臨床研究等提出・公開システム

Date of registration	Feb. 14, 2025
Last modified on	Feb. 14, 2025
Trial ID	jRCT1061240123

Scientific Title	Open study to examine the effects of brexpiprazole administered to Alzheimer's dementia patients with strong irritability on sleep
Public Title	Open study to examine the effects of brexpiprazole administered to Alzheimer's dementia patients with strong irritability on sleep

Contact for Scientific Queries	Name	ISHIKAWA Ichiro
	Affiliation	Kagawa university faculty of medicine
	Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa
	Telephone	+81-878912167
	E-mail	ishikawa.ichiro@kagawa-u.ac.jp
Contact for Public Queries	Name	ISHIKAWA Ichiro
	Affiliation	Kagawa university faculty of medicine
	Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa
	Telephone	+81-87-891-2167
	E-mail	ishikawa.ichiro@kagawa-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 14, 2025
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	The subjects were patients who were diagnosed with Alzheimer's type dementia and who required medication adjustments for hospitalization due to a strong focus, and who were admitted to the researcher's affiliated institution. Among the above patients, all of the following must also be met. 1) Diagnosis of Alzheimer's disease 2) Over 70 years old 3) Must have a score of 6 or higher excitement or irritability items before administration NPI. 4) The patient's physical condition is current and has not caused any major abnormality in the past year (malignant tumor, etc.)
	Exclusion Criteria	Those who fall under any of the following will be excluded. 1) Have a disease that affects sleep quality or daytime alertness 2) Have a physical illness that makes it difficult to complete the research 3) Meet diagnostic criteria for schizophrenia, mood disorder, delirium, etc. 4) Already taking other antipsychotics or benzodiazepine sleeping pills
	Age Minimum	70age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Alzheimer's disease
Intervention(s)		Oral medication, brexpiprazole
Health Condition(s) Code		D000544
Primary Outcome(s)		Changes in sleep structure due to PSG before and 4 weeks after brexpiprazole administration Total sleep time, sleep onset latency, mid-awakening time, sleep stage ratio, periodic leg movement index, apnea-hypopnea index.
Secondary Outcome(s)		NPI score, Athens Insomnia Scale

Name of Certified Review Board	Kagawa University Hospital Clinical Research Review Committee
Address	1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Kagawa
Telephone	+81-87-891-2011
E-Mail	kenkyu@kagawa-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 27, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none