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临床试验/NCT07466394
NCT07466394招募中不适用

German: COGSCREEN II: Früherkennung Kognitiver Störungen Durch Screeningverfahren Von Haus- Und Fachärzten Bei Senioren in Deutschland English: COGSCREEN II: Early Detection of Cognitive Impairment Through Screening Procedures by General Practitioners and Specialists in Older Adults in Germany (DAC AccDx Munich Site)

Robert Perneczky1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年6月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Percentage of Participants With Alzheimer's Disease Diagnosis Supported by Blood Biomarker Evidence

研究概览

简要总结

While knowledge about dementia and its causes is increasing rapidly, healthcare systems remain ill-equipped to detect cognitive decline in the early stages of neurodegenerative diseases such as Alzheimer's disease (AD). However, improving the early identification of AD in the population is a prerequisite for dementia prevention and providing future disease-modifying treatments for individuals most likely to benefit. Subjective cognitive deficits (SCD) and mild cognitive impairment (MCI) may indicate prodromal AD, even in the absence of functional impairment; in conjunction with an AD-typical biomarker profile (such as abnormal protein markers in the cerebrospinal fluid, CSF), the risk of further cognitive decline increases significantly. Offering cognitive screening to individuals with SCD or MCI may therefore open a window of opportunity for early interventions.

Currently, there is no system in place for targeted, standardized identification of cases with minimal cognitive decline in Germany or worldwide, hindering efforts to detect neurodegenerative and other causes of cognitive impairment in large segments of the population. The lack of a robust approach for detecting early changes with acceptable accuracy outside of specialist clinics results in disappointingly low diagnostic rates. This is despite evidence showing that structured case finding programs can significantly improve the early detection of cognitive decline.

This project will build on an existing network of general practitioners (GPs) and specialists in private practice (neurologists, psychiatrist and geriatricians). The investigator's efforts will aim to strengthen and expand this network, resulting in a larger pool of doctors in the community who have specialized knowledge and a strong commitment to the care of people with dementia. Over the course of the project, the investigators will introduce participating physicians to proprietary digital cognitive tests and blood-based biomarkers (provided by Roche). Building on the success of the ongoing COGSCREEN project, which deploys a community-based recruitment strategy (project number 22-0786), this initiative will equip the Munich healthcare system with the necessary tools to effectively identify individuals most likely to benefit from upcoming disease-modifying treatments for AD. This will serve as a template for the implementation of a precision medicine approach to early diagnosis of AD in Germany and beyond.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female ≥ 60 years of age at the time of consent
  • Able to understand and voluntarily sign an informed consent according to the judgment of the practice team

排除标准

  • Subjects who are unable to hear or see well enough to complete the assessments
  • Prior diagnosis of dementia (with or without evidence of pathology) as documented in the medical record and/or diagnosed by a physician

研究组 & 干预措施

Blood-Based Biomarker Testing

Experimental

干预措施: Early Detection (Behavioral)

No Blood-bases Biomarker Testing

No Intervention

结局指标

主要结局

Percentage of Participants With Alzheimer's Disease Diagnosis Supported by Blood Biomarker Evidence

时间窗: through study completion, an average of 2 year

Proportion of participants diagnosed with Alzheimer's disease whose diagnosis is supported by pathological blood-based biomarker results according to predefined laboratory cut-off values. The outcome will be reported as the percentage of total Alzheimer's disease diagnoses that include biomarker confirmation.

次要结局

  • Participant acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire(Through study completion, an average of 2 year)
  • Changes in Clinical Management Following Implementation of the Screening Model(through study completion, an average of 2 year)
  • (Number of) clinician-reported deviations from the standard diagnostic workflow after implementation of Blood Biomarker testing(through study completion, an average of 2 year)
  • Mean direct diagnostic costs per participant during the diagnostic workup(through study completion, an average of 2 year)
  • Proportion of correctly classified cases for detection of early Alzheimer's disease using screening modalities(through study completion, an average of 2 year)
  • Physician acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire(through study completion, an average of 2 year)
  • Diagnostic Performance and User Acceptance of the BrainChex Digital Cognitive Test Battery(through study completion, an average of 2 year)

研究者

发起方
Robert Perneczky
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Robert Perneczky

Prof. Dr. Robert Perneczky

Ludwig-Maximilians - University of Munich

研究点 (1)

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