F00.1
Conditions
Interventions
Group 1: Arm title:
Participants with neurocognitive disorders
Description:
This arm includes individuals aged =50 years with neurocognitive disorders (e.g., Alzheimer’s disease and mixed forms). Par
Sponsors
LMU Klinikum
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development and Validation of a Consent Capacity Assessment Tool in Neurocognitive Disorders 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation Between Consent Capacity and Neurobiological Markers Secondary Outcome Description (max 250 characters): Examine associations between consent capacity scores and neurobiological markers, including plasma biomarkers (e.g., pTau217, NfL, GFAP) and retinal imaging findings (e.g., pRNFL, GCL) obtained via OCT in collaboration with the ophthalmology department. | — |
Countries
Germany
Contacts
Public ContactPaulina Tegethoff
LMU Klinikum
Outcome results
None listed