Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline - DECISION
Conditions: Alzheimer Disease, Neurodegenerative Diseases
Sponsor: Ludwig-Maximilians - University of Munich

Klinik und Poliklinik für 
Psychiatrie und Psychotherapie 
Decision Study Protocol Version 4.0 – Stand 13.04.2026 
 
 
 
Official Title: 
Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline (DECISION) 
 
Brief Title: 
DECISION 
 
NCT Number: 
NCT07514520 
 
Document Date: 
13th April 2026 
 
 
 
 
 
 

Klinik und Poliklinik für 
Psychiatrie und Psychotherapie 
 
Klinik und Poliklinik für Psychiatrie und Psychotherapie 
Nußbaumstraße 7, 80336 München 
 
 
 
Direktor
Prof. Dr. med. Peter Falkai 
 
Ihr Ansprechpartner 
Dr. med. Carolin Kurz 
Fachärztin für Neurologie und 
Psychiatrie  
Tel. +49 89 4400-55785 
Fax +49 89 4400-55808 
carolin.kurz@ 
med.uni-muenchen.de 
www.lmu-klinikum.de 
 
Ethikkommission bei der Medizinischen 
Fakultät LMU München 
Pettenkoferstr. 8a 
80336 München 
 
 
 
 
 
 
 
 
 
 
 
 
 
APPLICATION FOR ETHICAL APPROVAL 
 
‘ 
Decision-making, Ethical Consent, and Interactive Dialogue in 
Ongoing Neurocognitive Decline - DECISION 
 
 
 
 
 
 
 
 
Version 4.0 (07-07-2025) 
CAROLIN KURZ & PAULINA TEGETHOFF 
DEPARTMENT OF PSYCHIATRY AND PSYCHOTHERAPY 
LMU HOSPITAL MUNICH 
NUSSBAUMSTR. 7 
80336 MUNICH 
 
 
Datum
22.05.2025 
 

Klinik und Poliklinik für 
Psychiatrie und Psychotherapie 
 
 
DECISION: Decision-making, Ethical Consent, and Interactive 
Dialogue in Ongoing Neurocognitive Decline 
 
Project Sketch  
As the ability to consent to study participation may be limited in patients with 
Alzheimer's disease (AD) or related disorders, a precise assessment is essential. 
However, no standardized procedure exists, despite evidence that consent capacity 
fluctuates in psychiatric disorders, particularly dementia. The MacArthur Competence 
Assessment Tool (MacCAT-T) is effective but impractical for routine clinical use due 
to its complexity. (1) This study aims to develop a simple yet valid instrument for 
assessing consent capacity in patients with neurodegenerative and vascular dementia, 
applicable to broader psychiatric settings. Legally, consent capacity requires insight, 
judgment, and control. These aspects should be operationalized using attention, 
language comprehension, risk assessment, and situational transfer, structured in a 
graduated, easily comprehensible format. (2) To validate our findings, we will use the 
MacCAT-T as a reference alongside the Clinical Dementia Rating (CDR) for overall 
cognitive function. (3) Additionally, the Cognitive Failures Questionnaire (CFQ) will be 
examined as a potential screening tool to identify individuals requiring further consent 
capacity evaluation. (4) Furthermore, we will investigate the correlation between 
vascular and neurodegenerative lesions and consent capacity. Using a 3 Tesla MRI at 
the Department of Psychiatry, we will analyze associations between regional nerve cell 
loss and microbleeds. Biomarkers of neurodegeneration and vascular damage, 
including platelet-derived growth factor, fibrinogen, pentraxin, and vascular growth 
factor, will be assessed using the Lumipulse platform (Fujirebio) at the Department of 
Laboratory Medicine. 
 
As treatments for early AD emerge, there is a growing need for efficient, scalable 
cognitive assessments. Digital cognitive test batteries offer a promising solution, 
enabling early detection of mild cognitive impairment, subjective cognitive decline, and 
dementia. Digitalization can facilitate the widespread implementation of these 
assessments, making them more accessible and applicable in clinical practice. 
 
