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

NCT06618872 | Recruiting

• 1 other identifier: 2023-02263
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Conditions

Dementia; Alzheimer Disease

Keywords

Alzheimer; PET; Amyloid; Tau

Outcome Measures

Primary Outcomes (2)

• 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

  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).

  The changes in etiological diagnosis across rounds will be assessed using the McNemar's test

  through study completion , an average of 2 years

Secondary Outcomes (3)

• Accuracy of clinical and biomarker-based diagnoses

  through study completion , an average of 2 years

• Amyloid-PET and tau-PET predictivity of cognitive decline and dementia onset

  through study completion , an average of 2 years

• Absence of adverse events

  through study completion , an average of 2 years

Study Arms (2)

Amyloid-PET and then Tau-PET

EXPERIMENTAL

The participant will have the Amyloid-PET (standard of care) and then Tau-PET (experimental)

Diagnostic Test: PET/CT with RO958 (experimental)

Tau-PET and then Amyloid-PET

EXPERIMENTAL

The participant will have the Tau-PET (experimental) and then the Amyloid-PET (standard of care)

Diagnostic Test: PET/CT with RO958 (experimental)

Interventions

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)

Amyloid-PET and then Tau-PET; Tau-PET and then Amyloid-PET

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written Inform Consent to participating.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Centre Hospitalier Universitaire Vaudois: collaborator

Study Sites (2)

Geneva University Hospital

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

Centre Medical Universitaire Vaudois

Lausanne, Canton of Vaud, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Pick Disease of the Brain

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Frontotemporal Dementia; Frontotemporal Lobar Degeneration

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Central Study Contacts

Valentina Garibotto, MD

CONTACT

+41223727252; valentina.garibotto@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nuclear Medecine and molecular imaging

Model Details: Participants will have first a Tau-PET (experimental) and then an amyloid PET (standard of care) or the opposite

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CH (2)