time Frame: through study completion , an average of 2 years
The changes in etiological diagnosis across rounds will be assessed using the McNemar's test
through study completion , an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of clinical and biomarker-based diagnoses
Time Frame: 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
through study completion , an average of 2 years
Amyloid-PET and tau-PET predictivity of cognitive decline and dementia onset
Time Frame: 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
through study completion , an average of 2 years
Absence of adverse events
Time Frame: through study completion , an average of 2 years
Absence of adverse events
through study completion , an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2024

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-02263

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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