Major aims 
Primary endpoint: Development of a reusable procedure for assessing the capacity to 
consent that can also be transferred to other areas of psychiatry 
Secondary endpoint: Investigation of whether and to what extent vascular and 
neurodegenerative lesions correlate with a restriction of the ability to give consent. 
 
This study addresses the challenge that although capacity to consent is a multifaceted 
construct involving interacting factors such as language, attention, understanding of 
the problem, and ability to apply these to one's own situation, it is currently assessed 
using standardized methods and is left to the subjective judgement of individual 
clinicians. Currently, capacity to consent is assessed using non-standardized methods 
and is left to the subjective judgement of individual clinicians. 
 
 

Klinik und Poliklinik für 
Psychiatrie und Psychotherapie 
 
 
Responsibilities and Funding 
 
Principal 
investigator 
Dr. med. Carolin Kurz, specialist in neurology and psychiatry 
Department of Psychiatry and Psychotherapy 
Ludwig-Maximilians-University Hospital Munich, Munich 
✉ carolin.kurz@med.uni-muenchen.de
Principal 
investigator 
Paulina Tegethoff, M.Sc. Psychologist 
Department of Psychiatry and Psychotherapy  
Ludwig-Maximilians-University Hospital Munich, Munich 
✉ paulina.tegethoff@med.uni-muenchen.de
Co-investigator 
Univ.-Prof. Dr. med. Robert Perneczky 
Professor of Translational Dementia Research and Director, 
Division of Geriatric Psychiatry and Alzheimer’s Therapy and 
Research Center, Department of Psychiatry and Psychotherapy 
Ludwig-Maximilians-University Hospital Munich, Munich 
✉ robert.perneczky@med.uni-muenchen.de 
Co-investigator 
Dr. med. Anna Hufnagel 
Department of Psychiatry and Psychotherapy  
Ludwig-Maximilians-University Hospital Munich, Munich 
✉ anna.hufnagel@med.uni-muenchen.de 
Co-investigator 
Dr. med. Leonie Keidel 
Department of Ophthalmology  
Ludwig-Maximilians-University Hospital Munich, Munich 
✉ leonie.keidel@med.uni-muenchen.de 
Study center 
Department of Psychiatry and Psychotherapy 
Ludwigs-Maximilians-Universität München  
Funding 
This study is funded by the Pesl Alzheimer Stiftung.  
 
 
Scientific Background 
Especially in patients with Alzheimer's disease (AD), vascular encephalopathies or 
mixed forms of dementia, the ability to give consent can be impaired even in the early 
stages of the disease, which poses a considerable challenge for diagnostic and 
therapeutic care. (5) (6) (7) (8) Frontal and parietal networks are crucial for self-
perception, error judgement and information integration. (9) Their damage, e.g. due to 
vascular lesions or neurodegenerative diseases such as AD, Lewy body dementia or 
frontotemporal dementia, can lead to anosognosia. (10) This symptom complicates 
the assessment of capacity to consent, as it impairs the realistic assessment of one's 
own illness and its consequences. In addition to the capacity for insight, the 
judgement and control skills necessary for informed decisions are also affected. The 

Klinik und Poliklinik für 
Psychiatrie und Psychotherapie 
 
consideration of anosognosia is therefore of central importance in the development of 
an assessment instrument. 
 
Study design 
This study is designed as a prospective cohort study to develop and validate a 
structured assessment tool for consent capacity. The study consists of multiple steps, 
beginning with the identification of potential risk groups through screening, followed 
by detailed psychometric testing, item selection for test refinement, and validation 
against established gold-standard measures. By systematically evaluating cognitive 
and neuropsychological characteristics, we aim to create an accessible, efficient, and 
valid assessment instrument. 
 
