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Effects of equfina on cognition

Open-label study of safinamide mesylate on cognition in Parkinson's disease patients with/without amyloid-beta pathology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041240076
Enrollment
52
Registered
2024-08-21
Start date
2024-12-03
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

Parkinson's disease Parkinson's disease

Interventions

Equfina 50mg tablet) will be taken orally once a day after breakfast for 24 weeks.
D008996
MAO-B inhibitors

Sponsors

Ono Kenjiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women aged 50 years or older on the date of consent 2) Patients with Parkinson's disease 3) Patients who receives treatments with levodopa 4) Patients with wearing-off 5) MoCA-J score of 20 to 25 points 6) Patients who have undergone amyloid-beta pathology confirmation within the past 3 years or are willing to test for amyloid-beta pathology confirmation for this study. 7) Patients who does not receive treatments for cognitive decline, nor are not willing to start new treatment for cognitive decline. 8) Patinets who does not have intension to change anti-Parkinson's drugs other than adding Equfina 9) Patients who have a study partner. 10) Patients who have obtained written informed consent to participation of this study.

Exclusion criteria

Exclusion criteria: 1) Patients currently using MAO-B inhibitors 2) Patients currently participating in other clinical trials 3) Patients who are unsuitable for research participants judged by the Principal Investigator or Co-Investigators

Design outcomes

Primary

MeasureTime frame
The primary outcome is change in cognitive performance from baseline to 24 weeks. Cognition is assessed using the MoCA-J score.

Secondary

MeasureTime frame
The secondary outcomes are changes in motor and non-motor symptoms of Parkinson's disease; changes in cognitive performance, and changes in blood biomarkers from baseline to 24 weeks.

Contacts

Public ContactMoeko Shinohara

Kanazawa University Hospital

m-nohara@med.kanazawa-u.ac.jp+81-762652292

Outcome results

None listed

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