Alzheimer's Disease (AD)
Conditions
Brief summary
The goal of this study is to determine how blood biomarker tests (ptau217 and ptau217/Aβ42) performed in primary care influence the patient trajectory in individuals with cognitive concerns. Participants will provide a blood sample for biomarker testing and undergo clinical assessments as part of diagnostic evaluation.
Interventions
DIAGNOSTIC_TESTptau217
Quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients between 55 and 85 years old who consult their PCP due to concerns about their cognitive status.
Exclusion criteria
* Comorbidities that would interfere with study cooperation or interpretability of study results (for instance substance abuse or cardiac, renal or hepatic failure). * Concomitant medications that would interfere with cognitive assessments. * A prior diagnosis of AD and related disorders or other neurodegenerative disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in referral decision and working diagnosis | 2 years | Change in working diagnosis and referral decision (n = 240): The % of cases where a change occurs will be calculated from the contingency matrix. |
| Cognitive decline | 4 years | Positive (PPV) and negative (NPV) predictive value, the positive (LR+) and negative (LR-) likelihood ratio for predicting cognitive decline in the subsequent four years. |
Countries
Belgium
Outcome results
None listed