For the DECISION study, a clearly defined, heterogeneous sample of 100–150 
individuals will be recruited, including persons with limited capacity to give consent. All 
participants will be accompanied by a trusted individual who can provide information 
about their everyday functioning. Participants will be specifically recruited from the 
ActiGlia and Amy-Clear studies (project numbers 17-755, 17-569, and 18-606), for 
which comprehensive neuropsychological, clinical, and biomarker-based diagnostics 
(e.g. cerebrospinal fluid analysis and amyloid/tau PET imaging) have already been 
performed. Where available, these existing diagnostic results will be re-used with the 
participants’ informed consent, in order to avoid additional invasive procedures such 
as repeat lumbar punctures. This approach ensures a high degree of diagnostic 
accuracy while minimizing participant burden. The strictly defined selection process 
will create a reliable foundation for test development. This careful recruitment strategy 
will ensure both diagnostic precision within the Alzheimer’s continuum and the 
inclusion of a robust, well-characterized comparison group. 
 
Phase 1: Neuropsychological operationalisation of consent capacity 
Phase 1 focuses on the neuropsychological development and validation of this test 
procedure. To this end, we specifically assess cognitive domains that are related to 
decision-making ability: attention, executive functions, cognitive flexibility, language 
comprehension and production, risk assessment, cognitive complaints, as well as 
aspects of decision-making behaviour and problem-solving ability. 
 
Questionnaires and screening instruments 
 Cognitive Failures Questionnaire (CFQ): Assesses subjectively experienced 
cognitive impairments in everyday life (e.g. forgetfulness, distractibility, 
impulsive behaviour) and is also suitable for the early detection of atypical 
forms of dementia (e.g. frontotemporal or vascular dementia). (4) 
 Subjective Cognitive Decline Questionnaire (SCD-Q): Assesses subjectively 
perceived cognitive changes compared to previous performance levels, 
particularly in relation to memory, attention and language, to identify individuals 
at risk of developing Alzheimer's disease. (11) (12) 
 Dysexecutive Syndrome – External Rating (DEX-F): Assesses changes in 
executive functioning, such as impulse control, planning, problem solving and 
emotion regulation, through external assessment by relatives or professional 
caregivers. (13) (14) 

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Gold standard for validation 
 MacArthur Competence Assessment Tool for Treatment (MacCAT-T): Serves 
as an established reference standard for assessing capacity to consent. (7) 
 Clinical Dementia Rating (CDR): Used for comprehensive assessment of the 
severity of cognitive impairments. The CDR evaluates six functional areas (e.g. 
memory, orientation, judgement, social skills) based on external and self-
assessments. (8) 
 Clock drawing test (CDT): used as a screening tool; errors may indicate 
impaired consent capacity in Alzheimer’s disease (15) (16) 
 
Neuropsychological test battery (‘DECISION test battery’) 
 Aachen Aphasia Test (AAT) for the targeted assessment of language skills: (17) 
o Token test (language comprehension) 
o Spontaneous speech analysis (linguistic expression based on a picture) 
o Written language (reading and writing skills) 
 Trail Making Test A/B (TMT): Assesses attention and cognitive flexibility. (18) 
(19) 
 DOSPERT: Assesses risk perception and decision-making behaviour in various 
everyday contexts. (20) 
 PCRS (Patient Competency Rating Scale): Assesses insight into illness from the 
patient's own perspective and that of others. (21) 
 Hooper Visual Organization Test (VOT): Assesses visual object recognition and 
integration using fragmented images of everyday items (e.g., a disassembled 
chair). (22) 
 
The modules provide a comprehensive picture of decision-making ability, including 
subjective, linguistic and behavioural aspects. Language tests are central to this, as 
language is fundamental to understanding medical information and formulating 
decisions. Aspects such as insight, values and emotional stress are assessed by other 
components of the test battery. 
 
