Parkinson's disease
Conditions
Interventions
Semaglutide 7mg group
semaglutide 3mg once daily for 4weeks, then 7mg once daily for 32weeks
Semaglutide 14mg group
semaglutide 3mg once daily for 4weeks, then 7mg once daily for 4weeks, then 14mg once daily for 28weeks
placebo group
once daily for 36weeks
Sponsors
Kimura Yasuyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 20-80 years at the time of informed consent 2) Diagnosed with PD by a neurologist [In terms of diagnosis, meet the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria (UKPDSBB criteria) International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic criteria (MDS-PD criteria, clinically established PD) or MDS-early PD criteria] 3) On-time Modified Hoehn and Yahr classification <=2.5 4) Receiving stable PD medication for 4 weeks prior to V1. For MAO-B inhibitors, stable dose and dosage for 12 weeks prior to V1. 5) With written informed consent
Exclusion criteria
Exclusion criteria: 1) Diagnosed or supected with Parkinson's syndrome other than PD 2) Familial PD 3) Showing abnormalities with brain MRI or CT that may affect DaTscan results 4) Cannot come to the hospital in an off-state 5) Moderate-severe depression with PHQ-9>=16 6) Cognitive dysfunction with MMSE<=23 or FAB<=11 7) Receiving device aided therapy, previous history of irreversible brain surgery, previous history of gene therapy or cell transplantation as PD treatment 8) Currently participating in another investigational study and previously participated in investigational study of disease-modifying therapies 9) Body mass index<18.5 10) Type1 or Type2 diabetes mellitus 11) Severe gastrointestinal disorder, severe Gastro esophageal reflux disease and previous history of gastrectomy 12) Previous history of Pancreatitis 13) Kidney dysfunction with eGFR<30mL/min 14) Decompensated cirrhosis 15) Diagnosed or supected Thyroid tumor 16) Previous history or family history of Multiple endocrine neoplasia type2 17) Pregnant, breastfeeding and unable to contraception during the study period 18) Receiving medication to be taken upon waking and unable to change or discontinue during the study period 19) Eat, drink, or take oral medication within 8 hours prior to taking the study drug 20) Previous use of GLP-1 receptor agonists, including semaglutide 21) Answer "yes" to item 4 or item 5 of the C-SSRS suicidal ideation. Current or past suicidal behavior or received treatment for suicidal attempts or plans 22) Unable to DaTscan due to alcohol sensitivity 23) Other, unqualified for this study decided by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in clinically defined off-state MDS-UPDRS part 3 score at 48week | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of semaglutide - Changes in the clinically defined off-state MDS-UPDRS part 3 score at 36 weeks - Changes in the MDS-UPDRS parts 1,2,3, and 4 scores in the ON medication state at 36 weeks - Changes in the MDS-UPDRS parts 1,2,3, and 4 scores in the ON medication state at 48 weeks - Change in the Japanese version of the Parkinson's Disease Questionnaires-39 (J-PDQ-39) score at 36 and 48 weeks - Change in the Montreal Cognitive Assessment-Japanese (MoCA-J) score, Symbol Digit Modality Test (SDMT) score, Digit Span score, noise pareidolia test (NPT) score, and Japanese version of the Patient Health Questionnaire-9 (J-PHQ-9) at 48 weeks - Patient Global Impression Change score at 36 and 48 weeks - Quantitative change in Dopamine Transporter availability at 48 weeks - Levodopa Equivalent Daily Dose | — |
Contacts
Public ContactToru Koda
The University of Osaka Hospital
Outcome results
None listed