Long-Term Safety and Efficacy of Donepezil in Patients with Severe Alzheimer’s Disease: Results from a 52-Week, Open-Label, Multicenter, Extension Study in Japan

2009 ◽  
Vol 27 (3) ◽  
pp. 232-239 ◽  
Author(s):  
Akira Homma ◽  
Yukimichi Imai ◽  
Hisao Tago ◽  
Takashi Asada ◽  
Masahiro Shigeta ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Extension Study ◽  
Open Label ◽  
Safety And Efficacy

scholarly journals Long-Term Follow Up of Patients with Mild-to-Moderate Alzheimer’s Disease Treated with Bapineuzumab in a Phase III, Open-Label, Extension Study

2018 ◽  
Vol 64 (3) ◽  
pp. 689-707 ◽  
Author(s):  
Stephen P. Salloway ◽  
Reisa Sperling ◽  
Nick C. Fox ◽  
Marwan N. Sabbagh ◽  
Lawrence S. Honig ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Phase Iii ◽  
Extension Study ◽  
Open Label ◽  
Open Label Extension ◽  
Long Term Follow Up

Long-Term Safety and Efficacy of Bapineuzumab in Patients with Mild-to-Moderate Alzheimer’s Disease: A Phase 2, Open-Label Extension Study

2018 ◽  
Vol 15 (13) ◽  
pp. 1231-1243 ◽  
Author(s):  
Stephen Salloway ◽  
Gad A. Marshall ◽  
Ming Lu ◽  
H. Robert Brashear
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Functional Decline ◽  
Phase 2 ◽  
Open Label ◽  
Safety And Efficacy ◽  
Delayed Treatment ◽  
Significant Difference ◽  
Open Label Extension

Background: Bapineuzumab is a humanized anti-amyloid-beta (Aβ) monoclonal antibody directed at lowering the cerebral Aβ deposit in Alzheimer’s disease (AD). Objective: This phase 2, open-label extension (OLE) study evaluated long-term safety and efficacy of bapineuzumab in patients with the mild-to-moderate AD. Methods: Patients (58-78 years) who completed either of two randomized, placebo-controlled, doubleblind studies (subcutaneous [SC] single-dose-escalation, or intravenous (IV) multiple-ascending-dose)) entered the OLE. Three groups were assessed: bapineuzumab or placebo SC, and bapineuzumab (IV) in OLE (bapi SC/bapi IV); bapineuzumab (IV) in Study 201 and OLE (bapi/bapi); and placebo in Study 201 and bapineuzumab IV in OLE (placebo/bapi). Results: Of 194 patients enrolled, 158 withdrew from OLE; primarily due to withdrawal by subject (n=85) and AE (n=30). Mean (SD) bapineuzumab exposure was 2.9 (1.90) years. There were no significant differences for efficacy endpoints (AD Assessment Scale–cognitive subscale [ADAS-Cog], Disability Assessment for Dementia [DAD] and MMSE scores) between the bapi/bapi and placebo/bapi groups. Most patients (94.8%, 184/194) reported ≥1 treatment-emergent adverse events (TEAEs) in OLE. Amyloid-related imaging abnormalities with effusion or edema (ARIA-E) occurred in 22 (11.3%) patients. The most common TEAEs (>20% patients) were fall, agitation and urinary tract infection with similar incidences between bapi/bapi and placebo/bapi groups. Conclusion: No significant difference was seen in cognitive and functional decline between early and delayed treatment groups. No new safety concerns emerged. ARIA-E incidence was higher in patients first exposed to bapineuzumab in OLE versus previously exposed. No clear pattern of etiology contributed to death events.

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