An interventional study of Vildagliptin 50 mg bid in Parkinson's Disease, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Not yet recruiting. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
Investigating the efficacy of Vildagliptin in delaying the progression of Parkinson's disease.
Exploring the effectiveness and safety of vildagliptin in delaying the progression of Parkinson's disease.
4,488 studies on the registry are indexed under Parkinson Disease; 1,083 are open to participants now.
This study's planned enrollment of 66 is above the median of 40 across 3,295 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1: Patients aged 40 to 75 years who were diagnosed with Parkinson's disease according to the UK Brain Bank criteria within the past three years.
2: Participants must have received an optimized and stable dopaminergic medication regimen (dopamine agonists, levodopa, or monoamine oxidase B [MAOB] inhibitors, or combinations of these medications) determined by the study site investigators for at least one month prior to the baseline initiation of the trial drug, with the expectation that the participants will be able to continue this regimen for at least six months.
3: Sign the informed consent form
Exclusion Criteria:
1: The key exclusion criterion is a score of at least 3 on the Hoehn and Yahr scale (ranging from 1 to 5, with higher scores indicating more severe disability), which indicates that Parkinson's disease has led to at least mild to moderate bilateral motor involvement due to some postural instability.
2: Presence of motor fluctuations or motor complications (or both).
3: The presence of severe psychiatric disorders, such as severe (treatment-resistant) anxiety, depression, or schizophrenia, that cannot be effectively controlled by medication.
4: Atypical or secondary Parkinsonism
5: A score of 18 or lower on the Montreal Cognitive Assessment (MoCA) (range: 0 to 30, with a score of 26 or higher indicating normal cognitive function), indicating at least mild cognitive impairment.
6: Diabetes mellitus (Type 1 and Type 2), as well as prior treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors or glucagon-like peptide-1 (GLP-1) receptor agonists.
7: Individuals with severe renal impairment (creatinine clearance \<30 ml/min), active liver disease, history of drug or alcohol abuse, idiopathic pancreatitis, chronic pancreatitis, or a history of pancreatectomy.
8: Individuals with a body mass index (weight in kilograms divided by the square of height in meters) less than 18.5, or those with a weight change exceeding 5 kilograms within the 3 months prior to screening.
9: Currently participating in other relevant clinical trials involving pharmacological or surgical treatments.
10: Other situations where the investigator believes that the subject is unable to participate in or cooperate with the entire assessment process of the clinical trial.
Traditional dopamine preparations combined with vildagliptin treatment
Drug: Vildagliptin 50 mg bid
Only traditional dopamine preparations are used for treatment without additional intervention
Vildagliptin 50 mg bid for 12months
The change in the third part of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) after 12 months of oral Vildagliptin treatment compared to baseline
MDS-UPDRS Part III mainly includes motor symptoms (total score 0-132 points), with scores ranging from 0 to 132 The higher the symptom, the more severe it is.
Time frame: baseline, pre-intervention；12 months，month 12
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital, Sun Yat-Sen University