Alzheimer's Disease Clinical Trial
Official title:
Open-Label Extension for Alzheimer's Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)
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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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