Incremental Diagnostic Value of Tau-PET With [18F]RO948 vs Amyloid-PET in Patients With
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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
时间窗: 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).
时间窗: through study completion , an average of 2 years
The changes in etiological diagnosis across rounds will be assessed using the McNemar's test
次要结局
- Accuracy of clinical and biomarker-based diagnoses(through study completion , an average of 2 years)
- Amyloid-PET and tau-PET predictivity of cognitive decline and dementia onset(through study completion , an average of 2 years)
- Absence of adverse events(through study completion , an average of 2 years)
研究者
Valentina Garibotto
Head of Nuclear Medecine and molecular imaging
University Hospital, Geneva