Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline - DECISION

Ludwig Maximilian University of Munich

Status: Active, not recruiting

Conditions: Alzheimer Disease; Neurodegenerative Diseases

Study type: Observational

Funder types: Other

Identifiers

NCT07514520

LudwigsMaximilians

25-0177 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Title: DECISION Study: Ethical Consent and Cognitive Decline Assessment in Dementia Detailed Study Description (Design-Focused)

1. 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.

   Secondary Objectives:

   • Validate the tool against established standards (e.g., MacCAT-T).
   • Examine the relationship between cognitive domains (e.g., language, attention) and decision-making.
   • Investigate correlations between neurodegenerative and vascular biomarkers and consent capacity.

3. Study Design The DECISION study is structured as a two-phase, prospective cohort study with mixed-methods integration.

   Phase 1: Tool Development and Validation

   • Sample: 100-150 participants (patients with varying dementia subtypes and healthy controls).

   • Methodology:

     • Comprehensive neuropsychological profiling
     • Test item development from domains critical to decision-making (attention, executive function, language comprehension, risk assessment)
     • Use of MacCAT-T and Clinical Dementia Rating (CDR) for validation
     • Comparison of subjective and informant-reported measures (e.g., Cognitive Failures Questionnaire, Dysexecutive Questionnaire)

   • Output: A modular test battery with a shortened, clinically usable version Phase 2: Neurobiological Correlates

   • Objective: Identify biomarkers associated with impaired consent capacity

   • Biomarkers:

     • Blood-based (e.g., pTau217, NfL, GFAP, Aβ1-42/1-40)
     • Structural MRI (temporal, frontal, and parietal regions)
     • Optical coherence tomography (OCT) for retinal changes

   • Analysis: Correlation with DECISION test battery performance and clinical indicators

4. Recruitment Strategy Participants will be selected from previous cohorts (AmyClear and ActiGlia), allowing access to existing CSF, PET, and neuropsychological data. All participants will be re-consented and evaluated using standardized tools at baseline. If capacity is limited, a legal guardian or proxy will be engaged per ethical protocols.

5. Inclusion/Exclusion Criteria

   • Adults aged 50+
   • Diagnosed or suspected cognitive impairment (per ICD-10 criteria)
   • Able to provide consent or have a legal representative
   • No severe sensory impairments interfering with testing

6. Ethical Framework The study follows the Declaration of Helsinki and German civil law (BGB). All assessments are designed to be minimally invasive, with an emphasis on autonomy, transparency, and participant safety. Focus groups with medical professionals and interviews with patients will inform test development.

7. Co-Design and Participatory Approach Patients and caregivers contribute to item design and language accessibility. Medical professionals help ensure clinical relevance. Legal advisors assess conformity with consent standards.

8. Outcomes and Statistical Analysis

   • Primary endpoint: Validity and reliability of the new tool compared to MacCAT-T
   • Secondary endpoints: Biomarker correlations, subgroup analyses (e.g., dementia type, anosognosia presence)
   • Analytical methods: Correlation, regression, factor analysis, ROC curves, AUC calculations

9. Data Handling and Security Data will be pseudonymized and stored within the MeDICLMU infrastructure. Personal identifiers are kept separate and encrypted. Access is limited to the study team. Data usage will comply with GDPR.

10. Timeline

    • Study start: September 2025
    • End of recruitment: March 2026
    • Final assessments and analysis: March 2027

11. Dissemination Results will be published in peer-reviewed journals and presented at international conferences. A clinical guideline for using the consent assessment tool will be developed.

Conclusion The DECISION study aims to create a scalable, evidence-based tool for assessing capacity to consent in cognitively impaired individuals. Its integration of neuropsychology, clinical practice, ethics, and biology positions it as a model for future dementia care and research protocols.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

100 participants in 1 patient group

Individuals with AD spectrum for consent capacity and biomarker validation study

Description:

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.