Protocol Number: 04-N-0236

Title:

Investigation of Biomarkers in Parkinson's Disease

Number:

04-N-0236

Summary:

This study will identify abnormalities of a protein called alpha synuclein that is found in the brain of patients with Parkinson's disease and related disorders to see if it can serve as a disease marker. There is currently no treatment that will cure or delay progression of Parkinson's disease. Thus, there is a need to find disease markers that can help diagnosis the disease, follow its progression, and monitor the effects of treatment. This study will examine and compare alpha synuclein from blood and cerebrospinal fluid (the fluid that bathes the brain and spinal cord) of patients with Parkinson's disease, patients with variants of the disease, and healthy normal volunteers to determine differences in the protein that might serve as a disease marker.

Patients with neurodegenerative disorders such as Parkinson's disease and Parkinson plus disorders (other diseases that are variants of Parkinson's disease) and healthy volunteers between 18 and 80 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, neurological evaluation, and blood tests. A brain MRI (magnetic resonance imaging) scan is done if needed for diagnosis.

All participants have a blood sample drawn and a lumbar puncture (spinal tap). For the lumbar puncture, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. The fluid is analyzed for specific proteins and chemicals that are leaked from the brain in various disease states and that cannot be measured in blood.

Participation of healthy volunteers is completed after the blood draw and lumbar puncture. Patients with Parkinson's and related diseases return to the clinic once a year for 2 years for a repeat blood draw and lumbar puncture to follow changes in the alpha synuclein protein and to monitor disease progression. Patients with specific proteins of interest may also be asked to come for a repeat lumbar puncture 6 months after the first procedure.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA

Patients between ages 18 to 80 years who are able to give informed consent.

Before any study related procedure is undertaken, the subject or his representative must sign a consent form.

In those individuals with dementia, a legal guardian will need to sign the consent form prior to any procedure.

EXCLUSION CRITERIA

Medical disorders such as lupus, diabetes, serious heart and kidney disease, thyroid dysfunction and any chronic medical illness with the exception of hypertension and hypercholesterolemia.

Patients with any history of bleeding diatheses or abnormal platelets or PT/PTT. Patients using anticoagulants and other drugs which can alter PT/PTT.

Patients with evidence of elevated intracranial pressure based on the imaging studies.

Pregnant women

Children

Special Instructions: Currently Not Provided

Keywords:

Parkinsonism

Biomarker

Proteomics

Parkinson's Disease

Neurodegenerative Disorders

Recruitment Keywords:

Parkinson Disease

PD

Neurodegenerative Disorders

Conditions:

Parkinson Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Jellinger KA. Neuropathological spectrum of synucleinopathies.

Mov Disord. 2003 Sep;18 Suppl 6:S2-12. Review.

PMID: 14502650

Lang AE, Lozano AM. Parkinson's disease. First of two parts.

N Engl J Med. 1998 Oct 8;339(15):1044-53. Review. No abstract available. PMID: 9761807

Polymeropoulos MH, Lavedan C, Leroy E, Ide SE, Dehejia A, Dutra A, Pike B, Root H, Rubenstein J, Boyer R, Stenroos ES, Chandrasekharappa S, Athanassiadou A, Papapetropoulos T, Johnson WG, Lazzarini AM, Duvoisin RC, Di Iorio G, Golbe LI, Nussbaum RL. Mutation in the alpha-synuclein gene identified in families with Parkinson's disease. Science. 1997 Jun 27;276(5321):2045-7. PMID: 9197268

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