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A multicenter study to elucidate the biological basis of behavioral and psychological symptoms of dementia (BPSD) using prospectively collected data of neuroimaging and blood biomarkers and to establish a method to predict the effects of non-pharmacological treatment for BPSD

A multicenter study to elucidate the biological basis of behavioral and psychological symptoms of dementia (BPSD) using prospectively collected data of neuroimaging and blood biomarkers and to establish a method to predict the effects of non-pharmacological treatment for BPSD - J-BIRD-PNB Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000047522
Enrollment
150
Registered
2022-04-19
Start date
2022-04-18
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

Alzheimer&#39

Interventions

None listed

Sponsors

Japan Agency for Medical Research and Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients who meet the diagnostic criteria for AD or DLB 2) Age at enrollment: between 50 and 90 years old 3) A total score of 10 or more on the Neuropsychiatric Inventory (NPI) excluding eating behavior abnormalities, and a score of 2 or more on any of the following sub-items: delusions, hallucinations, agitation, depression, anxiety, irritability and sleep disorders. 4)Global CDR score of 0.5, 1 or 2 5)Right-handed 6)There is a family caregiver who lives at home, meets with the patient at least twice a week, and responds appropriately to the patient's BPSD.

Exclusion criteria

Exclusion criteria: 1)Patients who have abnormal findings on brain MRI that indicate other abnormalities than AD or DLB 2)Patients who have history of organic brain diseases, such as head trauma, subarachnoid hemorrhage, or neurosurgery 3)Patients who have history of psychiatric disorders, such as schizophrenia, bipolar disorder, alcoholism, or developmental disorder 4)Patients who have a serious physical illness 5)Patients who the researchers consider unsuitable for the research participants

Design outcomes

Primary

MeasureTime frame
Sub-item scores of the Neuropsychiatric Inventory (NPI)

Secondary

MeasureTime frame
NPI total score NPIQ total score Information on BPSD and care in real life Empathy disorder rating scale score

Countries

Japan

Contacts

Public ContactHiroaki Kazui

Kochi Medical School,Kochi University, Department of Neuropsychiatry

kazui@kochi-u.ac.jp088-880-2359

Outcome results

None listed

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