Long-term safety and efficacy of TK-023 in Patients with Severe Dementia of the Alzheimer's Type

TEIKOKU SEIYAKU Co., LTD.1 个研究点目标入组 70 人开始时间: 待定最近更新: 2022年4月4日

试验速览

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•Diagnostic evidence of probable dementia of the Alzheimer's Type consistent with the Diagnostic and Statistical Manual for Mental Disorders-version V (DSM-V)
•Mini-Mental State Examination (MMSE) score of 1 to 12 at Baseline
•ABC dementia scale < 85 and > 13 at Baseline
•Stable donepezil dose of 10 mg, taken as a single, daily dose for >= 3 months prior to the Screening Visit
•Evidence consistent with Alzheimer's Type on any cranial image (CT or MRI) obtained within 24 months prior to the Screening Visit
•Subjects who have a caregiver
•Subjects who have been on a daily dose of donepezil hydrochloride 10 mg (any dosage form is applicable) for at least 3 months

•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
•Subjects unable to take donepezil hydrochloride 10 mg tablet
•Subjects with history of TK-023 administration

发起方

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