Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline - DECISION
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Development and Validation of a Consent Capacity Assessment Tool in Neurocognitive Disorders
研究概览
简要总结
DECISION Study - Summary Title: Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline
The DECISION study aims to develop and validate a simplified yet robust tool for assessing the capacity to give informed consent in patients with Alzheimer's disease and related dementias. Existing tools like the MacCAT-T are too complex for routine use, so this project focuses on creating a user-friendly, valid alternative that addresses language, attention, insight, judgment, and decision-making.
The study uses a multi-phase approach including:
- Development and validation of a new consent capacity test battery
- Correlation of cognitive decline with brain changes and biomarkers (MRI, OCT, plasma markers)
- Ethical, legal, and co-design perspectives to ensure practical and responsible application
The target group includes 100-150 participants from earlier dementia studies. The ultimate goal is to establish a clinically usable, legally sound instrument for assessing consent capacity in individuals with cognitive impairments.
详细描述
Title: DECISION Study: Ethical Consent and Cognitive Decline Assessment in Dementia Detailed Study Description (Design-Focused)
- Background and Rationale The ability to provide informed consent is central to ethical research participation and clinical decision-making. However, in individuals with neurocognitive disorders, such as Alzheimer's disease (AD), frontotemporal dementia (FTD), or vascular dementia, this capacity is often compromised. The fluctuating nature of cognitive symptoms, especially in early and mixed dementia presentations, complicates standardized assessments. Currently used instruments, such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), are comprehensive but not suited for rapid clinical decision-making or large-scale implementation.
Emerging therapeutic interventions and increased demand for early diagnosis necessitate scalable, valid instruments to assess capacity. DECISION seeks to close this gap by developing a tool grounded in neuropsychological theory, clinical practicality, and ethical and legal acceptability. 2. Objectives
Primary Objective:
• Develop a standardized, brief, and reusable tool to assess capacity to consent in individuals with neurocognitive disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 50 years
- •Diagnosis or suspected diagnosis of a neurocognitive disorder (e.g., Alzheimer's disease, frontotemporal dementia, vascular dementia, mixed forms) based on ICD-10 criteria
- •Ability to provide informed consent, or availability of a legally authorized representative
- •Sufficient language proficiency to complete cognitive assessments
- •Availability of a trusted informant (e.g., caregiver or relative) for external rating instruments
- •Willingness to participate in neuropsychological testing, blood sampling, and optional imaging
排除标准
- •Severe sensory impairments (e.g., blindness, deafness) that prevent completion of assessments
- •Acute psychiatric conditions (e.g., psychosis, severe depression) that interfere with study procedures
- •History of major neurological disorders unrelated to dementia (e.g., traumatic brain injury, stroke with severe residual deficits)
- •Uncontrolled systemic illness or unstable medical condition
- •Refusal or inability to undergo necessary procedures (e.g., blood draw, optic coherence tomography, MRI)
- •Participation in another interventional study that could interfere with the outcomes of this study
研究组 & 干预措施
Individuals with AD spectrum for consent capacity and biomarker validation study
This cohort includes 100-150 individuals aged 50 and above with varying degrees of neurocognitive impairment, including Alzheimer's disease, frontotemporal dementia, vascular dementia, and mixed forms. Participants are recruited from prior studies (e.g., AmyClear, ActiGlia) with existing diagnostic data such as CSF biomarkers and PET imaging. The primary aim is to assess and validate a novel, scalable instrument for evaluating consent capacity. Interventions are non-invasive and include cognitive testing, questionnaires, and blood sampling for plasma biomarkers related to neurodegeneration and vascular pathology. MRI and OCT imaging are performed in selected cases. The cohort also includes healthy controls for comparison. Participants may undergo assessments across two visits, and their ability to consent is re-evaluated at each step. No therapeutic intervention is administered. The focus is on observational data collection for test development and biomarker correlation.
结局指标
主要结局
Development and Validation of a Consent Capacity Assessment Tool in Neurocognitive Disorders
时间窗: 09/25 - 09/26
Development and validation of a brief, standardized tool to assess decision-making and consent capacity in individuals with neurocognitive disorders, benchmarked against the MacCAT-T and supported by cognitive, behavioral, and biomarker data.
次要结局
- Correlation Between Consent Capacity and Neurobiological Markers(09/25 - 09/26)
研究者
Carolin Kurz
Dr. med. Carolin Kurz & Paulina Tegethoff M.Sc.
Ludwig-Maximilians - University of Munich