Autoimmune dementia
Conditions
Brief summary
Cognitive impairment: MoCA: change from baseline to 53 weeks. (dichotomized version of the change of the score ≥0 or <0).
Detailed description
MoCA: Evaluation of change in continuous score from baseline to week 13, 27 and 53, Neuropsychological tests: change from baseline to week 13 and 53, Quality of Life: change from baseline to week 13 and 53, Activities of Daily Living: change from baseline to week 13 and 53, Reduction of autoantibodies from baseline to week 13 and 53, Partial normalization of further laboratory parameters from baseline to week 53, Serum and cerebrospinal fluid analyses with cell count, cytology, protein, glucose, lactate and infection markers
Interventions
DRUGInjection solution according to Vyvgart 1000 mg s.c. without active substance Efgartigimod alfa.
Sponsors
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive impairment: MoCA: change from baseline to 53 weeks. (dichotomized version of the change of the score ≥0 or <0). | — |
Secondary
| Measure | Time frame |
|---|---|
| MoCA: Evaluation of change in continuous score from baseline to week 13, 27 and 53, Neuropsychological tests: change from baseline to week 13 and 53, Quality of Life: change from baseline to week 13 and 53, Activities of Daily Living: change from baseline to week 13 and 53, Reduction of autoantibodies from baseline to week 13 and 53, Partial normalization of further laboratory parameters from baseline to week 53, Serum and cerebrospinal fluid analyses with cell count, cytology, protein, glucose, lactate and infection markers | — |
Countries
Germany
Outcome results
None listed