Decision-making, Ethical Consent, and Interactive Dialogue in Ongoing Neurocognitive Decline - DECISION

NCT07514520 | Active Not Recruiting

• 2 other identifiers: LudwigsMaximilians25-0177
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer Disease; Neurodegenerative Diseases

Keywords

Informed Consent; Biomarkers; Cognition Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  09/25 - 09/26

Secondary Outcomes (1)

• Correlation Between Consent Capacity and Neurobiological Markers

  09/25 - 09/26

Study Arms (1)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, LMU Hospital

Munich, Bavaria, 80336, Germany

Location

Related Publications (8)

• 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.

  PMID: 38679358 RESULT

• Boyd 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.

  PMID: 7217472 RESULT

• Heyrani 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.

  PMID: 36585622 RESULT

• Moelter 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.

  PMID: 26861463 RESULT

• Warner 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.

  PMID: 18316457 RESULT

• Parmigiani 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.

  PMID: 33583459 RESULT

• Palmer 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.

  PMID: 28154452 RESULT

• Rolfes 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.

  PMID: 38547903 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study will retain a range of biospecimens for the purpose of biomarker analysis related to neurodegeneration and vascular pathology. Specifically, the following types of samples will be collected and stored: * Plasma samples for the quantification of established and exploratory biomarkers, including but not limited to: * Amyloid-beta (Aβ1-42/1-40) * Phosphorylated tau (pTau217) * Neurofilament light chain (NfL) * Glial fibrillary acidic protein (GFAP) * Platelet-derived growth factor (PDGF), fibrinogen, pentraxin, and vascular endothelial growth factor (VEGF) * Serum samples for routine clinical parameters and exclusion diagnostics, including vitamin B12, folate ++++Cerebrospinal fluid (CSF) samples will not be newly obtained, but pre-existing samples from previous studies (AmyClear). +++++

MeSH Terms

Conditions

Alzheimer Disease; Neurodegenerative Diseases; Cognition Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders

Study Officials

• Carolin Isabella Kurz, M.D.

  Department of Psychiatry and Psychotherapy, LMU hospital

  PRINCIPAL INVESTIGATOR

• Paulina Tegethoff, M.Sc.

  Department of Psychiatry and Psychotherapy, LMU hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Carolin Kurz & Paulina Tegethoff M.Sc.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: April 7, 2026
• Study Start: October 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)