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 3
  • Study Type

    Interventional
  • Intervention/Treatment

    oxaloacetate ...
  • Study Participants

    33
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.
Study Started
Dec 31
2012
Primary Completion
Oct 31
2014
Study Completion
Oct 31
2014
Results Posted
Mar 17
2016
Estimate
Last Update
Mar 17
2016
Estimate

Drug Oxaloacetate (OAA)

  • Other names: benaGene™

Drug Placebo

Oxaloacetate (OAA) Experimental

active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily

Placebo Placebo Comparator

placebo capsules that contain only 100 mg ascorbate, taken daily

Criteria

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

Summary

Oxaloacetate (OAA)

Placebo

All Events

Event Type Organ System Event Term Oxaloacetate (OAA) Placebo

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.

Oxaloacetate (OAA)

UPDRS Total Score at 4 months

34.9
units on a scale (Mean)
Standard Deviation: 10.4

UPDRS Total Score at Baseline

41.1
units on a scale (Mean)
Standard Deviation: 6.7

Placebo

UPDRS Total Score at 4 months

34.4
units on a scale (Mean)
Standard Deviation: 12.4

UPDRS Total Score at Baseline

42.9
units on a scale (Mean)
Standard Deviation: 10.8

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.

Oxaloacetate (OAA)

UPDRS ADL + Motor at 4 months

33.4
units on a scale (Mean)
Standard Deviation: 10.2

UPDRS ADL + Motor at Baseline

39.4
units on a scale (Mean)
Standard Deviation: 6.9

Placebo

UPDRS ADL + Motor at 4 months

33.9
units on a scale (Mean)
Standard Deviation: 11.7

UPDRS ADL + Motor at Baseline

42.2
units on a scale (Mean)
Standard Deviation: 10.7

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.

Oxaloacetate (OAA)

PDQ-39 total score at 4 months

14.4
percentage of total possible score (Mean)
Standard Deviation: 11.2

PDQ-39 Total Score at Baseline

13.0
percentage of total possible score (Mean)
Standard Deviation: 8.9

Placebo

PDQ-39 total score at 4 months

11.3
percentage of total possible score (Mean)
Standard Deviation: 7.4

PDQ-39 Total Score at Baseline

10.1
percentage of total possible score (Mean)
Standard Deviation: 7.8

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.

Oxaloacetate (OAA)

MoCA at 4 months

28.1
units on a scale (Mean)
Standard Deviation: 1.6

MoCA at Baseline

27.4
units on a scale (Mean)
Standard Deviation: 2.0

Placebo

MoCA at 4 months

27.6
units on a scale (Mean)
Standard Deviation: 2.4

MoCA at Baseline

27.2
units on a scale (Mean)
Standard Deviation: 2.4

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.

Oxaloacetate (OAA)

GDS at 4 months

5.8
units on a scale (Mean)
Standard Deviation: 5.4

GDS at Baseline

5.3
units on a scale (Mean)
Standard Deviation: 4.4

Placebo

GDS at 4 months

3.8
units on a scale (Mean)
Standard Deviation: 3.7

GDS at Baseline

3.3
units on a scale (Mean)
Standard Deviation: 3.1

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.

Oxaloacetate (OAA)

NMSQuest at 4 months

7.9
units on a scale (Mean)
Standard Deviation: 6.3

NMSQuest at Baseline

7.1
units on a scale (Mean)
Standard Deviation: 4.4

Placebo

NMSQuest at 4 months

6.9
units on a scale (Mean)
Standard Deviation: 4.6

NMSQuest at Baseline

6.2
units on a scale (Mean)
Standard Deviation: 4.4

Total

33
Participants

Age, Continuous

63.4
years (Mean)
Standard Deviation: 10.5

PD Duration

3.0
years (Mean)
Standard Deviation: 1.6

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Oxaloacetate (OAA)

Placebo

Drop/Withdrawal Reasons

Oxaloacetate (OAA)

Placebo