Disease-modifying Efficacy of Sitagliptin Therapy in Early-stage Parkinson's Disease

Brief summary

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.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym

ARREST-PD

status

NOT_YET_RECRUITING

phase

PHASE2

study type

INTERVENTIONAL

enrollment

160

sponsor

Yonsei University

conditions

Parkinson Disease

interventions

DRUG: Sitagliptin; DRUG: Sitagliptin placebo

start date

2026-12-15

start date type

ESTIMATED

primary completion date

2029-03-01

has results

false

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters