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

Study acronym: DECISION
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 16, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv2
  2. Study First Submitted
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.
Trial Details
NCT Number NCT07514520
Lead Sponsor Ludwig-Maximilians - University of Munich
Conditions
(from sponsor)		 Alzheimer Disease, Neurodegenerative Diseases
Related terms Alzheimer Disease, Cognition Disorders, Neurodegenerative Diseases
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov