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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease; Subjective Cognitive Decline (SCD)
• Intervention / Treatment: Other: questionnaire

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Marie Bruun, MD, PhD; Phone Number: +45 35451910; Email: marie.bruun@regionh.dk
• Study Contact Backup: Name: Kristian S Frederiksen, MD, PhD; Phone Number: +45 35456922; Email: kristian.steen.frederiksen@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals 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.

Description

Inclusion Criteria:

• Diagnosed with SCD or MCI
• Lumbar puncture performed during the diagnostic process
• Age at or below 80 years
• MMSE at or above 24

Exclusion Criteria:

• Diagnosis of current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis)
• Current excessive alcohol intake or substance abuse

Inclusion criteria for the co-participant:

• Attended the diagnostic disclosure visit together with the individual diagnosed with SCD or MCI

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MCI; Individuals diagnosed with mild cognitive impairment (MCI)	Other: questionnaire; Questionnaire regarding biomarker counseling and diagnostic disclosure
SCD; Individuals diagnosed with subjective cognitive decline (SCD)	Other: questionnaire; Questionnaire regarding biomarker counseling and diagnostic disclosure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Important issues in communication	Rating of which issues are important for persons with SCD or MCI and their co-participant in the pre-diagnostic counseling and diagnostic disclosure communication.	From enrollment to the second questionnaire after 6 weeks

Collaborators and Investigators

• Sponsor: Danish Dementia Research Centre
• Collaborators: Toulouse University Hospital, Department of Geriatric & Internal Medicine, France; Universitair Ziekenhuis Brussel, Department of Neurology, Belgium; University Medical Centre Ljubljana, Department of Neurology, Slovenia

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: biomarkers; communication; counseling; MCI; SCD; diagnostic disclosure
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Dementia; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: F-24061891; ERA PerMed JTC2021 (Other Identifier: European Commission)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No