Validation Concept (Phase 1) 
In Phase 1, several types of validity will be examined to ensure the robustness and 
practical relevance of the DECISION tool. The following validation strategies will be 
applied: 
 
Criterion validity will be assessed by comparing the results of the DECISION tool with 
those of a recognized gold standard—the MacArthur Competence Assessment Tool 
for Treatment (MacCAT-T). Correlational and regression analyses will be conducted, 
with a correlation coefficient (r) greater than .5 and a significance level (p) 
below .05 servingas the benchmarks for sufficient criterion validity.Construct 
validity will be evaluated by analyzing the relationship between the DECISION tool and 

Klinik und Poliklinik für 
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various cognitive measures, including the Trail Making Test A/B (TMT A/B), the Action 
Affinity Task (AAT), the Domain-Specific Risk-Taking Scale (DOSPERT), the Cognitive 
Failures Questionnaire (CFQ), and the Patient Competency Rating Scale (PCRS). 
Correlation and factor analyses will be used. Correlations above .3 and theoretically 
consistent patterns will be considered indicative of construct validity. To examine 
convergent validity, the DECISION tool will be compared to other established 
instruments assessing judgment capacity. Correlational and regression analyses will 
be carried out, and convergent validity will be assumed if correlations exceed .4 (r > .4),  
 
the results are statistically significant (p < .05), and the associations are conceptually 
sound. Discriminant validity will be tested by comparing individuals with Alzheimer’s 
disease (diagnosed based on biomarker evidence) to healthy controls. ROC analysis, 
AUC values, and t-/U-tests will be used. An AUC above .80 and sensitivity/specificity 
values above 75% will be considered indicative of strong discriminative power. To 
confirm structural validity, the internal structure of the DECISION subtests will be 
examined using factor analysis. Structural validity will be assumed if the model 
explains more than 50% of the variance and if items clearly load on the expected 
factors. 
 
Additionally, we aim to identify relevant items from the subtests and examine the 
possibility of shortening the tests. We also seek to integrate the naming and language 
comprehension assessment into a single test to streamline the evaluation process. 
 
The short version of an informed consent scale, consisting of subcomponents from 
the Trail Making Test (TMT A & B), the subtests from the Aachener Aphasia Test 
(Token-Test and Naming), the Domain-Specific Risk-Taking Scale (DOSPERT), and the 
Problem Solving Inventory for Adults (PSI-A), which was tested with existing informed 
consent questionnaires, will be re-presented to the relevant patient group. 
 
For the DECISION study, a clearly defined, heterogeneous sample of 100–150 people 
will be recruited, including those with limited capacity to give consent. All participants 
will be accompanied by a trusted individual who can provide information about their 
everyday functioning. Participants will be specifically recruited from the ActiGlia and 
AmyClear studies (project numbers 17-755, 17-569 and 18-606), for which 
comprehensive neuropsychological, clinical and biomarker-based diagnostics (e.g. 
cerebrospinal fluid analysis and amyloid/tau PET imaging) have already been 
performed. This will enable precise classification within the Alzheimer's continuum or 
as healthy controls. The strictly defined selection process creates a reliable basis for 
test development. This careful selection ensures high diagnostic certainty within the 
Alzheimer's continuum and a robust comparison group. 
 
Co-design approach 
The process development follows a participatory co-design approach that consistently 
incorporates the perspectives of people with cognitive impairments. The aim is 
research on an equal footing – with shared responsibility, barrier-free participation and 
competence promotion. Co-design strengthens motivation, enables early identification 
of obstacles and allows for iterative adaptation. Findings from interviews with affected 

Klinik und Poliklinik für 
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individuals, relatives and carers are incorporated into the comprehensibility, relevance 
and practicality of the modular test battery. 
 
 
 
Guided interviews and medical practice perspectives 
In addition, focus groups and guided interviews are conducted with medical 
professionals who regularly decide on the capacity to give consent. Standardized case 
vignettes are used to record decision-making processes, uncertainties and routines. 
The aim is to derive practical requirement profiles that are directly incorporated into 
the development of the test items and ensure the clinical applicability of the 
procedure. In the long term, this will result in an evidence-based, practical instrument 
for assessing consent capacity. ‘The focus groups with medical professionals will be 
recruited separately via a standardised invitation letter. Separate informed consent will 
be obtained. Audio recordings will be stored pseudonymously, archived with password 
protection and deleted after completion of the evaluation.’ 
 
Legal evaluation and interdisciplinary integration 
The procedure will be evaluated from a legal perspective to strengthen its legal 
applicability.  The legal evaluation of the informed consent procedure will be 
conducted by an external specialist in medical law with specific expertise in research 
ethics and dementia-related consent issues. 
Medical, ethical and legal requirements for the ability to give consent will be 
systematically incorporated into the development process through accompanying 
consultations and feedback on item formulations. 
 
Phase 2 – Neurobiological markers of impaired capacity to consent 
Phase 2 of the DECISION project will investigate whether plasma-based 
neurobiological early warning signs (‘red flags’) can be identified that are associated 
with impaired capacity to consent in people with cognitive impairments. The aim is to 
develop a biomarker-based stratification for the early detection of cognitive and 
functional impairments.  
 
Plasma-based biomarkers 
The focus is on low-threshold, laboratory-based methods that can also be used in 
outpatient settings and without complex diagnostic equipment. The following 
biomarkers, which are currently being investigated in connection with 
neurodegenerative processes, are being examined: (23) 
 
 Amyloid pathology: plasma levels of Aβ1-42/1-40 
 Tau pathology: phosphorylated tau (pTau217) 
 Neurodegeneration: neurofilament light chain (NfL) 
 Glial activation (GFAP) as a marker for later stages of the disease 
 Apolipoprotein E4: high correlation with the genetic ApoE4 genotype and thus 
an indirect, non-invasive risk marker for faster progression 
 

Klinik und Poliklinik für 
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These markers are correlated with specific functional impairments – particularly in the 
areas of judgement, insight into illness, decision-making behaviour and other 
dimensions that are mapped by the modular test battery. 
 
 
Magnetic resonance imaging 
The aim of the imaging-related part of the project is to identify biologically plausible 
risk constellations associated with impaired capacity to give informed consent in 
people with cognitive impairments. 
 
The following will be systematically investigated: 
Temporomesial atrophy as a marker of progressive memory impairment, 
Vascular lesions as an indication of subcortical dysfunction and executive 
impairments, 
Structural and functional changes in prefrontal and temporoparietal networks that are 
essential for insight, judgement and decision-making behaviour. 
 
Optical coherence tomography (OCT) 
As part of the study, structural and functional markers of neurodegeneration will be 
recorded using optical coherence tomography (OCT) in cooperation with the 
Department of Ophthalmology. A comprehensive ophthalmological examination will be 
performed. It includes slit lamp biomicroscopy, fundoscopy, Goldmann applanation 
tonometry and best-corrected visual acuity (BCVA) using the standard ETDRS chart at 
a testing distance of four meters. An SD-OCT system (Spectralis®; Heidelberg 
Engineering GmbH, Heidelberg, Germany) is used for B-scan acquisition. The 
peripapillary retinal nerve fiber layer (pRNFL) will be measured with activated eye 
tracker using ring scans around the optic nerve head (12°, resolution: 768 A-scans, 496 
pixels [Z], 57 ≤ ART ≤ 100) or the most inner ring of a star-and-ring scan around the 
optic nerve (12°, resolution: 768 A-scans, 496 pixels [Z], 57 ≤ ART ≤ 100). The 
volume data for the ganglion cell layer (GCL) and inner plexiform layer (IPL) will be 
calculated as a 3 mm diameter cylinder centered to the fovea derived from a macular 
volume scan (20° × 20° [5.9 × 5.9 mm], 49 horizontal B-scans, resolution: 512 
pixels [X] × 496 pixels [Z], 18 ≤ ART ≤ 30). 
and retinal pulsatility as a marker of vascular dysfunction, using Doppler-based 
techniques such as phase-resolved Doppler OCT (?hat Bene etwas dazu gesagt, habe 
noch nie davon gehört) Via optical coherence tomography angiography (OCT-A) ocular 
blood flow will be assessed. Structural imaging will focus on macular and peripapillary 
regions, while functional parameters will be assessed in the fovea centralis. This 
approach builds on previous work combining OCT and electrophysiological markers in 
psychiatric populations (24) and is further motivated by evidence linking Alzheimer’s 
disease and glaucoma via shared mechanisms such as impaired glymphatic 
clearance and disturbed CSF dynamics. (25) Combined imaging and pressure 
assessment is expected to provide novel insights into the retina as a potential window 
into central nervous system pathology. 
 
