Dementia risk estimation in persons at risk and the predictive turn in Alzheimer's disease-The PreTAD project: Study protocol with an ethical, clinical, linguistic, and legal approach.

IF 2.6 3区综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES

PLoS ONE Pub Date : 2025-07-16 eCollection Date: 2025-01-01 DOI:10.1371/journal.pone.0319868

Michelle Gerards, Annika Baumeister, Constanze Hübner, Federica Ribaldi, Yahveth Cantero-Fortiz, Julia Braun, Mercè Boada, Giovanni B Frisoni, Frank Jessen, Björn Schmitz-Luhn, Carolin Schwegler, Christiane Woopen, Ayda Rostamzadeh

{"title":"Dementia risk estimation in persons at risk and the predictive turn in Alzheimer's disease-The PreTAD project: Study protocol with an ethical, clinical, linguistic, and legal approach.","authors":"Michelle Gerards, Annika Baumeister, Constanze Hübner, Federica Ribaldi, Yahveth Cantero-Fortiz, Julia Braun, Mercè Boada, Giovanni B Frisoni, Frank Jessen, Björn Schmitz-Luhn, Carolin Schwegler, Christiane Woopen, Ayda Rostamzadeh","doi":"10.1371/journal.pone.0319868","DOIUrl":null,"url":null,"abstract":"Background: Despite progress in the field of Alzheimer's disease (AD) dementia risk estimation, little is known about its impact at the individual and societal levels.Objective: Introducing the explorative tri-national PreTAD project (The Predictive Turn in Alzheimer's Disease: Ethical, Clinical, Linguistic and Legal Aspects), which aims to (1) learn about attitudes, needs, and perspectives on AD dementia risk estimation of the general population and cognitively unimpaired individuals with and without contact to memory clinics, (2) identify anticipated impacts of AD dementia risk estimation and (3) discuss the implications of the paradigm shift in medicine at individual and societal levels from an ethical, linguistic and legal perspective.Methods: Different approaches are used: (1) an assessment of a population without experience with dementia, (2) an assessment in memory clinics, and (3) an online survey of the general population. Participants include cognitively healthy adults (n=2760), first-degree relatives of dementia patients (n=150), and participants with existing (n=150) and newly diagnosed (n=90) subjective cognitive decline (SCD) from Germany, Switzerland, and Spain.Results: As part of the PreTAD project, new questionnaires are developed that (1) collect attitudes, needs, and perspectives on AD dementia risk estimation and (2) assess anticipated impacts of dementia risk estimation using hypothetical blood-based biomarker dementia risk scenarios.Conclusion: The PreTAD study combines an interdisciplinary approach to develop a framework for predictive medicine in the preclinical stages of AD and supports improving communication of biomarker-based dementia risk estimation in clinical practice. The study was registered in the German Clinical Trials Register (DRKS00029035 on 03/08/2023).Trial registration: German clinical trials register (Deutsches Register Klinischer Studien, DRKS): http://www.drks.de/DRKS00029035, DRKS registration number: DRKS00029035, date of registration: 08.03.2023. Protocol version 3.0, date 01.06.2024.","PeriodicalId":20189,"journal":{"name":"PLoS ONE","volume":"20 7","pages":"e0319868"},"PeriodicalIF":2.6000,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12266435/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"PLoS ONE","FirstCategoryId":"103","ListUrlMain":"https://doi.org/10.1371/journal.pone.0319868","RegionNum":3,"RegionCategory":"综合性期刊","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"MULTIDISCIPLINARY SCIENCES","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Despite progress in the field of Alzheimer's disease (AD) dementia risk estimation, little is known about its impact at the individual and societal levels.

Objective: Introducing the explorative tri-national PreTAD project (The Predictive Turn in Alzheimer's Disease: Ethical, Clinical, Linguistic and Legal Aspects), which aims to (1) learn about attitudes, needs, and perspectives on AD dementia risk estimation of the general population and cognitively unimpaired individuals with and without contact to memory clinics, (2) identify anticipated impacts of AD dementia risk estimation and (3) discuss the implications of the paradigm shift in medicine at individual and societal levels from an ethical, linguistic and legal perspective.

Methods: Different approaches are used: (1) an assessment of a population without experience with dementia, (2) an assessment in memory clinics, and (3) an online survey of the general population. Participants include cognitively healthy adults (n=2760), first-degree relatives of dementia patients (n=150), and participants with existing (n=150) and newly diagnosed (n=90) subjective cognitive decline (SCD) from Germany, Switzerland, and Spain.

Results: As part of the PreTAD project, new questionnaires are developed that (1) collect attitudes, needs, and perspectives on AD dementia risk estimation and (2) assess anticipated impacts of dementia risk estimation using hypothetical blood-based biomarker dementia risk scenarios.

Conclusion: The PreTAD study combines an interdisciplinary approach to develop a framework for predictive medicine in the preclinical stages of AD and supports improving communication of biomarker-based dementia risk estimation in clinical practice. The study was registered in the German Clinical Trials Register (DRKS00029035 on 03/08/2023).

Trial registration: German clinical trials register (Deutsches Register Klinischer Studien, DRKS): http://www.drks.de/DRKS00029035, DRKS registration number: DRKS00029035, date of registration: 08.03.2023. Protocol version 3.0, date 01.06.2024.

Abstract Image

查看原文本刊更多论文

高危人群的痴呆风险评估和阿尔茨海默病的预测转向- PreTAD项目：具有伦理、临床、语言和法律方法的研究方案。

背景：尽管在阿尔茨海默病（AD）痴呆风险评估领域取得了进展，但对其在个人和社会层面的影响知之甚少。目的：介绍探索性的三国PreTAD项目(阿尔茨海默病的预测转折：伦理、临床、语言和法律方面)，旨在(1)了解一般人群和有或没有接触记忆诊所的认知障碍个体对阿尔茨海默病风险评估的态度、需求和观点；(2)确定阿尔茨海默病风险评估的预期影响；(3)从伦理、语言和法律的角度讨论个人和社会层面医学范式转变的影响。方法：使用了不同的方法：(1)对没有痴呆症经历的人群进行评估，(2)在记忆诊所进行评估，(3)对一般人群进行在线调查。参与者包括认知健康的成年人（n=2760），痴呆症患者的一级亲属（n=150），以及来自德国、瑞士和西班牙的已有（n=150）和新诊断（n=90）主观认知衰退（SCD）的参与者。结果：作为PreTAD项目的一部分，开发了新的问卷，(1)收集对阿尔茨海默病痴呆风险估计的态度、需求和观点；(2)使用假设的基于血液的生物标志物痴呆风险情景评估痴呆风险估计的预期影响。结论：PreTAD研究结合了跨学科的方法，为阿尔茨海默病临床前阶段的预测医学开发了一个框架，并支持在临床实践中改善基于生物标志物的痴呆风险评估的交流。该研究已于2023年3月8日在德国临床试验注册（DRKS00029035）注册。试验注册：德国临床试验注册（Deutsches register Klinischer studen， DRKS）： http://www.drks.de/DRKS00029035， DRKS注册号：DRKS00029035，注册日期：08.03.2023。协议版本3.0，日期为2024年1月6日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

PLoS ONE 生物-生物学

CiteScore

6.20

自引率

5.40%

发文量

14242

审稿时长

3.7 months

期刊介绍： PLOS ONE is an international, peer-reviewed, open-access, online publication. PLOS ONE welcomes reports on primary research from any scientific discipline. It provides: * Open-access—freely accessible online, authors retain copyright * Fast publication times * Peer review by expert, practicing researchers * Post-publication tools to indicate quality and impact * Community-based dialogue on articles * Worldwide media coverage