The primary objective of the original study was to assess the safety of semagacestat in Alzheimer's disease (AD) patients during 24 months of open-label treatment. Baseline for the efficacy measures is defined as the baseline for feeder studies LFAN (NCT00594568) and LFBC (NCT00762411). For all safety analyses (adverse events), baseline for patients will be week 0 of this study (LFBF). Preliminary results from LFAN and LFBC showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC and LFBF have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol. Very few participants from LFBC rolled over into LFBF (N = 9). Due to insufficient sample size, the data for LFBC participants who rolled into LFBF were not analyzed.
Manuscripts citing this dataset
- Development of semagacestat (LY450139), a functional γ-secretase inhibitor, for the treatment of Alzheimer's disease. 2009. DOI: https://doi.org/10.1517/14656560903044982
- REVIEW: γ‐Secretase Inhibitors for the Treatment of Alzheimer's Disease: The Current State. 2010. DOI: https://doi.org/10.1111/j.1755-5949.2010.00164.x
- A Phase 3 Trial of Semagacestat for Treatment of Alzheimer's Disease. 2013. DOI: 1056/NEJMoa1210951
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