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

April 13, 2026 updated by: Carolin Kurz, Ludwig-Maximilians - University of Munich

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80336
        • Department of Psychiatry and Psychotherapy, LMU Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The DECISION study will recruit a well-characterized cohort of 100-150 adult participants, including individuals with neurocognitive disorders as well as cognitively healthy controls. The primary focus is on individuals aged 50 years and older with suspected or confirmed diagnoses of Alzheimer's disease (AD), frontotemporal dementia (FTD), vascular dementia, or mixed neurodegenerative pathologies. Participants may present with early-stage cognitive decline, including mild cognitive impairment (MCI), or more advanced stages of dementia.

Participants will primarily be recruited from existing clinical studies conducted at LMU University Hospital, including the AmyClear and ActiGlia cohorts. These individuals have previously undergone extensive diagnostic workups, including cerebrospinal fluid (CSF) biomarker and PET analyses.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Development and Validation of a Consent Capacity Assessment Tool in Neurocognitive Disorders
Time Frame: 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.
09/25 - 09/26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation Between Consent Capacity and Neurobiological Markers
Time Frame: 09/25 - 09/26

Secondary Outcome Description (max 250 characters):

Examine associations between consent capacity scores and neurobiological markers, including plasma biomarkers (e.g., pTau217, NfL, GFAP) and retinal imaging findings (e.g., pRNFL, GCL) obtained via OCT in collaboration with the ophthalmology department.
09/25 - 09/26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ludwig-Maximilians - University of Munich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carolin Isabella Kurz, M.D., Department of Psychiatry and Psychotherapy, LMU Hospital
  • Principal Investigator: Paulina Tegethoff, M.Sc., Department of Psychiatry and Psychotherapy, LMU Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LudwigsMaximilians
  • 25-0177 (Other Identifier: Department of Psychiatry and Psychotherapy, LMU hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to the sensitivity of health-related and cognitive data in a vulnerable population. The dataset includes pseudonymized but potentially re-identifiable information, and broad data sharing would exceed the scope of participants' informed consent. Sharing is restricted to protect privacy and comply with data protection regulations (e.g., GDPR). Access may be granted upon reasonable request and ethics approval under controlled conditions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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