This study will look at the ability of ST101 to treat symptoms in subjects with Essential Tremor. This study will also examine the safety and tolerability of the drug. This study is evaluating one dose level of ST101 versus placebo in a cross-over fashion. This means that all patients will receive both ST101 and placebo, but they will receive it in a random (by chance) order.

开始日期2011-04-01

申办/合作机构

Sonexa Therapeutics, Inc.

NCT00842673 / Completed临床2期

A Double-Blind Placebo-Controlled Preliminary Study of the Efficacy, Safety and Tolerability of ST101 Tablets in the Treatment of Alzheimer's Disease

This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease. This study also will examine the safety and tolerability of the drug. This study is evaluating 3 different dose levels of ST101 and placebo. Patients will have a 1 in 4 chance of getting placebo.

开始日期2009-02-01

申办/合作机构

Sonexa Therapeutics, Inc.

NCT00842816 / Completed临床2期

A Double-Blind Placebo-Controlled Preliminary Study of the Efficacy, Safety and Tolerability of ST101 Tablets in the Treatment of Alzheimer's Disease in Subjects Concurrently Receiving Donepezil (Aricept®)

This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease who currently receive 10 mg Aricept® (donepezil) per day. This study also will examine the safety and tolerability of the drug. This study is evaluating 3 different dose levels of ST101 and placebo. Patients will have a 1 in 4 chance of getting placebo. All eligible subjects will be provided with bottles of 10 mg Aricept (donepezil) during the study drug administration part of the study.

开始日期2009-02-01

申办/合作机构

Sonexa Therapeutics, Inc.

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项与 Sonexa Therapeutics, Inc. 相关的文献（医药）

2015-09-09·Journal of Alzheimer's Disease3区 · 医学

Effects of the Acetylcholine Release Agent ST101 with Donepezil in Alzheimer’s Disease: A Randomized Phase 2 Study

3区 · 医学

Article

作者: Oltersdorf, Tilman ; Weber, Eckard ; Rountree, Susan ; Finn, Barbara ; Gauthier, Serge ; LaPlante, Barbra

BACKGROUND AND OBJECTIVEST101, an acetylcholine release agent with efficacy in rodent memory and cognition models, was assessed for clinical safety and efficacy.METHODSA phase 2 double blind, placebo-controlled study enrolled 210 AD patients (MMSE 10-20) on 10 mg donepezil QD. Patients received ST101 (10, 60, or 120 mg QD) or placebo for 12 weeks. The primary endpoint was change in cognitive function measured by ADAS-cog in the modified Intent To Treat (MITT) population and the Per Protocol (PP) population.RESULTSMean ADAS-cog change favored ST101 over placebo in the MITT population (p = 0.0957, one-sided) and in the PP population (p = 0.0434, one-sided, ∼1.5 point drug-placebo difference) comparing all ST101 dose groups combined to placebo. Among secondary and exploratory outcome measures the ADCS-CGIC also showed a beneficial trend (p = 0.0294, one-sided). In a post-hoc analysis, the subgroup with more severe disease (MMSE 10-17) showed a dose response in the ADAS-cog with the greatest efficacy at 120 mg (p = 0.0067, one sided). No significant ST101-related safety concerns were identified.CONCLUSIONThe study supports the possibility that ST101, in patients receiving a stable dose of donepezil, may provide additional symptomatic benefit in moderate AD.

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