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

NCT ID: NCT06621758

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2026-08-01

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MCI

Individuals diagnosed with mild cognitive impairment (MCI)

questionnaire

Intervention Type: OTHER

Questionnaire regarding biomarker counseling and diagnostic disclosure

SCD

Individuals diagnosed with subjective cognitive decline (SCD)

questionnaire

Intervention Type: OTHER

Questionnaire regarding biomarker counseling and diagnostic disclosure

Interventions

questionnaire

Questionnaire regarding biomarker counseling and diagnostic disclosure

Intervention Type: OTHER

Eligibility Criteria

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

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

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Toulouse University Hospital, Department of Geriatric & Internal Medicine, France

UNKNOWN

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel, Department of Neurology, Belgium

UNKNOWN

Sponsor Role: collaborator

University Medical Centre Ljubljana, Department of Neurology, Slovenia

UNKNOWN

Sponsor Role: collaborator

Danish Dementia Research Centre

NETWORK

Sponsor Role: lead

Responsible Party

Kristian Steen Frederiksen, MD

MD, PhD, clinical lector

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Marie Bruun, MD, PhD

Role: CONTACT

marie.bruun@regionh.dk

+45 35451910

Kristian S Frederiksen, MD, PhD

Role: CONTACT

kristian.steen.frederiksen@regionh.dk

+45 35456922

Other Identifiers

ERA PerMed JTC2021

Identifier Type: OTHER

Identifier Source: secondary_id

F-24061891

Identifier Type: -

Identifier Source: org_study_id