Table 1 Visit schedule with assessments
Period/Visit name | Screening | Baseline 1 | Baseline 2 &Randomization | Treatment period: Placebo vs Verum1 | Follow-Up | Treatment period: Verum2 | Follow-Up | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
S (V1) | B1 | B2 (V2) | SV (V3) | SV (V4) | SV (V5) | FU1 (V6) | SV (V7) | SV (V8) | SV (V9) | FU2 (V10) | FU3 (V11) | |
Trial days | − 28 to 0 | − 14 to 0 | 2 | 14 | 28 | 56 | 86 | 98 | 112 | 140 | 365 | |
Time windows | ± 3 days | ± 30 days | ||||||||||
Outpatient visit | • | • | • | • | • | • | • | • | • | • | ||
Informed consent | • | |||||||||||
Inclusion and exclusion criteria | • | |||||||||||
Randomization | • | |||||||||||
Discharge from trial | • | |||||||||||
History | ||||||||||||
Demographic data | • | • | ||||||||||
Medical history | • | |||||||||||
Diagnostic assessments | ||||||||||||
Structural cMRI | • | |||||||||||
Diagnostic blood sample3 | • | • | • | |||||||||
Lumbar puncture4 | • | |||||||||||
Safety assessments | ||||||||||||
Neurological and general physical examination | • | • | • | |||||||||
Pregnancy test in female patients | • | • | • | • | • | |||||||
Blood sample A5 | • | • | • | • | • | • | ||||||
Blood sample B6 | • | • | • | |||||||||
Clinical and sonographic exclusion of thrombosis | • | • | ||||||||||
AE questioning | • | • | • | • | • | • | • | • | • | |||
Concomitant medication | • | • | • | • | • | • | • | • | • | • | ||
Outcome assessments | ||||||||||||
Patient reported symptoms | • | • | • | • | ||||||||
Multifactorial Memory Questionnaire | • | • | • | • | ||||||||
Short form 36 Health survey | • | • | • | • | ||||||||
Fatigue severity scale | • | • | • | • | ||||||||
Chalder fatigue scale | • | • | • | • | ||||||||
Beck depression inventory-II | • | • | • | |||||||||
Montreal cognitive assessment | • | • | • | |||||||||
PROMIS 29 | • | • | • | |||||||||
PROMIS Cognitive Function Short form 4a | • | • | • | |||||||||
Verbal learning and memory test | • | • | • | |||||||||
Brief Visuospatial memory test—revised | • | • | • | |||||||||
WAIS-IV | • | • | • | |||||||||
Test battery for attention performance | • | • | • | |||||||||
Trail-making-test A and B | • | • | • | |||||||||
Regensburger Wortflüssigkeits-test | • | • | • | |||||||||
Symbol digit modalities test | • | • | ||||||||||
Wortschatztest | • | |||||||||||
LPS | • | |||||||||||
Assessment of self-experienced exposure to IMP | • | |||||||||||
Enrolment in diagnostic and biomarker platform study in a subgroup | • | • | ||||||||||