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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1061240123
Enrollment
20
Registered
2025-02-14
Start date
2025-02-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimers disease

Interventions

Oral medication, brexpiprazole

Sponsors

ISHIKAWA Ichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
NPI score, Athens Insomnia Scale

Contacts

Public ContactIchiro ISHIKAWA

Kagawa university faculty of medicine

ishikawa.ichiro@kagawa-u.ac.jp+81-87-891-2167

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026