臨床研究等提出・公開システム

Date of registration	Mar. 26, 2019
Last modified on	April. 04, 2022
Trial ID	jRCT2080224612

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

Completion Date or Terminated date	Aug. 06, 2021
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	TEIKOKU SEIYAKU Co., LTD.
	Address	TOKYO OFFICE 6-6 Nihonbashi-kobunacho, Chuo-ku, Tokyo 103-0024 Japan
	Phone Number	+81-3-6264-9123
	E-mail Address	rinsho@teiyaku.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	TEIKOKU SEIYAKU Co., LTD.
	Address	TOKYO OFFICE 6-6 Nihonbashi-kobunacho, Chuo-ku, Tokyo 103-0024 Japan
	Phone Number	+81-3-6264-9123
	E-mail Address	rinsho@teiyaku.co.jp

Recruitment Status	completed

Date of First Enrolment		Mar. 31, 2019
Target Sample Size		70
Study Type		Interventional
Study Design	Study Design	Multicenter, Open-Label, Uncontrolled, Long-term Study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1. Diagnostic evidence of probable dementia of the Alzheimer's Type consistent with the Diagnostic and Statistical Manual for Mental Disorders-version V (DSM-V) 2. Mini-Mental State Examination (MMSE) score of 1 to 12 at Baseline 3. ABC dementia scale < 85 and > 13 at Baseline 4. Stable donepezil dose of 10 mg, taken as a single, daily dose for >= 3 months prior to the Screening Visit 5. Evidence consistent with Alzheimer's Type on any cranial image (CT or MRI) obtained within 24 months prior to the Screening Visit 6. Outpatient 7. Subjects who have a caregiver 8. Subjects who have been on a daily dose of donepezil hydrochloride 10 mg (any dosage form is applicable) for at least 3 months
	Exclusion Criteria	1. Subjects with dementia other than Alzheimer's type 2. Subjects with a cause of Dementia which is supported by any laboratory tests 3. Subjects with an active skin lesion/disorder that may affect adhesion and skin symptom assessment on the application site. 4. Subjects with history of photosensitivity 5. Subjects with allergy to component of donepezil hydrochloride (including excipients) or piperidine derivative. 6. Subjects with allergy to external preparation 7. Subjects unable to take donepezil hydrochloride 10 mg tablet 8. Subjects with history of TK-023 administration
	Minimum Age	50age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Dementia of the Alzheimer's type
Intervention(s)		investigational material(s) Generic name etc : Donepezil INN of investigational material : Donepezil Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for Investigational material : Once daily (55 mg) control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety Adverse events, Clinical laboratory values, Pregnancy tests, Vital signs, Body weight, 12-lead ECGs
Secondary Outcome		efficacy 1. Changes from baseline to weeks 12, 24, 52 in MMSE score 2. Changes from baseline to weeks 12, 24, 52 in ABC dementia scale and TDD (three dimensional distance)

Primary Sponsor	TEIKOKU SEIYAKU Co., LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	IRB of Sugiura Clinic
Address of IRB	4-4-16 Honcho, Kawaguchi-shi, Saitama-ken 332-0012 Japan
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Mar. 20, 2019

Secondary ID No.	JapicCTI-194683
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
6	April. 04, 2022	(this page)	Changes
5	Mar. 15, 2021	Detail	Changes
4	Dec. 24, 2020	Detail	Changes
3	Oct. 02, 2020	Detail	Changes
2	Mar. 10, 2020	Detail	Changes
1	Mar. 27, 2019	Detail

List of change history