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.
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Cognitive disorders
(BASEC)
Kriterien zur Teilnahme
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)
Ausschlusskriterien
- 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)
Ausschlusskriterien
- 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)
Studienstandort
Genf, Lausanne
(BASEC)
Switzerland (ICTRP)
Sponsor
Hôpitaux Universitaires de Genève
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Pr Valentina Garibotto
+41 22 372 72 52
valentina.garibotto@clutterhug.chHUG
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
28.10.2024
(BASEC)
ICTRP Studien-ID
NCT06618872 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Incremental diagnostic value of tau-PET with [18F]RO948 vs amyloid-PET in patients with cognitive impairment (BASEC)
Wissenschaftlicher Titel
Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With (ICTRP)
Öffentlicher Titel
Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With Cognitive Impairment (ICTRP)
Untersuchte Krankheit(en)
DementiaAlzheimer Disease (ICTRP)
Untersuchte Intervention
Diagnostic Test: PET/CT with RO958 (experimental) (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Centre Hospitalier Universitaire Vaudois (ICTRP)
Weitere Kontakte
Valentina Garibotto, MD, valentina.garibotto@hug.ch, +41223727252 (ICTRP)
Sekundäre IDs
2023-02263 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06618872 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar