NCT06621758

Communication Regarding Preclinical Dementia Diagnostic and Diagnostic Disclosure Among Patients with MCI and SCD

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Danish Dementia Research Centre · Network
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study investigate what information individuals with SCD or MCI and their co-participant would like to receive during pre-diagnostic counseling and diagnostic disclosure, and how this information should be conveyed.

Detailed description

Improved diagnostic work-up and the introduction of disease-modifying treatment have led to a shift towards earlier diagnosis. However, there are a need for better understanding of how best to communicate about biomarker use, assessment, and results in individuals with subjective cognitive decline (SCD) and mild cognitive impairment (MCI). Objective: The overarching objective of this study is: To understand what information individuals with SCD or MCI and their co-participant would like to receive during pre-diagnostic counseling and diagnostic disclosure, and how this information should be conveyed. Methods: a prospective survey study Persons diagnosed with SCD or MCI and co-participants will be recruited consecutively from the memory clinic, Copenhagen University Hospital - Rigshospitalet (Denmark), Toulouse University Hospital, (France), University Medical Centre Ljubljana (Slovenia) and Universitair Ziekenhuis Brussel (Belgium) Approximately 30 persons and respective co-participants will be included from each hospital over a period of 12 months. Each participating person and co-participant will be asked to complete a very brief questionnaire immediately after disclosure of the diagnosis, and another questionnaire 2-6 weeks after the disclosure visit.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment (MCI)
• Subjective Cognitive Decline (SCD)

Interventions

Type	Name	Description
OTHER	questionnaire	Questionnaire regarding biomarker counseling and diagnostic disclosure

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-02-01
• Completion: 2026-08-01
• First posted: 2024-10-01
• Last updated: 2024-10-01