NCT07514520Active, not recruiting
Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline - DECISION
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- 2 Oct 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Diseases
- Alzheimer disease
- NCT number
- NCT07514520
What you commit to
- Study type: Observational
- Planned participants: 100
- From 2 Oct 2025 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Severe sensory impairments (e.g., blindness, deafness) that prevent completion of assessments
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Psychiatry and Psychotherapy, LMU Hospital Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.