This study is to evaluate the safety and efficacy of sustained release (SR)-Exenatide (PT320, Q1W and Q2W) in the treatment of patients with early Parkinson's disease (PD).
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel comparison, phase IIa clinical study to evaluate the efficacy and safety of sustained release (SR)-Exenatide (PT320) in the treatment of patients with early Parkinson's disease (PD). Exenatide (GLP-1) has been approved by the Food and Drug Administration (FDA) to treat patients with Type 2 Diabetes (T2D) and obesity. In addition, several research groups have confirmed that Exenatide has beneficial aspects due to the neuroprotective effects in neuronal cells in patients with PD. Peptron has developed a sustained-release (SR)-Exenatide, (PT320, Q1W and Q2W), which has shown a higher Blood-Brain Barrier (BBB) penetration rate and better patient compliance. Thus, the objective of this study is to evaluate the effect of PT320 on symptom improvement and the inhibition of disease progression in the treatment of patients with early Parkinson's disease. Also, pharmacokinetic analysis of PT320 in blood cerebrospinal fluid (CSF) and exosome analysis of biomarkers related to Exenatide will be being tested, as exploratory measurements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
PT320 2.0mg Placebo
Exenatide slowly released formulation
Exenatide slowly released formulation
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea
Change of MDS-UPDRS part 3 score
Change of MDS-UPDRS (Movement Disorder Society -Unified Parkinson's Disease Rating Scale ) part 3 score from baseline at 48 weeks. The MDS-UPDRS has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). The MDS-UPDRS consists of five measures, 0(normal) to 4(severe), according to each item, and is evaluated as the total score per part of Part 1 to 4. A 0 means there is no disability, and the higher the score, the more the disability is reflected.
Time frame: 48 week
SNBR (specific to non-specific binding ratio) confirmed by PET scan
Change of SNBR (specific to non-specific binding ratio) from baseline at 48 weeks, confirmed by PET scan
Time frame: 0 and 48 weeks
MDS-UPDRS part 3 score
Change of MDS-UPDRS (Movement Disorder Society -Unified Parkinson's Disease Rating Scale ) part 3 scores from baseline at 24 and 60 weeks. The MDS-UPDRS has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). The MDS-UPDRS consists of five measures, 0(normal) to 4(severe), according to each item, and is evaluated as the total score per part of Part 1 to 4. A 0 means there is no disability, and the higher the score, the more the disability is reflected.
Time frame: 0, 24 and 60 weeks
MDS-UPDRS part 1, 2 and 4 scores
Changes of MDS-UPDRS (Movement Disorder Society -Unified Parkinson's Disease Rating Scale ) part 1, 2 and 4 scores from baseline at 24, 48 and 60 weeks. The MDS-UPDRS has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). The MDS-UPDRS consists of five measures, 0(normal) to 4(severe), according to each item, and is evaluated as the total score per part of Part 1 to 4. A 0 means there is no disability, and the higher the score, the more the disability is reflected.
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Seoul National University Hospital
Seoul, South Korea
Time frame: 0, 24, 48 and 60 weeks
K-PDQ-39 score
Change of K-PDQ-39 (korean-The Parkinson's Disease Questionnaires-39) score from baseline at 48 and 60 weeks. PDQ-39 is an assessment of Parkinson's disease and comprises a total of 39 questions. Based on the past month's experience, each item consists of a five-point scale of 0(never) to 4 (always) and is checked by the test subjects themselves. The total score of PDQ-39 is evaluated as a percentage of 0-100%, and as the score increases, the symptom becomes more severe.
Time frame: 0, 48 and 60 weeks
MoCA-K score
Change of MoCA-K (Montreal Cognitive Assessment-Korean) score from baseline at 24, 48 and 60 weeks. MoCA-K is designed to evaluate mild cognitive disorders. The raters evaluate cognitive functions such as attention and concentration, memory, language, conceptual thinking, calculations, and orientation. The execution time takes about 10 minutes and is evaluated by the sum of the scores of each item. A perfect score of 30 points or more is considered normal.
Time frame: 0, 24, 48 and 60 weeks
K-NMSS score
Change of K-NMSS (Korean-Non Motor Symptoms Scale) score from baseline at 24, 48 and 60 weeks. K-NMSS evaluates non-motorative symptoms of Parkinson's disease. It consists of a total of 30 questions, separated by nine aspects: cardiovascular function, sleep/ fatigue, sexual function, and other non-motor symptoms. The evaluation period is evaluated based on the experience of the last month. For each aspect, the grade point is evaluated as the degree of severity (level 0-3) and frequency (1-4), and the evaluation score is obtained by multiplying the degree and frequency of severity. The K-NMSS has a range of 0-360 points, and the higher the score, the more severe the symptoms are judged.
Time frame: 0, 24, 48 and 60 weeks
Each percentage of subjects and changing patterns in modified Hoehn and Yahr stage
Percentage of subjects per modified Hoehn and Yahr stage and the changing patterns from baseline at 24, 48 and 60 weeks
Time frame: 0, 24, 48 and 60 weeks
Change of the L-dopa dosage of subjects
Starting time of L-dopa treatment and percentage of subjects who have L-dopa treatment at each visit.
Time frame: 0, 2, 4, 8, 12, 24, 36, 48 and 60 weeks