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Official Study Title: An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-Methylfolate in Parkinson's Disease
Sponsor: GCRC, The Feinstein Institute for Medical Research
Clinicaltrials.gov ID: NCT00853879
Study ID: GCRC 0143

Summary

This study is being conducted to assess the impact of folate and L-methylfolate on the progression of Parkinson's disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD). The investigators are specifically looking for the effect of these nutritional supplements in people with Parkinson's 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. People interested in participating will have a blood test to see if they have folate antibodies. People with PD who have 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 the participant’s PD 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  Control Group (Comparison Group)Clinical trial participants who are given either a standard treatment or a placebo instead of the investigational drug or treatment being tested. and will allow them to compare how common the folate antibody is in the general population compared with the Parkinson's population.

Study Phase

Not Applicable
What is a study phase?

Symptoms Addressed: Study does not address symptoms

Study does not address symptoms

Time Commitment

• Less than six months

Eligibility

• Minimum Age: 30
• Gender(s) Accepted: Either

Inclusion Criteria

• Diagnosis of Parkinson's based upon the presence of 2 or more of the cardinal clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. features of the disease as determined by a movement disorders specialist.  Movement Disorders SpecialistA neurologist with advanced training to diagnose and treat movement disorders, such as Parkinson's disease.
• Age is over 30.
• Able to provide informed consent.  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial.
• 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).
  

Exclusion Criteria

• Presence of additional other 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.
• Participants 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).
  

Enrollment

Expected Enrollment: 260 (US)
Date Enrollment Began: Dec 2006
Date Enrollment Ends: Dec 2009
Last Updated Date: Sep 17 2009
Trial Post Date: Sep 10 2009
Website: http://clinicaltrials.gov/ct2/show/NCT00853879?term=NCT00853879&rank=1

Primary Contacts and Locations

New York

• Gulru Sharifova
  gsharifo@nshs.edu
  Phone: (516) 562-1012
  The Feinstein Institute For Medical Research
  Manhasset, NY 11030
  USA
  
• Julie Martusciello, RN
  jmartusc@nshs.edu
  Phone: (516) 562-1012
  The Feinstein Institute For Medical Research
  Manhasset, NY 11030
  USA