Table 3.
Potential use of cerebrospinal fluid biomarkers in clinical trials.
Application | Explanation | Time point for use |
---|---|---|
Clinical diagnosis | CSF biomarkers may be valuable in clinical trials on patients with early AD or MCI, to enrich the patient cohort with pure AD cases | Baseline evaluation of cases eligible for the trial |
Stratification of cases | Cases with biomarker evidence of a disturbance in Aβ metabolism or deposition may show a better effect of anti-Aβ disease-modifying drug candidates | Baseline evaluation of cases eligible for the trial |
Safety monitoring | Some cases treated with anti-Aβ drug candidates, such as Aβ immunotherapy, may have adverse events such as meningoencephalitis or vasogenic edema. | Baseline evaluation of cases and if a possible adverse event occurs |
Theragnostics | CSF biomarkers may provide information that the drug has an effect on the biochemistry and pathogenic processes directly in patients with AD | Baseline evaluation and at time-points during the trial, including the last week of the trial |