![]() ![]() įree-radical-induced oxidative stress is considered to be one of multiple factors contributing to AD pathogenesis, in part due to upregulation of the enzyme monoamine oxidase B (MAO-B) in astrocytes. Behavioral and neuropsychiatric symptoms (NPS), such as depression, agitation, aggression, apathy, delusions, and hallucinations, are also part of the disease, and can worsen over time, significantly contributing to disease burden. ![]() Post hoc analyses suggested potential effect on neuropsychiatric symptoms and functioning in more behaviorally impaired study population at baseline.Īlzheimer’s disease (AD) is characterized by a progressive loss of cognitive function and deterioration of the performance of activities of daily living. The study missed its primary and secondary endpoints. A post hoc subgroup analysis revealed greater treatment effects on behavior and functioning in patients with more severe baseline behavioral symptoms (above the median).Ĭonclusions: This study showed that sembragiline was well-tolerated in patients with moderate AD. A treatment effect in neuropsychiatric symptoms (as assessed by the difference between sembragiline and placebo on BEHAVE-AD-FW) was also seen at Week 52 only: – 2.80 ( p = 0.014 1 mg) and – 2.64 ( p = 0.019 5 mg), respectively. Relative to placebo at Week 52 (but not at prior assessment times), the 1 mg and 5 mg sembragiline groups showed differences in ADCS-ADL of 2.64 ( p = 0.051) and 1.89 ( p = 0.160), respectively. At Week 52, the difference between sembragiline and placebo in ADAS-Cog11 change from baseline was – 0.15 ( p = 0.865) and 0.90 ( p = 0.312) for 1 and 5 mg groups, respectively. ![]() The primary endpoint, change from baseline in ADAS-Cog11, was not met. Results: No differences between treated groups and placebo in adverse events or in study completion. Methods: In this Phase II study (NCT01677754), 542 patients with moderate dementia (MMSE 13–20) on background acetylcholinesterase inhibitors with/without memantine were randomized (1:1:1) to sembragiline 1 mg, 5 mg, or placebo once daily orally for 52 weeks. Objective: To evaluate the safety, tolerability, and efficacy of sembragiline in patients with moderate AD. Post hoc analyses suggested potential effect on neuropsychiatric symptoms and functioning in more behaviorally impaired study population at baseline.īackground: Sembragiline is a potent, selective, long-acting, and reversible MAO-B inhibitor developed as a potential treatment for Alzheimer’s disease (AD). A post hoc subgroup analysis revealed greater treatment effects on behavior and functioning in patients with more severe baseline behavioral symptoms (above the median).ConclusionsThis study showed that sembragiline was well-tolerated in patients with moderate AD. A treatment effect in neuropsychiatric symptoms (as assessed by the difference between sembragiline and placebo on BEHAVE-AD-FW) was also seen at Week 52 only: - 2.80 (p = 0.014 1 mg) and - 2.64 (p = 0.019 5 mg), respectively. Relative to placebo at Week 52 (but not at prior assessment times), the 1 mg and 5 mg sembragiline groups showed differences in ADCS-ADL of 2.64 (p = 0.051) and 1.89 (p = 0.160), respectively. At Week 52, the difference between sembragiline and placebo in ADAS-Cog11 change from baseline was - 0.15 (p = 0.865) and 0.90 (p = 0.312) for 1 and 5 mg groups, respectively. BackgroundSembragiline is a potent, selective, long-acting, and reversible MAO-B inhibitor developed as a potential treatment for Alzheimer's disease (AD).ObjectiveTo evaluate the safety, tolerability, and efficacy of sembragiline in patients with moderate AD.MethodsIn this Phase II study (NCT01677754), 542 patients with moderate dementia (MMSE 13-20) on background acetylcholinesterase inhibitors with/without memantine were randomized (1:1:1) to sembragiline 1 mg, 5 mg, or placebo once daily orally for 52 weeks.ResultsNo differences between treated groups and placebo in adverse events or in study completion. ![]()
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