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 range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Alzheimer Disease trials