An observational study in Alzheimer Disease and Neurodegenerative Diseases, sponsored by Ludwig-Maximilians - University of Munich. Active, not recruiting at 1 site in Germany. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Ludwig-Maximilians - University of Munich · Observational
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:
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.
Title: DECISION Study: Ethical Consent and Cognitive Decline Assessment in Dementia Detailed Study Description (Design-Focused)
Background and Rationale The ability to provide informed consent is central to ethical research participation and clinical decision-making. However, in individuals with neurocognitive disorders, such as Alzheimer's disease (AD), frontotemporal dementia (FTD), or vascular dementia, this capacity is often compromised. The fluctuating nature of cognitive symptoms, especially in early and mixed dementia presentations, complicates standardized assessments. Currently used instruments, such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), are comprehensive but not suited for rapid clinical decision-making or large-scale implementation.
Emerging therapeutic interventions and increased demand for early diagnosis necessitate scalable, valid instruments to assess capacity. DECISION seeks to close this gap by developing a tool grounded in neuropsychological theory, clinical practicality, and ethical and legal acceptability.
Objectives
Primary Objective:
Secondary Objectives:
Study Design The DECISION study is structured as a two-phase, prospective cohort study with mixed-methods integration.
Phase 1: Tool Development and Validation
Methodology:
Biomarkers:
Inclusion/Exclusion Criteria
Outcomes and Statistical Analysis
Timeline
Conclusion The DECISION study aims to create a scalable, evidence-based tool for assessing capacity to consent in cognitively impaired individuals. Its integration of neuropsychology, clinical practice, ethics, and biology positions it as a model for future dementia care and research protocols.
3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.
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The DECISION study will recruit a well-characterized cohort of 100-150 adult participants, including individuals with neurocognitive disorders as well as cognitively healthy controls. The primary focus is on individuals aged 50 years and older with suspected or confirmed diagnoses of Alzheimer's disease (AD), frontotemporal dementia (FTD), vascular dementia, or mixed neurodegenerative pathologies. Participants may present with early-stage cognitive decline, including mild cognitive impairment (MCI), or more advanced stages of dementia.
Participants will primarily be recruited from existing clinical studies conducted at LMU University Hospital, including the AmyClear and ActiGlia cohorts. These individuals have previously undergone extensive diagnostic workups, including cerebrospinal fluid (CSF) biomarker and PET analyses.
Exclusion Criteria:
This cohort includes 100-150 individuals aged 50 and above with varying degrees of neurocognitive impairment, including Alzheimer's disease, frontotemporal dementia, vascular dementia, and mixed forms. Participants are recruited from prior studies (e.g., AmyClear, ActiGlia) with existing diagnostic data such as CSF biomarkers and PET imaging. The primary aim is to assess and validate a novel, scalable instrument for evaluating consent capacity. Interventions are non-invasive and include cognitive testing, questionnaires, and blood sampling for plasma biomarkers related to neurodegeneration and vascular pathology. MRI and OCT imaging are performed in selected cases. The cohort also includes healthy controls for comparison. Participants may undergo assessments across two visits, and their ability to consent is re-evaluated at each step. No therapeutic intervention is administered. The focus is on observational data collection for test development and biomarker correlation.
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.
Time frame: 09/25 - 09/26
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.
Time frame: 09/25 - 09/26
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data (IPD) will not be shared due to the sensitivity of health-related and cognitive data in a vulnerable population. The dataset includes pseudonymized but potentially re-identifiable information, and broad data sharing would exceed the scope of participants' informed consent. Sharing is restricted to protect privacy and comply with data protection regulations (e.g., GDPR). Access may be granted upon reasonable request and ethics approval under controlled conditions.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Ludwig-Maximilians - University of Munich