臨床研究等提出・公開システム

Date of registration	Dec. 17, 2021
Last modified on	Mar. 31, 2025
Trial ID	jRCT2031210496

Scientific Title	A Phase 3 Study of TW-4752N, Randomised, Double-blind, Parallel Group Trial in Patients with mild and moderate Alzheimer's disease
Public Title	A Phase 3 Study of TW-4752N in Patients with mild and moderate Alzheimer's disease

Contact for Scientific Queries	Name	Ogawa Koji
	Affiliation	TOWA PHARMACEUTICAL CO.,LTD.
	Address	2-5-15, Hiyoshi-cho, Moriguchi, Osaka
	Telephone	+81-6-6991-5515
	E-mail	rinsho@towayakuhin.co.jp
Contact for Public Queries	Name	Department Development Crinical
	Affiliation	TOWA PHARMACEUTICAL CO.,LTD.
	Address	2-5-15, Hiyoshi-cho, Moriguchi, Osaka
	Telephone	+81-6-6991-5515
	E-mail	rinsho@towayakuhin.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 17, 2021
Actual date of first enrollment		Dec. 20, 2021
Target sample size		340
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Persons who meet the diagnostic criteria for Alzheimer's disease according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders / Diseases (DSM-5) . (2) With a revised Hachinski cerebral ischemia score of 4 points or less. (3) With a baseline ABC dementia scale of 71 to 100. (4) With a baseline MMSE-J score of 10 to 26 points. (5) With a baseline ADAS-Jcog score of 12 to 43 points. (6) Those who have findings consistent with the diagnosis of Alzheimer's disease by imaging examination (CT or MRI) within 24 months before the observation period.
	Exclusion Criteria	(1) Persons with central nervous system diseases or systemic diseases that affect cognitive function or cognitive function evaluation other than Alzheimer's disease (2) Those who are diagnosed as having abnormal values of serum vitamin B12 or folic acid and affecting cognitive function at the time of screening. (3) Those who are diagnosed as having abnormal values of thyroid stimulating hormone (TSH) or free thyroxine (FT4) and affecting cognitive function at the time of screening. (4) Those who plan to enter a long-term care facility during the observation period and the double-blind period.
	Age Minimum	50age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Mild and moderate Alzheimer's disease
Intervention(s)		(1) Double-blind period The investigational products are administered as follows according to assignment. -TW-4752N group: Apply TW-4752N once every 3 days or 4 days. -Rivastigmine group: Apply one rivastigmine tape once a day. (2) Open-label period Apply TW-4752N once every 3 days or 4 days.
Primary Outcome(s)		Efficacy:Change from baseline at 24 weeks of double-blind in ADAS-Jcog

Primary Sponsor	TOWA PHARMACEUTICAL CO.,LTD.

Name of Certified Review Board	Tokushukai Group Institutional Review Board
Address	1-8-7,Koji-machi,Chiyoda-ku, Tokyo
Telephone	+81-3-3263-4801
E-Mail	irb@mirai-iryo.com
Approval Status	Approval
Date of approval	July. 20, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	Mar. 31, 2025	(this page)	Changes
4	Dec. 26, 2024	Detail	Changes
3	Aug. 18, 2023	Detail	Changes
2	April. 02, 2023	Detail	Changes
1	Dec. 17, 2021	Detail

List of change history