The clinical value of tau PET in the memory clinic (TAP-TAU)
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 5
- 主要终点
- Pre- vs. post-tau PET change in diagnosis (diagnostic categories: AD, non-AD with specification of suspected underlying pathology, mixed AD/non-AD pathology) and comparison with a control group after a year
研究概览
简要总结
To assess the value of tau PET as a diagnostic tool in clinical practice in order to improve diagnostic accuracy, patient management and patient wellbeing.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients 50 years or older
- •Prodromal (i.e. MCI) stage, in which individuals have subjective and/or objective cognitive impairment and a CDR score of 0.5 or mild dementia stage, in which individuals have a CDR score of 1
- •Completed routine work-up including at least basic cognitive screening tests and MRI scanning with a 3DT1 sequence
- •After routine dementia screening, there is substantial diagnostic uncertainty (<85%) due to i) suspicion of mixed pathology, ii) presence of an atypical clinical presentation, and/or iii) conflicting/inconclusive information from other diagnostic tests like MRI or CSF. AD is in the differential diagnosis.
- •Subjects must, in the opinion of the attending neurologist be able to tolerate study procedures (only for the tau PET participants) and be competent to make a well-informed decision to participate in this study
排除标准
- •Cognitively normal (defined as no objective cognitive deficits at neuropsychological testing and a Clinical Dementia rating scale (CDR) score of 0) or advanced dementia stage (defined as CDR > 1).
- •Has evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with the clinical presentation and/or interpretation of PET scan
- •Is a woman of childbearing potential who is not surgically sterile, not refraining from sexual activity or not using reliable methods for contraception. Women of childbearing potential must confirm not to be pregnant or breast feeding at screening; (only for tau PET participants)
- •Has a relevant history of severe drug allergy or hypersensitivity. Relevant severe drug allergies should be determined by the locally appointed coordinating researcher (only for tau PET participants)
- •Has ever been treated with an anti-amyloid drug or tau agent (only for tau PET participants)
- •History of any clinically significant cardiovascular, endocrinology, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic (with the exception of AD), psychiatric, renal or other major disease, as determined by the principal investigator
- •Has been injected with a previously administered radiopharmaceutical within 6 terminal half-lives or when total yearly radiation exposure for research exceeds 11.3 mSv for females and 15.3 mSv for males. (only for tau PET participants)
- •Is a member of the study team, an employee of the department of Radiology and Nuclear medicine or the department of Neurology in any of the sites or is related to an employee of the department of Radiology and Nuclear medicine or the department of Neurology in any of the sites.
结局指标
主要结局
Pre- vs. post-tau PET change in diagnosis (diagnostic categories: AD, non-AD with specification of suspected underlying pathology, mixed AD/non-AD pathology) and comparison with a control group after a year
Pre- vs. post-tau PET change in diagnosis (diagnostic categories: AD, non-AD with specification of suspected underlying pathology, mixed AD/non-AD pathology) and comparison with a control group after a year
Pre- vs. post-tau PET change in confidence of the clinician in the etiological diagnosis (continuous scale ranging from 0-100%, baseline <85% required) and comparison with a control group after a year.
Pre- vs. post-tau PET change in confidence of the clinician in the etiological diagnosis (continuous scale ranging from 0-100%, baseline <85% required) and comparison with a control group after a year.
Pre- vs. post-tau PET change in patient management (increase or reduction in ancillary investigations, initiation or withdrawal of medication, initiation or withdrawal of care; we will also assess whether it would influence hypothetical prescription of disease modifying treatment of AD) and comparison with a control group after a year.
Pre- vs. post-tau PET change in patient management (increase or reduction in ancillary investigations, initiation or withdrawal of medication, initiation or withdrawal of care; we will also assess whether it would influence hypothetical prescription of disease modifying treatment of AD) and comparison with a control group after a year.
Pre- vs. post-tau PET change in patient wellbeing (measures of anxiety and uncertainty) and behavioural intentions and post-tau PET perceptions, experiences and understanding of tau PET.
Pre- vs. post-tau PET change in patient wellbeing (measures of anxiety and uncertainty) and behavioural intentions and post-tau PET perceptions, experiences and understanding of tau PET.
次要结局
- Performance of tau PET compared to novel blood-based biomarkers and artificial intelligence (AI) based classifiers.
研究者
Marie Vermeiren
Scientific
Amsterdam UMC