Disease-modifying Efficacy of Sitagliptin Therapy in Early-stage Parkinson's Disease
ConditionParkinson Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-80
SponsorYonsei University
About this trial
Parkinson's disease (PD) is a progressive neurodegenerative disorder pathologically characterized by the loss of dopaminergic neurons in the substantia nigra pars compacta and the accumulation of α-synuclein (α-syn) aggregates. To date, all approved treatments, including levodopa, are primarily limited to symptomatic relief, and no disease-modifying therapy (DMT) has been established to fundamentally slow or halt disease progression.
Large-scale epidemiological cohort studies conducted in Taiwan, Sweden, the United Kingdom, and other countries have consistently reported that, among patients with diabetes, DPP-4 inhibitor users had an approximately 30%-40% lower risk of developing Parkinson's disease compared with non-users.
This study aims to evaluate whether 72 weeks of treatment with sitagliptin (100 mg once daily), compared with placebo, delays the time to confirmed motor progression in patients with early-stage PD receiving stable levodopa monotherapy. Confirmed motor progression is defined as an increase of ≥5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score assessed in the OFF state.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 50 to 80 years, inclusive.
Participants diagnosed with Clinically Established Parkinson's Disease or Clinically Probable Parkinson's Disease according to the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015).
Participants diagnosed with Parkinson's disease within 3 years prior to screening.
Participants who are either treatment-naïve to antiparkinsonian medications at screening or receiving stable levodopa monotherapy, defined as maintenance of the same levodopa dose for at least 12 weeks immediately prior to screening without concomitant use of other antiparkinsonian medications.
Disqualifiers
Participants with suspected atypical parkinsonian syndromes, including progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal syndrome (CBS), or other atypical parkinsonian disorders.
Participants with vascular parkinsonism, drug-induced parkinsonism, or toxin-induced parkinsonism.
Participants with secondary parkinsonism due to causes such as normal-pressure hydrocephalus, brain tumor, or other identifiable secondary causes.
Participants currently receiving dopaminergic medications other than levodopa, including dopamine agonists, monoamine oxidase-B (MAO-B) inhibitors, catechol-O-methyltransferase (COMT) inhibitors, amantadine, or other antiparkinsonian medications.
Trial design
Design model
Parallel
Treatments tested in this trial
Sitagliptin
DrugSitagliptin 100 mg, one tablet orally once daily, with or without food, for 72 weeks.
Sitagliptin placebo
DrugOne placebo tablet orally once daily, with or without food, for 72 weeks. (The placebo will be manufactured to be indistinguishable from the investigational product in terms of appearance, color, size, and weight in order to maintain blinding.)
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: SitagliptinExperimental treatment 1 intervention
Group B: Sitagliptin placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to Confirmed Motor Progression (TTE)
Time from randomization (V2) to the first observed increase of ≥5 points from baseline in the MDS-UPDRS Part III score, confirmed at the next scheduled visit (approximately 12 weeks later), assessed in the OFF state in the morning prior to levodopa administration and after ≥12 hours since the last levodopa dose.
Time frame
From randomization every 12 weeks through Week 76.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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