MedTrace Logo

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

NCT07514520 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Carolin Isabella Kurz, M.D. · Department of Psychiatry and Psychotherapy, LMU hospital

  • Paulina Tegethoff, M.Sc. · Department of Psychiatry and Psychotherapy, LMU hospital

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2026-09-01
Completion
2026-10-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07514520 on ClinicalTrials.gov