An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's Disease - NCT00853879-11030(Clinical Trial 275359)
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Manhasset |
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NY |
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11030 |
| Conditions: |
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Parkinson's Disease |
| Purpose: |
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This study is being conducted to assess the impact of folate and L-methylfolate on the
progression of Parkinson's. The investigators are specifically looking for the effect of
these nutritional supplements in Parkinson's patients who have an antibody that effects
their body's utilization of folate. An antibody is a protein produced by the body's immune
system to recognize foreign substances. Normally, people do not have an antibody that
prevents folate from working properly in the brain but it appears that some people may have
such an antibody. Folate is an important vitamin that takes part in many critical cell
functions so an antibody that prevented it from entering the brain properly could cause or
worsen certain neurological disorders like Parkinson's. The results of this preliminary
study will help determine whether it is reasonable to proceed with further study of any of
these supplements for the treatment of Parkinson's. Patients interested in participating
will have a blood test to see if they have folate antibodies. Patients with the antibody
will be eligible to further participate in the study. The investigators will measure the
effects of folate and L-methylfolate on Parkinson's disease by measuring the change in your
Parkinson's disease symptoms over three months of treatment. The investigators will also be
looking at the blood of some individuals who do not have Parkinson's. This is called a
control group and will allow us to compare how common the folate antibody is in the general
population compared with the Parkinson's population.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- PD subjects:
- Diagnosis of Parkinson's based upon the presence of 2 or more of the cardinal
clinical features of the disease as determined by a movement disorders
specialist.
- Age > 30.
- Able to provide informed consent.
- All anti-Parkinson's medications will be permitted but all evaluations will be
done in the medication OFF state (at least 12 hours following the last dose of
medication).
- Healthy Controls *Age > 30
Exclusion Criteria:
- PD Subjects:
- Age < 30.
- Presence of concomitant active neurological disorders as deemed significant by
the investigator.
- History of clinically significant diabetes, vascular disease, renal, thyroid or
hepatic dysfunction or of Leber's optic neuropathy as determined by the
investigator.
- History of significant medical illness as determined by the investigators.
- The following medications will be excluded: thiazide diuretics, azathioprine,
phenytoin, phenobarbital, primidone, sulfa-containing medications, cimetidine,
anti-tuberculosis medications, methotrexate, chemotherapeutic agents and oral
contraceptives.
- Subjects taking vitamin supplementation in excess of one daily standard
multivitamin.
- Pregnancy (excluded not for perceived risk but because most pregnant women are
taking supplemental folate).
- Healthy Controls:
- Age < 30
- Any known active neurological condition deemed significant by the investigator.
- History of significant, active renal or hepatic dysfunction as determined by the
investigator.
- History of significant active medical illness as determined by the
investigators.
- The following medications will be excluded: thiazide diuretics, azathioprine,
phenytoin, phenobarbital, primidone, sulfa-containing medications, cimetidine,
anti-tuberculosis medications, methotrexate, chemotherapeutic agents and oral
contraceptives.
- Subjects taking vitamin supplementation in excess of one standard daily
multivitamin.
- Pregnancy (most pregnant women are taking folate). |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 7, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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