Alzheimer DiseaseDECISIONNCT07514520
Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline - DECISION
An observational study of Alzheimer Disease and Neurodegenerative Diseases, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Neurodegenerative Diseases
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 2 Oct 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, LMU Hospital
Munich, Bavaria, 80336
About this study
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.
Read more
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.
Read the detailed description
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:
- Develop a standardized, brief, and reusable tool to assess capacity to consent in individuals with neurocognitive disorders. Secondary Objectives:
- Validate the tool against established standards (e.g., MacCAT-T).
- Examine the relationship between cognitive domains (e.g., language, attention) and decision-making.
- Investigate correlations between neurodegenerative and vascular biomarkers and consent capacity.
- Study Design The DECISION study is structured as a two-phase, prospective cohort study with mixed-methods integration. Phase 1: Tool Development and Validation
- Sample: 100-150 participants (patients with varying dementia subtypes and healthy controls).
- Methodology:
- Comprehensive neuropsychological profiling
- Test item development from domains critical to decision-making (attention, executive function, language comprehension, risk assessment)
- Use of MacCAT-T and Clinical Dementia Rating (CDR) for validation
- Comparison of subjective and informant-reported measures (e.g., Cognitive Failures Questionnaire, Dysexecutive Questionnaire)
- Output: A modular test battery with a shortened, clinically usable version Phase 2: Neurobiological Correlates
- Objective: Identify biomarkers associated with impaired consent capacity
- Biomarkers:
- Blood-based (e.g., pTau217, NfL, GFAP, Aβ1-42/1-40)
- Structural MRI (temporal, frontal, and parietal regions)
- Optical coherence tomography (OCT) for retinal changes
- Analysis: Correlation with DECISION test battery performance and clinical indicators
- Recruitment Strategy Participants will be selected from previous cohorts (AmyClear and ActiGlia), allowing access to existing CSF, PET, and neuropsychological data. All participants will be re-consented and evaluated using standardized tools at baseline. If capacity is limited, a legal guardian or proxy will be engaged per ethical protocols.
- Inclusion/Exclusion Criteria
- Adults aged 50+
- Diagnosed or suspected cognitive impairment (per ICD-10 criteria)
- Able to provide consent or have a legal representative
- No severe sensory impairments interfering with testing
- Ethical Framework The study follows the Declaration of Helsinki and German civil law (BGB). All assessments are designed to be minimally invasive, with an emphasis on autonomy, transparency, and participant safety. Focus groups with medical professionals and interviews with patients will inform test development.
- Co-Design and Participatory Approach Patients and caregivers contribute to item design and language accessibility. Medical professionals help ensure clinical relevance. Legal advisors assess conformity with consent standards.
- Outcomes and Statistical Analysis
- Primary endpoint: Validity and reliability of the new tool compared to MacCAT-T
- Secondary endpoints: Biomarker correlations, subgroup analyses (e.g., dementia type, anosognosia presence)
- Analytical methods: Correlation, regression, factor analysis, ROC curves, AUC calculations
- Data Handling and Security Data will be pseudonymized and stored within the MeDICLMU infrastructure. Personal identifiers are kept separate and encrypted. Access is limited to the study team. Data usage will comply with GDPR.
- Timeline
- Study start: September 2025
- End of recruitment: March 2026
- Final assessments and analysis: March 2027
- Dissemination Results will be published in peer-reviewed journals and presented at international conferences. A clinical guideline for using the consent assessment tool will be developed.
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.
- Conditions
- Alzheimer Disease, Neurodegenerative Diseases
- Keywords
- Informed Consent, Biomarkers, Cognition Disorders
- Medical subject headings
- Alzheimer Disease, Neurodegenerative Diseases, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with AD spectrum for consent capacity and biomarker validation study | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 09/25 - 09/26
Secondary outcomes (1)
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.
Measured: 09/25 - 09/26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start2 Oct 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolin Kurz, Ludwig-Maximilians - University of Munich
- Investigators
- Carolin Isabella Kurz, M.D., Principal investigator, Department of Psychiatry and Psychotherapy, LMU hospitalPaulina Tegethoff, M.Sc., Principal investigator, Department of Psychiatry and Psychotherapy, LMU hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514520
- Sponsor's protocol ID
- LudwigsMaximilians
- Other IDs
- 25-0177
- Acronym
- DECISION
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Boudriot E, Gabriel V, Popovic D, Pingen P, Yakimov V, Papiol S, Roell L, Hasanaj G, Xu S, Moussiopoulou J, Priglinger S, Kern C, Schulte EC, Hasan A, Pogarell O, Falkai P, Schmitt A, Schworm B; CDP Working Group; Wagner E, Keeser D, Raabe FJ. Signature of Altered Retinal Microstructures and Electrophysiology in Schizophrenia Spectrum Disorders Is Associated With Disease Severity and Polygenic Risk. Biol Psychiatry. 2024 Nov 15;96(10):792-803. doi: 10.1016/j.biopsych.2024.04.014. Epub 2024 Apr 27.
