DementiaIDV of tau-PETNCT06618872
Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With Cognitive Impairment
A study testing PET/CT with RO958 (experimental) in people with Dementia and Alzheimer Disease, run by University Hospital, Geneva at 2 sites in Switzerland.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- PET/CT with RO958 (experimental)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 3 Dec 2024to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Geneva University Hospital
Geneva, Canton of Geneva, 1205
Valentina Garibotto, Pr, +41 79 55 34 459, valentina.garibotto@hug.ch
Giovanni Frisoni, Pr
- Recruiting
Centre Medical Universitaire Vaudois
Lausanne, Canton of Vaud, 1211
Gilles Allali, MD, +41 21 314 5151, gilles.allali@chuv.ch
About this study
Official title: 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
Read the 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
- Being tested
- PET/CT with RO958 (experimental)
- Keywords
- Alzheimer, PET, Amyloid, Tau
- Medical subject headings
- Dementia, Alzheimer Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Amyloid-PET and then Tau-PET | Experimental | The participant will have the Amyloid-PET (standard of care) and then Tau-PET (experimental) Receives: 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) Receives: Diagnostic Test: PET/CT with RO958 (experimental) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through study completion , an average of 2 years
Secondary outcomes (3)
Accuracy of clinical and biomarker-based diagnoses
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
Measured: through study completion , an average of 2 years
Amyloid-PET and tau-PET predictivity of cognitive decline and dementia onset
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
Measured: through study completion , an average of 2 years
Absence of adverse events
Absence of adverse events
Measured: through study completion , an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start3 Dec 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will have first a Tau-PET (experimental) and then an amyloid PET (standard of care) or the opposite
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, Valentina Garibotto, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618872
- Sponsor's protocol ID
- 2023-02263
- Other IDs
- 2023
- Acronym
- IDV of tau-PET
- Status last verified
- Dec 2025
- First submitted
- 27 Sep 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With
- ClinicalTrials.gov ID
- NCT06618872
- Acronym / sponsor ID
- IDV of tau-PET / 2023-02263
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- Alzheimer, PET, Amyloid, Tau
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will have first a Tau-PET (experimental) and then an amyloid PET (standard of care) or the opposite
| Arm | Type | Receives |
|---|---|---|
| Amyloid-PET and then Tau-PET | Experimental | Diagnostic Test: PET/CT with RO958 (experimental)The participant will have the Amyloid-PET (standard of care) and then Tau-PET (experimental) |
| Tau-PET and then Amyloid-PET | Experimental | Diagnostic Test: PET/CT with RO958 (experimental)The participant will have the Tau-PET (experimental) and then the Amyloid-PET (standard of care) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Diagnostic test | Amyloid-PET and then Tau-PET, Tau-PET and then Amyloid-PET |
Primary outcome
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
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
3 secondary outcomes
Accuracy of clinical and biomarker-based diagnoses
Time frame: 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
Absence of adverse events
Time frame: through study completion , an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT with RO958 (experimental) in people with Dementia and Alzheimer Disease, run by University Hospital, Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Garibotto, MD (+41223727252, valentina.garibotto@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: through study completion , an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.