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

NCT06621758 | Not Yet Recruiting DMC

• 2 other identifiers: F-24061891ERA PerMed JTC2021
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

communication; biomarkers; counseling; diagnostic disclosure; MCI; SCD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MCI

Individuals diagnosed with mild cognitive impairment (MCI)

Other: questionnaire

SCD

Individuals diagnosed with subjective cognitive decline (SCD)

Other: questionnaire

Interventions

questionnaire OTHER

Questionnaire regarding biomarker counseling and diagnostic disclosure

MCI; SCD

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Diagnosis of current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis)
• Current excessive alcohol intake or substance abuse
• Attended the diagnostic disclosure visit together with the individual diagnosed with SCD or MCI

Sponsors & Collaborators

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

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Communication

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Marie Bruun, MD, PhD

CONTACT

+45 35451910; marie.bruun@regionh.dk

Kristian S Frederiksen, MD, PhD

CONTACT

+45 35456922; kristian.steen.frederiksen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, clinical lector

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 1, 2024
• Study Start: October 15, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09