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

Официальное название

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

Обзор

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

Подробное описание

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

Вмешательства

• Диагностический тест 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)

Первичные конечные точки

• 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 [Срок оценки: 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). [Срок оценки: through study completion , an average of 2 years]

Вторичные конечные точки (3)

• Accuracy of clinical and biomarker-based diagnoses [Срок оценки: through study completion , an average of 2 years]
• Amyloid-PET and tau-PET predictivity of cognitive decline and dementia onset [Срок оценки: through study completion , an average of 2 years]
• Absence of adverse events [Срок оценки: through study completion , an average of 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Швейцария · 2 центра

• Geneva University Hospital — Geneva
• Centre Medical Universitaire Vaudois — Lausanne

Идентификаторы

NCT: NCT06618872 · 2023-02263

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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