Table 1 Challenges for implementing diagnostic and predictive biomarkers for early diagnosis, therapy, and prevention of Alzheimer’s disease
From: Diagnostic and progression biomarkers in cerebrospinal fluid of Alzheimer’s disease patients
Analytical and logistic challenges | Clinical challenges |
|---|---|
Collection of CSF, once or repeatedly, is invasive | Life-long therapy of AD may be necessary |
Test must demonstrate excellent analytical sensitivity and specificity | Side effects of pharmacological or other interventions should be minimal and not life-threatening |
Test cost should be acceptable to society | Tests must display excellent clinical sensitivity and specificity, along with high positive and negative predictive value. False positive and false negative results should be minimal, and a confirmatory test is necessary to resolve ambiguous results |
It may be challenging to derive reliable reference ranges for the biomarkers of interest due to difficulty in finding true non-diseased individuals and including patients with prodromal and asymptomatic disease. Reference ranges may need to be derived for various age groups, since the identified biomarkers change non-linearly and non-unidirectionally over time. Reference ranges may be highly wide due to inter-individual variation |