A Pilot Study of Oxaloacetate in Subjects With Treated PD

Study Overview
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Brief Summary
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The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and complete two safety follow-up phone calls over a 4 month period.

Official Title
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A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: Oxaloacetate (OAA)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to give informed consent and follow instructions per the protocol Diagnosis of idiopathic PD within 7 years of diagnosis Taking stable doses of levodopa and would not predictably need adjustment in PD medications for 4 months Unified Parkinson's Disease Rating Scale (UPDRS) II + III at least 30 points at baseline Exclusion Criteria: Previously taken Oxaloacetate Participation in other drug studies or use of other investigational products within 30 days prior to baseline In the Investigator's opinion, any unstable or clinically significant condition that would impair the subjects' ability to comply with study follow-up Other known or suspected cause of parkinsonism

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxaloacetate (OAA)<br>active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily | Drug: Oxaloacetate (OAA)<br> <br> * Other names: benaGene™;|
| Placebo Comparator: Placebo<br>placebo capsules that contain only 100 mg ascorbate, taken daily | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale (UPDRS) Total Score | The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). The total scores represents the sum of each of these sections for a total of 176 points with a higher score representing greater dysfunction. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score | The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). This measure examined the ADL + Motor subscales which have a total of 160 points with a higher score representing greater dysfunction. | 4 months | 
| Parkinson's Disease Questionnaire - 39 (PDQ-39) | The PDQ-39 is a measure of quality of life in Parkinson's disease patients. It has 39 questions each with a response from 0-4 for a total of 156 points. The total score is calculated as a percentage so the scores of the 39 items are added and divided by 156 and multiplied by 100. The higher the score the worse quality of life. | 4 months | 
| Montreal Cognitive Assessment (MoCA) | The MoCA is an assessment of cognitive function. The total possible score ranges from 0 to 30 points with a lower score representing greater cognitive impairment. | 4 months | 
| Geriatric Depression Scale (GDS) | The GDS is a measure of depression. The scale has 30 yes/no questions. Each question has a maximum score of 1 and a total possible score ranging from 0 to 30. The higher the score the greater the depression. | 4 months | 
| NonMotor Symptom Questionnaire (NMSQuest) | The NMSQuest is a 30 item questionnaire with 30 yes/no questions. There is a total of 30 points with each yes score representing 1 point and therefore the higher the score the greater number of nonmotor symptoms present. The score can range from 0 to 30. | 4 months |