Clinical trial NCT06621758: Communication Regarding Preclinical Dementia Diagnostic and Diagnostic Disclosure Among Patients with MCI and SCD
Official title: Communication Regarding Preclinical Dementia Diagnostic and Diagnostic Disclosure Among Patients with MCI and SCD
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Alzheimer Disease
Mild Cognitive Impairment (MCI)
Subjective Cognitive Decline (SCD)
Keywords: communication
biomarkers
counseling
diagnostic disclosure
MCI
SCD
Lead sponsor: Danish Dementia Research Centre
Sponsor class: NETWORK
Collaborators: name: Toulouse University Hospital, Department of Geriatric &amp; Internal Medicine, France
name: Universitair Ziekenhuis Brussel, Department of Neurology, Belgium
name: University Medical Centre Ljubljana, Department of Neurology, Slovenia
First posted: 2024-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

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

Primary outcomes:
measure: Important issues in communication
timeFrame: From enrollment to the second questionnaire after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: