drugset / Trial / NCT01424436
Modulation of Abeta Levels by GSK933776 in Alzheimer's Disease Patient
Non-randomizedParallel-groupOpen-labelOther
Summary
Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment
Timeline
- Start
- 2010-05-19
- Primary completion
- 2011-12-08
- Completion
- 2011-12-08
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper Sample size was based on feasibility, and no formal statistical analyses were performed. PMID 24716469 ↗
Publications
- Andreasen N, Simeoni M, Ostlund H, Lisjo PI, Fladby T, Loercher AE, Byrne GJ, Murray F, Scott-Stevens PT, Wallin A, Zhang YY, Bronge LH, Zetterberg H, Nordberg AK, Yeo AJ, Khan SA, Hilpert J, Mistry PC. First administration of the Fc-attenuated anti-beta amyloid antibody GSK933776 to patients with mild Alzheimer's disease: a randomized, placebo-controlled study. PLoS One. 2015 Mar 19;10(3):e0098153. doi: 10.1371/journal.pone.0098153. eCollection 2015.
- Leyhe T, Andreasen N, Simeoni M, Reich A, von Arnim CA, Tong X, Yeo A, Khan S, Loercher A, Chalker M, Hottenstein C, Zetterberg H, Hilpert J, Mistry P. Modulation of beta-amyloid by a single dose of GSK933776 in patients with mild Alzheimer's disease: a phase I study. Alzheimers Res Ther. 2014 Apr 9;6(2):19. doi: 10.1186/alzrt249. eCollection 2014.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK933776 | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | GSK933776 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | GSK933776 | Monoclonal antibody | 6 mg/kg | Intravenous |