Active — Not RecruitingNot Applicable

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

Germany100 participantsStarted 2025-10-02

Plain-language summary

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.

Who can participate

Age range50 Years

SexALL

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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

What they're measuring

Development and Validation of a Consent Capacity Assessment Tool in Neurocognitive Disorders

Timeframe: 09/25 - 09/26

Trial details

NCT IDNCT07514520

SponsorLudwig-Maximilians - University of Munich

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09-01