Effects of equfina on cognition

JRCT ID: jRCTs041240076

Registered date:21/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 21/08/2024
• Target sample size: 52
• Study type: Interventional
• Intervention(s): Equfina 50mg tablet) will be taken orally once a day after breakfast for 24 weeks.

Outcome(s)

• Primary Outcome: The primary outcome is change in cognitive performance from baseline to 24 weeks. Cognition is assessed using the MoCA-J score.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Ono Kenjiro
• Source(s) of Monetary Support: Eisai