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NCT Number: NCT06618872

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

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

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Frontotemporal Dementia Frontotemporal Lobar Degeneration Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pick Disease of the Brain Tauopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geneva University Hospital, Geneva, Canton of Geneva, Switzerland

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/CT with RO958 (experimental)

Diagnostic Test

the participant will have 2 PET (one with an experimental radiotracer- Tau PET), one with a standard radiotracer (amyloid-PET)

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

    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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. Absence of adverse events

    Time frame: through study completion , an average of 2 years

    Absence of adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Valentina Garibotto, MD

CONTACT

[email protected]

+41223727252

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois

Registry information

Official study title

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

Acronym: IDV of tau-PET

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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