Laboratory tests 

Klinik und Poliklinik für 
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To rule out alternative, potentially treatable causes of optic atrophy, a standardized 
laboratory screening will be conducted. This will include serum levels of vitamin B12 
and folate (to exclude nutritional optic neuropathy), inflammatory markers (CRP, ESR) 
to detect systemic or autoimmune inflammation, and syphilis serology (TPHA/FTA-
ABS) to rule out infectious causes. In participants showing atypical clinical features or 
progressive visual loss, extended laboratory testing will be performed, including 
vitamin B1 and copper levels, Borrelia serology, and HIV testing, depending on clinical 
context and risk factors. Evtl. Syphilis, ACE, IL-2, ANA, ANCA, Borrelia, Toxoplasmose 
eher auch in das extended workup, da sehr selten und meist nur bei entsprechender 
Anamnese/Klinik. 
 
Clinical examination  
Clinical diagnoses will be established according to ICD-10 criteria, based on a 
comprehensive assessment. This will include a standardized medical history and 
clinical examination, supported by relevant laboratory testing to rule out differential 
diagnoses (e.g., vitamin deficiencies, inflammation, infection). To assess 
neuropsychiatric comorbidity, all participants will complete a standardized depression 
questionnaire (e.g., Geriatric Depression Scale or Beck Depression Inventory), and 
cardiovascular risk factors will be evaluated using a validated cardiovascular risk score 
(e.g., Framingham Risk Score or SCORE2), as vascular comorbidity may influence 
optic nerve integrity and cognitive decline. These diagnostic components will ensure a 
well-characterized study population and allow for appropriate control of confounding 
factors in the analysis. 
 
To minimise participant burden, individuals will be contacted on only two occasions. 
During the first contact, they will complete a short cognitive test battery (approx. 15 
minutes), including measures of attention, executive function, and language. After a 
shortened version of this battery has been derived, participants will complete the 
revised version in a second session, which is expected to take no more than 10 
minutes. In addition, the MacCAT-T and CDR will be administered (approx. 25 and 30–
60 minutes, respectively) to validate the newly developed short version against 
established instruments. 
 
Ability of the participants to give consent 
Participants' capacity to consent will be assessed at the time of enrolment using 
proven and standardised procedures as described in the protocol (e.g. MacCAT-T). In 
the event that a participant loses capacity during the course of the study, it must be 
ensured that the consent of the legal guardian or authorised representative is 
obtained. This person must be authorised to make decisions on health matters. 
 
