The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease (BRIDGE-AD2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 550
- 试验地点
- 8
- 主要终点
- Time from baseline to final diagnosis
研究概览
简要总结
Cognitive disorders have a broad differential diagnosis, and a precise, timely diagnosis is essential for personalized treatment and care. Currently, dementia diagnoses are often not further specified according to the underlying pathology and are frequently delayed by several years. However, with the upcoming disease-modifying treatments (DMTs) for AD, an accurate, pathology-driven (i.e., etiological) diagnosis will become necessary.
Blood-based biomarkers (BBMs) are promising tools for detecting Alzheimer's disease (AD), with current research showing high concordance with cerebrospinal fluid (CSF) biomarkers and amyloid PET imaging. However, it remains unclear how physicians would value the availability of BBMs for AD in routine clinical practice. The investigators hypothesize that BBMs will benefit both patients and physicians in the diagnostic process within a memory clinic setting.
This study aims to investigate clinical impact and diagnostic utility of blood-based biomarkers for AD in the diagnostic process of a memory clinic. The main objectives are to investigate change in diagnosis, diagnostic certainty and patient management, due to BBM results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presents in memory clinic with cognitive complaints.
- •The physician is concerned about underlying AD as etiology of the complaints.
- •Adequate fluency in Dutch to understand informed consent procedure.
排除标准
- •Age under
- •Previous biomarker-confirmed diagnosis of AD.
- •Alcohol or drug abuse to such an extent that treatment would be advisable.
- •Patient is incapacitated, and is not able to judge consequences of participation.
结局指标
主要结局
Time from baseline to final diagnosis
时间窗: From enrolment to final diagnosis, assessed up to 100 months
The time from baseline visit to final diagnosis will be reported in days.
Change in diagnosis
时间窗: From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months
Comparison between the diagnosis (syndrome diagnosis and etiology) before and after BBM testing. Change in diagnosis will be reported as yes/no.
Change in physician's confidence in diagnosis
时间窗: From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months
Comparison between physician's confidence in diagnosis before and after BBM testing within the intervention group. Physician's confidence will be measured on a 7-point Likert scale, with 1 being very uncertain and 7 being very certain.
次要结局
- Difference between the intervention group and the control group in use and timing of ancillary tests(From enrolment to final diagnosis, assessed up to 100 months)
- Concordance of BBM results with the presence of AD pathology according to CSF or amyloid PET(From enrolment to final diagnosis, assessed up to 100 months)
- Difference between the intervention group and the control group in patient management: follow-up duration(From enrolment to final diagnosis, assessed up to 100 months)
- Difference between the intervention group and the control group in patient management: referral(From enrolment to final diagnosis, assessed up to 100 months)
- Difference between the intervention group and the control group in patient management: prescription of medication(From enrolment to final diagnosis, assessed up to 100 months)
研究者
Floor Duits
Dr.
Alzheimercentrum Amsterdam