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NOT YET RECRUITING
NCT06612593
PHASE2

Cilostazol in Parkinson's Disease

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

Parkinson's disease is the second most common neurodegenerative diseases. The conventional treatment for PD has included dopaminergic treatment as Levodopa\\carbidopa or dopamine agonists, anti-cholinergics, MAOI, catechol-o-methyl transferase (COMT) inhibitors, and amantadine. Although these options have been found to be effective, they could only improve the disease symptoms, but do not modify the disease progression. Hence, researchers have focused on developing disease-modifying agents to stop or slow the progression acting as neuroprotective agents. Since the inflammation and oxidative stress play an important role in the pathophysiologic progression of PD, recent studies have investigated the mitigation of the disease pathology through anti-inflammatory and anti-oxidant agents. Cilostazol has been found to have anti-inflammatory, antioxidant, and neuroprotective effect, and has been evaluated through two animal studies to prove that it possess these effects through dampening NF-κB, and its downstream effectors including TNF-α and IL-1β, reversing the activation of glycogen synthase kinase-3 β (GSK-3β), a pivotal effector in neuronal apoptosis, contributing in preserving dopaminergic neuron integrity clarifying the enhance motor activity, activating nuclear factor erythroid-related factor 2/ heme oxygenase 1 (Nrf2/HO-1), suppressing High mobility group box 1 protein/Toll-like receptor 4 (HMGB1/TLR4) axis, and upregulatig Phosphoinositide 3-kinases/ Protein kinase B (PI3K/Akt) besides mammalian target of rapamycin (mTOR) inhibition. Hence, Cilostazol might be a potential candidate to improve the clinical outcome in PD patients.

Official title: The Effect of Cilostazol on the Clinical Outcome of Patients with Parkinson's Disease

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-10-01

Completion Date

2025-10-01

Last Updated

2024-09-25

Healthy Volunteers

No

Interventions

DRUG

Cilostazol

2 tablets of 50 mg cilostazol will be received for 4 weeks, then the does will be 2 tablets of 100 mg cilostazol twice daily for 20 weeks

DRUG

Placebo

The patient will receive 2 tablets twice daily

DRUG

Standard treatment

It includes Levodopa with a dose of 375 to 1000mg daily and Dopamine agonists with a dose of 1.5 to 5 mg daily.

Locations (1)

Ain Shams University Hospital

Cairo, Egypt