Clinical Trial of Vildagliptin in Early Parkinson's Disease

NCT ID: NCT06951334

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

Brief Summary

Investigating the efficacy of Vildagliptin in delaying the progression of Parkinson's disease.

Detailed Description

Exploring the effectiveness and safety of vildagliptin in delaying the progression of Parkinson's disease.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional medication plus Vildagliptin treatment group

Traditional dopamine preparations combined with vildagliptin treatment

Group Type: EXPERIMENTAL

Vildagliptin 50 mg bid

Intervention Type: DRUG

Vildagliptin 50 mg bid for 12months

conventional medication treatment group

Only traditional dopamine preparations are used for treatment without additional intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vildagliptin 50 mg bid

Vildagliptin 50 mg bid for 12months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhang Nu

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FirstSunYetSen

Identifier Type: OTHER

Identifier Source: secondary_id

[2024]746

Identifier Type: -

Identifier Source: org_study_id