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Association between probucol use and risk of dementia (PRODEM-J): An observational study of older adults in Japan

The Association Between Probucol Use and the Risk of Dementia (PRODEM-J): A Retrospective Cohort Study Protocol

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001387415
Acronym
PRODEM-J – Probucol and Dementia in Japan
Enrollment
57000
Registered
2025-12-11
Start date
2023-12-05
Completion date
2023-12-05
Last updated
2026-01-05

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

Conditions

None listed

Brief summary

This study investigates whether probucol, a lipid-lowering medication, is associated with reduced risk of dementia in older adults. Using Japan's comprehensive healthcare database covering over 27 million people from 2014-2023, we will compare dementia rates between older adults prescribed probucol versus those prescribed statins. This research addresses a critical gap in dementia prevention research by examining whether probucol's demonstrated brain-protective effects in laboratory studies translate to real-world clinical benefits. The findings could inform clinical guidelines for medication selection in older adults at risk for cognitive decline.

Interventions

This retrospective cohort examines exposure to probucol (a lipid-lowering medication) compared to statin medications in adults aged >=50 years using the Japan Medical Data Centre (JMDC) claims database (2014-2023). Data collected: demographic characteristics, medical history, comorbidities, medication use, and dementia diagnoses recorded in claims data. Participant involvement: none; all data are de-identified and extracted directly from medical records within the JMDC database. Duration of obs

This retrospective cohort examines exposure to probucol (a lipid-lowering medication) compared to statin medications in adults aged >=50 years using the Japan Medical Data Centre (JMDC) claims database (2014-2023). Data collected: demographic characteristics, medical history, comorbidities, medication use, and dementia diagnoses recorded in claims data. Participant involvement: none; all data are de-identified and extracted directly from medical records within the JMDC database. Duration of observation: from the date of first eligible prescription (index date) until first dementia diagnosis, death, disenrollment, or end of study period (31 December 2023).

Sponsors

Curtin University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Adults aged 50 years or older • At least two prescriptions for probucol or statin medication during the study period (2014–2023) • Minimum of two filled prescriptions to ensure sustained exposure • Continuous enrolment in the JMDC database for at least 12 months prior to the first eligible prescription

Exclusion criteria

• Prior diagnosis of dementia before index prescription date • Prescriptions for study medications within 12 months of database entry • Dementia-related diagnostic codes within 12 months of baseline

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026