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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Development and Validation of a Consent Capacity Assessment Tool in Neurocognitive Disorders — 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.
Trial sites (1)
Facility
City
Region
Status
Department of Psychiatry and Psychotherapy, LMU Hospital
Munich
Bavaria
More Ludwig-Maximilians - University of Munich trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.