Parkinson's Disease
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
Sponsors
Terra Biological LLC
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) Total Score | 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score | 4 months | 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. |
| Parkinson's Disease Questionnaire - 39 (PDQ-39) | 4 months | 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. |
| Montreal Cognitive Assessment (MoCA) | 4 months | 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. |
| Geriatric Depression Scale (GDS) | 4 months | 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. |
| NonMotor Symptom Questionnaire (NMSQuest) | 4 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxaloacetate (OAA) active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
Oxaloacetate (OAA) | 18 |
| Placebo placebo capsules that contain only 100 mg ascorbate, taken daily
Placebo | 15 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Oxaloacetate (OAA) | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 5 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 10 Participants | 21 Participants |
| Age, Continuous | 62.4 years STANDARD_DEVIATION 11.4 | 64.6 years STANDARD_DEVIATION 9.4 | 63.4 years STANDARD_DEVIATION 10.5 |
| PD Duration | 2.9 years STANDARD_DEVIATION 1.5 | 3.1 years STANDARD_DEVIATION 1.7 | 3.0 years STANDARD_DEVIATION 1.6 |
| Region of Enrollment United States | 18 participants | 15 participants | 33 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 18 | 4 / 15 |
| serious Total, serious adverse events | 0 / 18 | 0 / 15 |
Outcome results
Primary
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.
Time frame: 4 months
Population: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxaloacetate (OAA) | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score | UPDRS Total Score at Baseline | 41.1 units on a scale | Standard Deviation 6.7 |
| Oxaloacetate (OAA) | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score | UPDRS Total Score at 4 months | 34.9 units on a scale | Standard Deviation 10.4 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score | UPDRS Total Score at Baseline | 42.9 units on a scale | Standard Deviation 10.8 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score | UPDRS Total Score at 4 months | 34.4 units on a scale | Standard Deviation 12.4 |
p-value: 0.5t-test, 2 sided
Secondary
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.
Time frame: 4 months
Population: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxaloacetate (OAA) | Geriatric Depression Scale (GDS) | GDS at Baseline | 5.3 units on a scale | Standard Deviation 4.4 |
| Oxaloacetate (OAA) | Geriatric Depression Scale (GDS) | GDS at 4 months | 5.8 units on a scale | Standard Deviation 5.4 |
| Placebo | Geriatric Depression Scale (GDS) | GDS at Baseline | 3.3 units on a scale | Standard Deviation 3.1 |
| Placebo | Geriatric Depression Scale (GDS) | GDS at 4 months | 3.8 units on a scale | Standard Deviation 3.7 |
Comparison: Comparison between groups in change from baseline to 4 monthsp-value: 0.9t-test, 2 sided
Secondary
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.
Time frame: 4 months
Population: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxaloacetate (OAA) | Montreal Cognitive Assessment (MoCA) | MoCA at Baseline | 27.4 units on a scale | Standard Deviation 2 |
| Oxaloacetate (OAA) | Montreal Cognitive Assessment (MoCA) | MoCA at 4 months | 28.1 units on a scale | Standard Deviation 1.6 |
| Placebo | Montreal Cognitive Assessment (MoCA) | MoCA at Baseline | 27.2 units on a scale | Standard Deviation 2.4 |
| Placebo | Montreal Cognitive Assessment (MoCA) | MoCA at 4 months | 27.6 units on a scale | Standard Deviation 2.4 |
Comparison: Comparison between groups in the change from baseline to 4 monthsp-value: 0.77t-test, 2 sided
Secondary
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.
Time frame: 4 months
Population: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxaloacetate (OAA) | NonMotor Symptom Questionnaire (NMSQuest) | NMSQuest at Baseline | 7.1 units on a scale | Standard Deviation 4.4 |
| Oxaloacetate (OAA) | NonMotor Symptom Questionnaire (NMSQuest) | NMSQuest at 4 months | 7.9 units on a scale | Standard Deviation 6.3 |
| Placebo | NonMotor Symptom Questionnaire (NMSQuest) | NMSQuest at Baseline | 6.2 units on a scale | Standard Deviation 4.4 |
| Placebo | NonMotor Symptom Questionnaire (NMSQuest) | NMSQuest at 4 months | 6.9 units on a scale | Standard Deviation 4.6 |
Comparison: Comparison between groups in change from baseline to 4 monthsp-value: 0.95t-test, 2 sided
Secondary
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.
Time frame: 4 months
Population: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxaloacetate (OAA) | Parkinson's Disease Questionnaire - 39 (PDQ-39) | PDQ-39 Total Score at Baseline | 13.0 percentage of total possible score | Standard Deviation 8.9 |
| Oxaloacetate (OAA) | Parkinson's Disease Questionnaire - 39 (PDQ-39) | PDQ-39 total score at 4 months | 14.4 percentage of total possible score | Standard Deviation 11.2 |
| Placebo | Parkinson's Disease Questionnaire - 39 (PDQ-39) | PDQ-39 Total Score at Baseline | 10.1 percentage of total possible score | Standard Deviation 7.8 |
| Placebo | Parkinson's Disease Questionnaire - 39 (PDQ-39) | PDQ-39 total score at 4 months | 11.3 percentage of total possible score | Standard Deviation 7.4 |
Comparison: Comparison between groups in the change from baseline to 4 monthsp-value: 0.97t-test, 2 sided
Secondary
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.
Time frame: 4 months
Population: Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxaloacetate (OAA) | Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score | UPDRS ADL + Motor at Baseline | 39.4 units on a scale | Standard Deviation 6.9 |
| Oxaloacetate (OAA) | Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score | UPDRS ADL + Motor at 4 months | 33.4 units on a scale | Standard Deviation 10.2 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score | UPDRS ADL + Motor at Baseline | 42.2 units on a scale | Standard Deviation 10.7 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score | UPDRS ADL + Motor at 4 months | 33.9 units on a scale | Standard Deviation 11.7 |
Comparison: Comparison of change between groups from baseline to 4 monthsp-value: 0.51t-test, 2 sided