Figure 1 : Overview of the study processes 

Klinik und Poliklinik für 
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Study-related burden and risks 
For this study, former participants of the in-house AmyClear and ActiGlia trials, who 
have previously consented to be re-contacted, have caregivers, and are well-
characterized, will be re-contacted. These participants, as individuals with Alzheimer’s 
disease, are at the highest risk of losing their capacity to consent over time. To 
address this, each participant’s consent capacity will be reassessed using the 
MacArthur Competence Assessment Tool (MacCAT-T)at every stage of the study. 
Existing data including blood samples will be used if participants are no longer able to 
give informed consent or have borderline capacity. In such cases, only non-
invasive measures such as cognitive tests and questionnaires will be conducted, 
subject to the additional consent of a legally authorized carer. 
This approach minimises invasive procedures and reduces the burden on participants, 
while ensuring the ethical inclusion of people with limited capacity. It balances the 
need for robust scientific data with a strong commitment to the welfare of 
participants, and respects autonomy by relying on prior consent and carer supervision. 
Although the reliance on existing samples limits opportunities for the collection of new 
biomarkers, this approach prioritises ethical integrity and is consistent with the study's 
goals of optimising consent assessment thresholds. 
 
Risks of Blood draws 
Risk of drawing blood consist in damage of skin, surrounding tissue and nerves and 
are considered to be minimal. Chronic pain, infections, tissue necrosis, hematoma, 
edema, scars and sensory complaints and palsy are possible and chronic but rare 
complications of blood drawing.  
 
Potential burden on the participants 
From a psychological perspective, the mental burden experienced by the participants 
is considered to be low. A questionnaire can be completed at home. Among other 
things, to keep the burden minimal, the test instruments to be completed are 
distributed over two days, so that the time required for the first session in the clinic is a 
maximum of 40 minutes, and for the second session, it is a maximum of 60 to 90 
minutes. OCT imaging does not expose patients to radiation. 

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Information and transparency 
Participants must be comprehensively informed in advance about the objective, 
process, potential burdens and risks as well as how the results will be handled. A focus 
should be placed on comprehensible, accessible information in simple language. 
 
Privacy concerns 
Every digital application has the potential to compromise privacy. Privacy concerns 
regarding data regarding the data storage and security breaches could also pose risks, 
especially if personal data is involved. Since no personal information is entered into the 
digital application, we consider this risk to be low. We use servers located in the 
European Union that comply with European privacy laws. 
 
Informed consent and project ethics 
Weighing up possible risks and scientific meaning this study seems ethically 
legitimated if participants provide written consent. The risk of physical hazard seems 
very low. We anticipate that the potential data protection risks to project participants 
are only minimal, as no identifiable data will be exchanged or stored. The patients´ 
information sheet is added to this application. Any exchange of data will be in a non-
identifiable fashion to fully protect the anonymity and identity of the participants.  
 
Legal and ethical framework 
The study is based on the ethical principles of the Declaration of Helsinki as well as the 
general provisions of the German Civil Code (BGB) and guardianship law. Although 
Germany has not yet ratified the Convention on Human Rights and Biomedicine, 
Articles 16 and 17 provide guidelines for the design of ethically acceptable studies. 
Group-related benefits and the preservation of autonomy take centre stage here. 
 
Benefit 
Participants will benefit from personalized feedback on their results, access to 
educational materials, and insights into their decision-making abilities. Their 
involvement directly contributes to improving future healthcare and decision-making 
evaluations, providing both group and potential individual benefits. Participants may 
also receive access to counseling resources, small compensation, or referrals to 
appropriate care if needed. 
 
Dealing with relevant results 
If the analysis provides biomarkers or other results of clinical relevance, participants 
must be informed of this if they have agreed to be contacted during the consent 
process. An appropriate counselling process must be ensured for the disclosure of 
this information, which also includes the communication of necessary measures or 
treatment options. 
 
Expected results 
 
Association between a newly developed, low-effort test battery and the Mac-
CAT-T in reliably assessing decision-making capacity 
 
Link between vascular changes and reduced capacity to consent, independent 
of the dementia subtype 

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 
Relationship between lesions in key cognitive regions (e.g., attention, language 
comprehension, information processing) and impaired decision-making 
capacity, regardless of the underlying condition 
 
Clinical Work-up 
Dementia diagnostics will be performed following the standard diagnostic work-up of 
the Alzheimer Therapie- und Forschungszentrum, which includes psychometric tests, 
neuroimaging, clinical evaluation, and, depending on medical indication, cerebrospinal 
fluid biomarkers and positron emission tomography scans. Blood drawing and clock 
drawing test will be the only study-related procedures that will be additionally 
introduced and it will take 5 to 10 minutes to complete.  
 
Setting 
Alzheimer Therapie- und Forschungszentrum – University Hospital, LMU Munich 
 
Duration of the study  
09/2025 – 03/2027 
 
Use of Existing Data for Correlational Analyses 
Participants from the AmyClear and ActiGlia studies (project numbers 17-755, 17-569, 
18-606), who have already undergone extensive diagnostic work-ups—including CSF 
analysis and PET imaging—will be recontacted. With the participants’ explicit consent, 
these existing data will be reused to avoid unnecessary repetition of invasive 
procedures such as lumbar puncture or PET scans. This reuse is essential for the 
accuracy of clinical classification within the Alzheimer’s continuum and reflects our 
ethical obligation to minimize participant burden. We therefore request that 
participants provide specific consent to the reuse of previously collected imaging and 
biomarker data (CSF, PET) for the DECISION study.  
 
Data management and protection 
The protection of sensitive patient data must be strictly guaranteed. Data processing 
is pseudonymised and in accordance with the applicable data protection regulations. 
To maintain participant confidentiality, each participant will be assigned a unique 
participant identifier (consecutive number) by the study coordinator upon enrolment, 
which will be used for all subsequent data analysis and reporting. The participants’ 
personal details (e.g. name and contact data) will be stored in a separate database in a 
secure encrypted environment, not connected to the internet. All personal information 
will be destroyed immediately after the completion of the study, unless the participant 
explicitly agrees to be contacted for future related research, in which case the personal 
information will be stored for up to 5 years after study completion. Only the study 
coordinator and principal investigator have access to the personal information. De-
pseudonymization would only be permissible in case of significant participant safety 
concerns. All involved parties will ensure protection of participant personal data and 
will not include participant names on any study forms, reports, publications, or in any 
other disclosures, except where required by law. In accordance with regulations, 
participants will be informed about data handling procedures. 
 

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All study data will be stored and processed within the Medical Data Integration Center 
(MeDICLMU) at LMU University Hospital. MeDICLMU is part of the nationwide Medical 
Informatics Initiative and provides the technical and organizational infrastructure for 
secure, GDPR-compliant integration and exchange of clinical and research data across 
institutions. Data processing will be conducted in a pseudonymized manner in 
accordance with applicable data protection regulations. The use of participant data for 
scientific purposes, including correlational analyses, is explicitly outlined in the 
informed consent form.  
 
Requests for data access within the scope of scientific research are subject to review 
by the LMU Hospital’s Use & Access Committee (UAC).  
 
Contact: uac@med.uni-muenchen.de  
 
This infrastructure ensures the secure, transparent, and ethically responsible use of 
sensitive health data in medical research. 
 
 
 
Summary 
The proposed study meets the essential criteria for ethically acceptable research. The 
benefits of the study, both at the individual and group level, outweigh the potential 
risks, provided that the above measures are consistently implemented. In particular, 
the review of the capacity to give consent and the information provided to participants 
in the event of clinically relevant results strengthen the ethical basis of the project. The 
framework of the study has been developed in close dialogue with the ethics 
committee. 
 
Signatures of investigators 
 
Principle Investigator Dr. med. Carolin Kurz  
 
Principle Investigator Paulina Tegethoff  
 
 

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References 
 
1. 
Grisso TA, Paul S. Assessing Competence to Consent to Treatment: A Guide for Physicians and Other 
Health Professionals. New York: Oxford University Press; 1998. 
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