Title
A Pilot Study of Oxaloacetate in Subjects With Treated PD
A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)
Phase
Phase 2/Phase 3Lead Sponsor
University of KansasStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Parkinson's DiseaseIntervention/Treatment
oxaloacetate ...Study Participants
33The 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.
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
placebo capsules that contain only 100 mg ascorbate, taken daily
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
Event Type | Organ System | Event Term | Oxaloacetate (OAA) | Placebo |
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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.
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.
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.
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.
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.
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.