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

Danish Dementia Research Centre

Status: Not yet enrolling

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

Treatments: Other: questionnaire

Study type: Observational

Funder types: NETWORK; Other

Identifiers

NCT06621758

F-24061891

ERA PerMed JTC2021 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

MCI

Description:

Individuals diagnosed with mild cognitive impairment (MCI)

Treatment:

Other: questionnaire

SCD

Description:

Individuals diagnosed with subjective cognitive decline (SCD)

Treatment:

Other: questionnaire