PubMed 38679358Boyd JL. A validity study of the Hooper Visual Organization Test. J Consult Clin Psychol. 1981 Feb;49(1):15-9. doi: 10.1037//0022-006x.49.1.15. No abstract available.
PubMed 7217472Heyrani R, Sarabi-Jamab A, Grafman J, Asadi N, Soltani S, Mirfazeli FS, Almasi-Dooghaei M, Shariat SV, Jahanbakhshi A, Khoeini T, Joghataei MT. Limits on using the clock drawing test as a measure to evaluate patients with neurological disorders. BMC Neurol. 2022 Dec 31;22(1):509. doi: 10.1186/s12883-022-03035-z.
PubMed 36585622Moelter ST, Weintraub D, Mace L, Cary M, Sullo E, Xie SX, Karlawish J. Research consent capacity varies with executive function and memory in Parkinson's disease. Mov Disord. 2016 Mar;31(3):414-7. doi: 10.1002/mds.26469. Epub 2016 Feb 10.
PubMed 26861463Warner J, McCarney R, Griffin M, Hill K, Fisher P. Participation in dementia research: rates and correlates of capacity to give informed consent. J Med Ethics. 2008 Mar;34(3):167-70. doi: 10.1136/jme.2006.019786.
PubMed 18316457Parmigiani G, Del Casale A, Mandarelli G, Barchielli B, Kotzalidis GD, D'Antonio F, Di Vita A, de Lena C, Ferracuti S. Decisional capacity to consent to treatment and research in patients affected by Mild Cognitive Impairment. A systematic review and meta-analysis. Int Psychogeriatr. 2022 Jun;34(6):529-542. doi: 10.1017/S1041610220004056. Epub 2021 Feb 15.
PubMed 33583459Palmer BW, Harmell AL, Pinto LL, Dunn LB, Kim SY, Golshan S, Jeste DV. Determinants of Capacity to Consent to Research on Alzheimer's disease. Clin Gerontol. 2017;40(1):24-34. doi: 10.1080/07317115.2016.1197352. Epub 2016 Jun 7.
PubMed 28154452Rolfes V, Hinz U, Fangerau H, Vossberg D, Haupt M. [MacCAT-T between Claim and Practice - Challenges of Assessing Capacity for Consent in Dementia]. Fortschr Neurol Psychiatr. 2024 Oct;92(10):413-422. doi: 10.1055/a-2236-9338. Epub 2024 Mar 28. German.
PubMed 38547903
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline - DECISION
- ClinicalTrials.gov ID
- NCT07514520
- Acronym / sponsor ID
- DECISION / LudwigsMaximilians
- Conditions
- Alzheimer Disease, Neurodegenerative Diseases
- Keywords
- Informed Consent, Biomarkers, Cognition Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Develop a standardized, brief, and reusable tool to assess capacity to consent in individuals with neurocognitive disorders. Secondary Objectives:
- Validate the tool against established standards (e.g., MacCAT-T).
- Examine the relationship between cognitive domains (e.g., language, attention) and decision-making.
- Investigate correlations between neurodegenerative and vascular biomarkers and consent capacity.
- Study Design The DECISION study is structured as a two-phase, prospective cohort study with mixed-methods integration. Phase 1: Tool Development and Validation
- Sample: 100-150 participants (patients with varying dementia subtypes and healthy controls).
- Methodology:
- Comprehensive neuropsychological profiling
- Test item development from domains critical to decision-making (attention, executive function, language comprehension, risk assessment)
- Use of MacCAT-T and Clinical Dementia Rating (CDR) for validation
- Comparison of subjective and informant-reported measures (e.g., Cognitive Failures Questionnaire, Dysexecutive Questionnaire)
- Output: A modular test battery with a shortened, clinically usable version Phase 2: Neurobiological Correlates
- Objective: Identify biomarkers associated with impaired consent capacity
- Biomarkers:
- Blood-based (e.g., pTau217, NfL, GFAP, Aβ1-42/1-40)
- Structural MRI (temporal, frontal, and parietal regions)
- Optical coherence tomography (OCT) for retinal changes
- Analysis: Correlation with DECISION test battery performance and clinical indicators
- Recruitment Strategy Participants will be selected from previous cohorts (AmyClear and ActiGlia), allowing access to existing CSF, PET, and neuropsychological data. All participants will be re-consented and evaluated using standardized tools at baseline. If capacity is limited, a legal guardian or proxy will be engaged per ethical protocols.
- Inclusion/Exclusion Criteria
- Adults aged 50+
- Diagnosed or suspected cognitive impairment (per ICD-10 criteria)
- Able to provide consent or have a legal representative
- No severe sensory impairments interfering with testing
- Ethical Framework The study follows the Declaration of Helsinki and German civil law (BGB). All assessments are designed to be minimally invasive, with an emphasis on autonomy, transparency, and participant safety. Focus groups with medical professionals and interviews with patients will inform test development.
- Co-Design and Participatory Approach Patients and caregivers contribute to item design and language accessibility. Medical professionals help ensure clinical relevance. Legal advisors assess conformity with consent standards.
- Outcomes and Statistical Analysis
- Primary endpoint: Validity and reliability of the new tool compared to MacCAT-T
- Secondary endpoints: Biomarker correlations, subgroup analyses (e.g., dementia type, anosognosia presence)
- Analytical methods: Correlation, regression, factor analysis, ROC curves, AUC calculations
- Data Handling and Security Data will be pseudonymized and stored within the MeDICLMU infrastructure. Personal identifiers are kept separate and encrypted. Access is limited to the study team. Data usage will comply with GDPR.
- Timeline
- Study start: September 2025
- End of recruitment: March 2026
- Final assessments and analysis: March 2027
- Dissemination Results will be published in peer-reviewed journals and presented at international conferences. A clinical guideline for using the consent assessment tool will be developed.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with AD spectrum for consent capacity and biomarker validation study | – | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development and Validation of a Consent Capacity Assessment Tool in Neurocognitive Disorders
Time frame: 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.
1 secondary outcome
Correlation Between Consent Capacity and Neurobiological Markers
Time frame: 09/25 - 09/26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 38679358Boudriot E, Gabriel V, Popovic D, Pingen P, Yakimov V, Papiol S, Roell L, Hasanaj G, Xu S, Moussiopoulou J, Priglinger S, Kern C, Schulte EC, Hasan A, Pogarell O, Falkai P, Schmitt A, Schworm B; CDP Working Group; Wagner E, Keeser D, Raabe FJ. Signature of Altered Retinal Microstructures and Electrophysiology in Schizophrenia Spectrum Disorders Is Associated With Disease Severity and Polygenic Risk. Biol Psychiatry. 2024 Nov 15;96(10):792-803. doi: 10.1016/j.biopsych.2024.04.014. Epub 2024 Apr 27.
- Results publication: PubMed 7217472Boyd JL. A validity study of the Hooper Visual Organization Test. J Consult Clin Psychol. 1981 Feb;49(1):15-9. doi: 10.1037//0022-006x.49.1.15. No abstract available.
- Results publication: PubMed 36585622Heyrani R, Sarabi-Jamab A, Grafman J, Asadi N, Soltani S, Mirfazeli FS, Almasi-Dooghaei M, Shariat SV, Jahanbakhshi A, Khoeini T, Joghataei MT. Limits on using the clock drawing test as a measure to evaluate patients with neurological disorders. BMC Neurol. 2022 Dec 31;22(1):509. doi: 10.1186/s12883-022-03035-z.
- Results publication: PubMed 26861463Moelter ST, Weintraub D, Mace L, Cary M, Sullo E, Xie SX, Karlawish J. Research consent capacity varies with executive function and memory in Parkinson's disease. Mov Disord. 2016 Mar;31(3):414-7. doi: 10.1002/mds.26469. Epub 2016 Feb 10.
- Results publication: PubMed 18316457Warner J, McCarney R, Griffin M, Hill K, Fisher P. Participation in dementia research: rates and correlates of capacity to give informed consent. J Med Ethics. 2008 Mar;34(3):167-70. doi: 10.1136/jme.2006.019786.
- Results publication: PubMed 33583459Parmigiani G, Del Casale A, Mandarelli G, Barchielli B, Kotzalidis GD, D'Antonio F, Di Vita A, de Lena C, Ferracuti S. Decisional capacity to consent to treatment and research in patients affected by Mild Cognitive Impairment. A systematic review and meta-analysis. Int Psychogeriatr. 2022 Jun;34(6):529-542. doi: 10.1017/S1041610220004056. Epub 2021 Feb 15.
- Results publication: PubMed 28154452Palmer BW, Harmell AL, Pinto LL, Dunn LB, Kim SY, Golshan S, Jeste DV. Determinants of Capacity to Consent to Research on Alzheimer's disease. Clin Gerontol. 2017;40(1):24-34. doi: 10.1080/07317115.2016.1197352. Epub 2016 Jun 7.
- Results publication: PubMed 38547903Rolfes V, Hinz U, Fangerau H, Vossberg D, Haupt M. [MacCAT-T between Claim and Practice - Challenges of Assessing Capacity for Consent in Dementia]. Fortschr Neurol Psychiatr. 2024 Oct;92(10):413-422. doi: 10.1055/a-2236-9338. Epub 2024 Mar 28. German.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolin Isabella Kurz, M.D. principal investigator
Department of Psychiatry and Psychotherapy, LMU hospital
Paulina Tegethoff, M.Sc. principal investigator
Department of Psychiatry and Psychotherapy, LMU hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Neurodegenerative Diseases, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and Validation of a Consent Capacity Assessment Tool in Neurocognitive Disorders (time frame: 09/25 - 09/26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07514520, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.