NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Alzheimer's disease
Date of first enrollment	14/02/2025
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	Oral medication, brexpiprazole

Outcome(s)

Primary Outcome	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	NPI score, Athens Insomnia Scale

Key inclusion & exclusion criteria

Age minimum	>= 70age old
Age maximum	Not applicable
Gender	Both
Include 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.)
Exclude 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