A Phase III Study of TK-023 in Patients with Mild to Moderate Dementia of the Alzheimer's Type

TEIKOKU SEIYAKU Co., LTD.1 个研究点目标入组 328 人开始时间: 待定最近更新: 2022年10月26日

试验速览

暂无简介。

研究类型: Interventional
干预模型: Multicenter, Randomized, Double-Blind, Double-Dummy, Open-Label Study, Parallel-Group, Non-inferiority Study
主要目的: Treatment Purpose

•Diagnostic evidence of probable dementia of the Alzheimer's Type consistent with the Diagnostic and Statistical Manual for Mental Disorders-version V (DSM-V) at Screening
•Hachinski Ischemic Score < 4 at Screening
•ABC dementia scale < 100 and > 71 at Baseline
•Mini-Mental State Examination (MMSE) score of 10 to 26 at Baseline
•ADAS-Jcog score > 15 at Baseline
•Subjects who have a caregiver

•Subjects with dementia other than Alzheimer's type
•Subjects with a cause of Dementia which is supported by any laboratory tests
•Subjects with an active skin lesion/disorder that may affect adhesion and skin symptom assessment on the application site
•Subjects with history of photosensitivity
•Subjects with allergy to component of donepezil hydrochloride (including excipients) or piperidine derivative
•Subjects with allergy to external preparation

efficacy confirmatory ADAS-Jcog score and changes from baseline at 24 weeks of double-blind period

ADAS-Jcog score and changes from baseline(4-12 weeks)
ADL assessment: DAD score and changes from baseline(4-24 weeks)
Clinical global impression of change rating: ABC dementia scale and the changes from baseline(4-24 weeks)
ADAS-Jcog score, the changes from baseline/24th week(28-52 weeks)
Clinical global impression of change rating: ABC dementia scale and the changes from baseline/24th week(28-52 weeks)

发起方

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