EVALUATE SAFETY & TOLERABILITY OF DMP 543 FOR ALZHEIMERS PATIENTS

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• 批准号: 6264699
• 负责人: CHRISTOPHER H VAN DYCK
• 金额: $ 3.45万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264699
• 关键词: Alzheimer's disease; acetylcholine; brain disorder chemotherapy; clinical research; dosage; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; neurotransmitter agonist

The purpose of the study is to determine the safety of DMP 543 during multiple dosing in patients with Alzheimer's disease. Identification of a minimum intolerable dose as defined by adverse experiences will be subject to the limitation of individual peak plasma concentrations, not to exceed 5.0 ng/ml during dosing. The study will be a single-site, placebo-controlled escalating multiple dose, inpatient and outpatient study. Yale will be the only study site. Study was terminated in November 1998 by Industry Sponsor.

该研究的目的是确定阿尔茨海默病患者多次给药期间的安全性。 根据不良事件定义的最小不可耐受剂量的确定将受到个体血浆峰浓度的限制，给药期间不得超过5.0 ng/ml。 本研究将是一项单中心、安慰剂对照、递增多次给药、住院和门诊研究。 耶鲁将是唯一的研究地点。 研究于1998年11月由行业申办方终止。