None listed
Conditions
Interventions
Drug : This study has been designed as a randomized, double-blind, placebo-controlled, parallel-group study.
Only participants who are finally confirmed to be eligible for the trial will be randomly
Sponsors
Glaceum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to read, understand, and provide written consent for the trial, comply with the clinical trial protocol, and communicate any adverse events (AEs) and other clinically significant information to the investigator (able to complete the evaluation, including walking or using walking aids). 2. Adult men and women between the ages of 40 and 75 at Screening. 3. Diagnosed with Parkinson's disease according to the UK Parkinson's Disease Society (UKPDS) Brain Bank clinical diagnostic criteria and confirmed the reduction of dopamine transporter on 18F-FP-CIT PET imaging at Screening. 4. Diagnosed with Parkinson's disease within the last 24 months. 5. Hoehn-Yahr stage = 2 6. Eligible females will be: - females of childbearing potential who are not pregnant, evidenced by a negative serum hCG pregnancy test at Screening - non-lactating, or - surgically sterile (defined as documented bilateral tubal ligation, bilateral tubal occlusion, bilateral oophorectomy, hysterectomy) or postmenopausal. * Definition of menopause - 50 years or over: 12 or more consecutive months without menstruation, in the absence of other conditions. - Less than 50 years: FSH level is > 40 IU/L and 12 or more consecutive months without menstruation, in the absence of other conditions.
Exclusion criteria
Exclusion criteria: 1. Clinically significant new illness, per Investigator judgment, in the 4 weeks before Screening and during the screening period. 2. Global Deterioration Scale (GDS) = 4 at Screening. 3. Have clinically significant depression as indicated by a Korean Beck Depression Inventory II score (K-BDI-II) > 18 at Screening. 4. BMI less than 18.5 kg/m2 at Screening. 5. Have the following laboratory test results: - Clinically significant abnormal hepatic (i.e., AST or ALT greater than 2.5x ULN, or total bilirubin greater than 2x ULN, unless documented Gilbert's syndrome) - Renal function laboratory test (i.e., GFR < 60 mL/min). 6. Have the following medical history: - Diagnosed with or suspected to have *Parkinson-plus syndromes (PPS) *PPS: Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Diffuse Lewy Body Disease, etc. - Tremor-dominant Parkinson's disease, per Investigator judgment. - Symptoms or signs indicative of neurological functional impairment or known abnormalities in brain CT or MRI imaging. - A history of severe heart failure (NYHA class III ~ IV), stroke, cerebral ischemic attacks, or seizures within the past year before screening; or those with a history of myocardial infarction or unstable angina within the last 6 months before screening. - Have undergone surgery for Parkinson's disease treatment (e.g., cholecystectomy, deep brain stimulation, fetal tissue transplantation) or any other major brain surgery. - Diagnosed with malignant tumors within the past 5 years before screening (except for adequately treated basal cell carcinoma, cervical intraepithelial neoplasia, thyroid cancer, or flat epithelial atypia). - Diagnosed with secondary Parkinsonism (drug-induced Parkinsonism, normal pressure hydrocephalus, vascular Parkinsonism). 7. Have swallowing problems 8. Have clinically significant dizziness, nausea, per Investigator's judgment. 9. Currently taking any of the following medications and have the willingness and ability to continue taking them throughout the clinical trial period: - Within the 4 weeks before baseline, taking any Parkinson's disease medications, including dopamine agonists, dopamine-depleting enzyme inhibitors [monoamine oxidase inhibitors (MAOi), COMT (catechol-O-methyltransferase) inhibitors], non-dopaminergic drugs (anticholinergic agents, amantadine, etc.), and others PD medications (In case of irreversible MAO-B inhibitor, within the 90 days before baseline) - Within the 12 weeks before screening, have used systemic steroids continuously for 7 days or longer. - Within the 12 weeks before baseline, taking levodopa or levodopa combinations (except history of levodopa use for more than 4 weeks) - Currently taking medications known to be substrates of breast cancer resistant protein (BCRP) at screening (e.g., rosuvastatin, serpalan, etc.) (Note: If switched to another drug of the same class, the subject may be eligible for inclusion). - taking of any medication within 6 months of Screening that can alter reproductive hormone levels, either as the intended effect or as a side effect, including: anabolic steroids, androstenedione, bicalutamide, cimetidine, dehydroepiandrosterone, diethylstilbestrol, other estrogens, dutasteride, finasteride, glucocorticoids (e.g., prednisone, cortisone, hydrocortisone, and decadron), oral ketoconazole, megestrol acetate,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in MDS-UPDRS Part III Subscore | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in MDS-UPDRS Part III Subscore;Change From Baseline in MDS-UPDRS Part II + Part III;Change From Baseline in CGI-C score;Change From Baseline in K-NMSS score;Change From Baseline in Modified Hoehn-Yahr stage;Change From Baseline in PET SNBR (Specific to Non-specific Binding Ratio) in the putamen, acudate and nucleus;Drop-out rate due to taking anti-parkinson drug | — |
Countries
Korea, Republic of
Contacts
Public ContactJoong-Seok Kim
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed