HumRes65912
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SNCTP000006160
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BASEC2023-02263
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NCT06618872
Diagnostic difference between tau-PET with [18F]RO948 and amyloid-PET in individuals with cognitive impairment.
Summary description of the study
In this study, we will evaluate the deposits of toxic proteins using 2 radiotracers (injected molecules to visualize deposits by PET) RO948 for the Tau protein and Vizamyl for the Amyloid protein.
(BASEC)
Intervention under investigation
In the presence of cognitive disorders (language, reasoning, perception, decision-making, attention, memory, etc.), positron emission tomography (PET) allows for the evaluation of toxic protein deposits in the brain, particularly amyloid and tau protein, and helps to understand the role they play in neurodegeneration.
(BASEC)
Disease under investigation
Cognitive disorders
(BASEC)
Criteria for participation in trial
Age between 50 and 85 years Diagnosis of mild cognitive impairment MRI performed within the last 6 months Prescription of a diagnostic amyloid PET/CT. (BASEC)
Exclusion criteria
- Presence of psychiatric disorders, extensive white matter lesions, or other signs of vascular dementia. - Insufficient visual and auditory acuity to allow for neuropsychological testing. - Participation in previous clinical trials on Alzheimer's disease that may affect amyloid and/or tau brain burden. - Participation in other trials or studies not compatible with the [18F]RO948 imaging study. - Implants and ferromagnetic devices (including implants or devices held in place by sutures, granulation or tissue growth, fixation devices, or by other means) are not eligible for MRI. - Women of childbearing age must not be pregnant (negative urinary β-hCG level on the day of imaging) or breastfeeding at the time of screening. (BASEC)
Age between 50 and 85 years Diagnosis of mild cognitive impairment MRI performed within the last 6 months Prescription of a diagnostic amyloid PET/CT. (BASEC)
Exclusion criteria
- Presence of psychiatric disorders, extensive white matter lesions, or other signs of vascular dementia. - Insufficient visual and auditory acuity to allow for neuropsychological testing. - Participation in previous clinical trials on Alzheimer's disease that may affect amyloid and/or tau brain burden. - Participation in other trials or studies not compatible with the [18F]RO948 imaging study. - Implants and ferromagnetic devices (including implants or devices held in place by sutures, granulation or tissue growth, fixation devices, or by other means) are not eligible for MRI. - Women of childbearing age must not be pregnant (negative urinary β-hCG level on the day of imaging) or breastfeeding at the time of screening. (BASEC)
Trial sites
Geneva, Lausanne
(BASEC)
Switzerland (ICTRP)
Sponsor
Hôpitaux Universitaires de Genève
(BASEC)
Contact
Contact Person Switzerland
Pr Valentina Garibotto
+41 22 372 72 52
valentina.garibotto@clutterhug.chHUG
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
28.10.2024
(BASEC)
ICTRP Trial ID
NCT06618872 (ICTRP)
Official title (approved by ethics committee)
Incremental diagnostic value of tau-PET with [18F]RO948 vs amyloid-PET in patients with cognitive impairment (BASEC)
Academic title
Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With (ICTRP)
Public title
Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With Cognitive Impairment (ICTRP)
Disease under investigation
DementiaAlzheimer Disease (ICTRP)
Intervention under investigation
Diagnostic Test: PET/CT with RO958 (experimental) (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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 -hCG on the
day of imaging) or breast feeding at screening (ICTRP)
not available
Primary and secondary end points
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;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). (ICTRP)
Accuracy of clinical and biomarker-based diagnoses;Amyloid-PET and tau-PET predictivity of cognitive decline and dementia onset;Absence of adverse events (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Centre Hospitalier Universitaire Vaudois (ICTRP)
Additional contacts
Valentina Garibotto, MD, valentina.garibotto@hug.ch, +41223727252 (ICTRP)
Secondary trial IDs
2023-02263 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06618872 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available