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临床试验/NCT06621758
NCT06621758尚未招募不适用

Communication Regarding Preclinical Dementia Diagnostic and Diagnostic Disclosure Among Patients with MCI and SCD

Danish Dementia Research Centre0 个研究点目标入组 120 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Important issues in communication

研究概览

简要总结

The study investigate what information individuals with SCD or MCI and their co-participant would like to receive during pre-diagnostic counseling and diagnostic disclosure, and how this information should be conveyed.

详细描述

Improved diagnostic work-up and the introduction of disease-modifying treatment have led to a shift towards earlier diagnosis. However, there are a need for better understanding of how best to communicate about biomarker use, assessment, and results in individuals with subjective cognitive decline (SCD) and mild cognitive impairment (MCI).

Objective:

The overarching objective of this study is:

To understand what information individuals with SCD or MCI and their co-participant would like to receive during pre-diagnostic counseling and diagnostic disclosure, and how this information should be conveyed.

Methods: a prospective survey study Persons diagnosed with SCD or MCI and co-participants will be recruited consecutively from the memory clinic, Copenhagen University Hospital - Rigshospitalet (Denmark), Toulouse University Hospital, (France), University Medical Centre Ljubljana (Slovenia) and Universitair Ziekenhuis Brussel (Belgium)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with SCD or MCI
  • Lumbar puncture performed during the diagnostic process
  • Age at or below 80 years
  • MMSE at or above 24

排除标准

  • Diagnosis of current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis)
  • Current excessive alcohol intake or substance abuse
  • Inclusion criteria for the co-participant:
  • Attended the diagnostic disclosure visit together with the individual diagnosed with SCD or MCI

结局指标

主要结局

Important issues in communication

时间窗: From enrollment to the second questionnaire after 6 weeks

Rating of which issues are important for persons with SCD or MCI and their co-participant in the pre-diagnostic counseling and diagnostic disclosure communication.

次要结局

未报告次要终点

研究者

发起方
Danish Dementia Research Centre
申办方类型
Network
责任方
Principal Investigator
主要研究者

Kristian Steen Frederiksen, MD

MD, PhD, clinical lector

Danish Dementia Research Centre

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