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.
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'investigation
Cognitive disorders
(BASEC)
Critères de participation
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)
Critères d'exclusion
- 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)
Critères d'exclusion
- 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)
Lieu de l’étude
Genève, Lausanne
(BASEC)
Switzerland (ICTRP)
Sponsor
Hôpitaux Universitaires de Genève
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Pr Valentina Garibotto
+41 22 372 72 52
valentina.garibotto@clutterhug.chHUG
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Genève
(BASEC)
Date d'approbation du comité d'éthique
28.10.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06618872 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Incremental diagnostic value of tau-PET with [18F]RO948 vs amyloid-PET in patients with cognitive impairment (BASEC)
Titre académique
Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With (ICTRP)
Titre public
Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With Cognitive Impairment (ICTRP)
Maladie en cours d'investigation
DementiaAlzheimer Disease (ICTRP)
Intervention étudiée
Diagnostic Test: PET/CT with RO958 (experimental) (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Centre Hospitalier Universitaire Vaudois (ICTRP)
Contacts supplémentaires
Valentina Garibotto, MD, valentina.garibotto@hug.ch, +41223727252 (ICTRP)
ID secondaires
2023-02263 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT06618872 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible